Health care for you http://healthca.info Because health is the gold Sat, 22 Oct 2016 15:12:06 +0000 en-US hourly 1 SMECTA The active substance is Diosmectite 3 g http://healthca.info/2016/10/22/smecta-active-substance-diosmectite-3-g/ http://healthca.info/2016/10/22/smecta-active-substance-diosmectite-3-g/#respond Sat, 22 Oct 2016 15:11:48 +0000 http://healthca.info/?p=1461 Drug SMECTA The active substance is Diosmectite 3 g  Symptomatic treatment of  acute diarrhea, chronic diarrhea in children and infants in addition to oral rehydration and in adults No-Spa  Indicated for Colic biliary pain due to smooth muscle spasm Diatabs treatment of acute and chronic diarrhea in nonspecific bowel diseases NORMAGUT indications for maintenance of a […]

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Drug SMECTA The active substance is Diosmectite 3 g  Symptomatic treatment of  acute diarrhea, chronic diarrhea in children and infants in addition to oral rehydration and in adults

No-Spa  Indicated for Colic biliary pain due to smooth muscle spasm

Diatabs treatment of acute and chronic diarrhea in nonspecific bowel diseases

NORMAGUT indications for maintenance of a well-functioning intestinal flora and a good intestinal health

1. IDENTIFYING THE MEDICATION

A) Name: SMECTA, powder for drinkable suspension in sachet.

B) Composition:

The active substance is Diosmectite: 3 g The other components are: Glucose monohydrate. Sodium saccharin, orange- vanilla flavour (containing saccharose)

C) Pharmaceutical form:

Powder for drinkable suspension Box containing 30 or 60 sachets

D) Pharmaco-therapeutics class:

Other intestinal adsorbents

E) Marketing Authorisation Holder/distributon IPSEN Pharma

65 quai Georges Gorse 92100 Boulogne- Billancout.

F) Manufacturer name and address: BEAUFOUR IPSEN Industrie

Rue Ethe Virton 28100 Dreux – France

SMECTA The active substance is Diosmectite 3 g

2. INDICATION:

– Symptomatic treatment of acute diarrhea in children and infants in addition to oral rehydration and in adults;

– Symptomatic treatment of chronic diarrhea;

– Symptomatic treatment of pain associated with oesogastroduodenal and colonic disease

3. CONTRA-INDICATION:

– Hypersensitivity to diosmectite or to one of the excipients

– Due to the presence of glucose and saccharose, this medication is contraindicated for patients who are fructose intolerant.

4. PRECAUTION AND WARNING:

If the problem does not disappear within 7 days, consult your doctor.

If the pain is associated with a high temperature or vomiting, consult your doctor immediately.

Smecta must be used with precaution if you have a history of severe constipation.

In children and infants, the treatment of acute diarrhea must be accompanied by the early administration of an oral rehydration solution (ORS) to avoid dehydration.

5. INTERACTION WITH MEDICATIONS AND OTHER INTERACTION:

This product’s absorbent properties may interfere with the absorption periods and/or rates of another substance. It is recommended that this medication is not taken with any other medication.

6. PREGNANCY AND LACTATION:

During pregnancy and breast feeding, you should always ask the advice of your doctor or pharmacist before taking any medication.

7. POSOLOGYAND METHOD OF ADMINISTRATION:

a) Dosage:

Treatment of acute diarrhea Children and infants:

– Up to one year: 2 sachets a day for 3 days, then 1 sachet a day

– One year and older: 4 sachets a day for 3 days, then 2 sachets a day.

Adults:

An average of 3 sachets a day. In practice, the daily dosage can be doubled at the beginning of the treatment.

Other indications:

In children and infants:

– Up to one year: 1 sachet a day

– Between 1 and 2 years: 1 to 2 sachets a day

– After 2 years: 2 to 3 sachets a day.

In adults:

An average of 3 sachets a day. b) Method of administration: Orally The content of the sachet must be mixed in suspension directly before use. Preferably to be taken:

– After meals, if oesophagite,

– Between meals, for other indications.

C) Overdose:

If you take too much Smecta, contact your doctor or pharmacist immediately

d) Forget to take one or more doses:

Do not take double dose to make up for the single dose you have forgotten to take.

8. ADVERSE EFFECTS

As with any active ingredient, this medication can cause more or less embarrassing effects in certain people.

– Constipation, usually resolving with the reduction of the dose, but in rare cases, it can lead to the treatment being stopped.

– Flatulence.

– Vomiting.

Whilst post-marketing experience, very rare cases of allergic reactions including urticaria rashes, pruritis and angio- oedema have been reported. Cases of constipation worsening have also been reported.

– Inform your doctor or pharmacist of any adverse or embarrassing event that is not included in this leaflet

9. PHARMACODYNAMIC PROPERTIES SMECTA

due to its structure in leaves and its high plastic viscosity, has a significant digestive mucous covering capacity.

SMECTA, by interacting with mucus glycoproteins, increases the mucous gel’s resistance to attack.

SMECTA, by acting on the digestive mucous barrier and its high fixation capacity, protects the digestive mucous. SMECTA is radio- transparent, does not colour stools and, at the usual doses, does not affect the physiological intestinal transit time.

The combined results of the 2 double blind randomised studies that compare the efficacy of SMECTA against placebo and which included 602 patients aged between 1 and 36 months, suffering from acute diarrhea, demonstrate a significant reduction in stool output emitted during the first 72 hours, in the group of patients treated by SMECTA, in addition to oral rehydration.

Given the structure of diosmectite, SMECTA is neither absorbed nor metabolised.

11. SHELF – LIFE: 3 years

12. SPECIAL STORAGE CONDITION: A dry place, below 25C

13. NATURE AND CONTENTS OF CONTAINER

Sachet (Kraft paper, Aluminum foil, Polyethylene) containing 3.760 g of powder for oral suspension

KEEP OUT OF REACH OF THE CHILDREN DO NOT EXCEED THE EXPIRY DATE THAT APPEARS ON THE OUTER CARTON.

Children and infants:

The content of the sachet may be mixed in a bottle of 50 ml of water to be given during the day, or mixed with a semi-liquid food, such as broth, compote, puree, baby food…

Adults:

The content of the sachet may be mixed with half a glass of water.

Read the insert leaflet carefully before use. For more information, please see a doctor.

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Diatabs composition Activated Attapulgite 600 mg http://healthca.info/2016/10/21/diatabs-composition-activated-attapulgite-600-mg/ http://healthca.info/2016/10/21/diatabs-composition-activated-attapulgite-600-mg/#respond Fri, 21 Oct 2016 15:01:29 +0000 http://healthca.info/?p=1458 Drug Diatabs have composition Attapulgite 600 mg, treatment of acute and chronic diarrhea in nonspecific bowel diseases, Irritable bowel syndrome. NORMAGUT indications for maintenance of a well-functioning intestinal flora and a good intestinal health No-Spa 40 mg Indicated for Colic biliary pain due to smooth muscle spasm OpeCipro 500mg indicated for severe infections COMPOSITION Each […]

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Drug Diatabs have composition Attapulgite 600 mg, treatment of acute and chronic diarrhea in nonspecific bowel diseases, Irritable bowel syndrome.

NORMAGUT indications for maintenance of a well-functioning intestinal flora and a good intestinal health

No-Spa 40 mg Indicated for Colic biliary pain due to smooth muscle spasm

OpeCipro 500mg indicated for severe infections

COMPOSITION

Each tablet contains:

Activated Attapulgite  600 mg

Excipients: Pregelatinized Starch, Starch, Magnesium Stearate.

Diatabs composition Activated Attapulgite  600 mg

DESCRIPTIONS

New Diatabs with activated attapulgite, exerts highly effective adsorptive property to eliminate toxins, bacteria and enteroviruses that cause diarrhea and other gastrointestinal infections.

New Diatabs absorbs watery part of inflammatory secretions to help improve consistency of stools. In addition, New Diatabs coats and protects the inflamed mucous membrane of the intestinal tract.

INDICATIONS

– For symptomatic treatment of acute and chronic diarrhea in nonspecific bowel diseases.

– Irritable bowel syndrome.

DOSAGE AND INSTRUCTION FOR USE

  1. Adults and Children 12 years old and over: administer orally 2 tablets after every bowel movement. Not to exceed 14 tablets in 24 hours.
  2. Children 6 to below 12 years old: administer orally 1 tablet after every bowel movement. Not to exceed 7 tablets In 24 hours.
  3. Children 3 to below 6 years old: administer orally 1/2 tablet after every bowel movement. Not to exceed 3 and a hall tablets In 24 hours.
  4. Children up to 3 years old: Use and dose must be directed by a doctor.

CONTRAINDICATIONS

Hypersensitive to attapulgite.

In children with acute diarrhea, use Is not recommended.

Patients with stenotic lesions In the gastrointestinal tract.

PRECAUTIONS

– Use of Diatabs for children under 6 years of age only when directed by a doctor.

– Attapugite should not be used for patients with high fever, mucous or bloody stools unless directed by a doctor

– If symptoms persist after 2 days, consult a doctor.

– Sufficient rehydration and electrolytes must be supplemented concomitantly for diarrheal patients with dehydration (fluid loss).

PREGNANCY AND LACTATION

Attapulgite is considered safe.

SIDE-EFFECTS

Diatabs may cause constipation – usually mild and transient.

Using attapulgite in a long time or with high dose can cause phosphor insufficiency because of increasing aluminium absorption of the body.

Please inform your doctor of all undesirable effects upon drug administration.

OVERDOSE AND TREATMENT

In the event of overdose, attapulgite should be discontinued and the stomach should be emptied by gastric lavage.

DRUG INTERACTIONS

Concurrent use of oral medications with attapugite may impair absorption of these medications resulting in decreased therapeutic effectiveness. It is recommended that attapulgite be administered at least 2 to 3 hours before or after other oral medications.

PRESENTATION

Box of 25 strips x 4 tablets.

STORAGE : Store at temperatures not exceeding 30°C.

SHELF-LIFE : 36 months from manufacturing date.

REDUCES frequency of bowel movement

IMPROVES consistency of loose or watery stools

RELIEVES cramps due to diarrhea

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Buscopan contains 10 mg hyoscine butylbromide http://healthca.info/2016/10/19/buscopan-contains-10-mg-hyoscine-butylbromide/ http://healthca.info/2016/10/19/buscopan-contains-10-mg-hyoscine-butylbromide/#respond Wed, 19 Oct 2016 14:51:37 +0000 http://healthca.info/?p=1454 Drug Buscopan have composition hyoscine butylbromide 10mg, Indications for Gastrointestinal tract spasm, spasm and dyskinesia of the biliary system, genito-urinary tract spasm. No-Spa 40 mg Indicated for Colic biliary pain due to smooth muscle spasm  in connection MEPRAZ treatment for Gastric ulcer, Gastroesophageal Reflux Disease Duphalac Indications for Constipation, haemorrhoids, post colonic/anal surgery Composition each […]

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Drug Buscopan have composition hyoscine butylbromide 10mg, Indications for Gastrointestinal tract spasm, spasm and dyskinesia of the biliary system, genito-urinary tract spasm.

No-Spa 40 mg Indicated for Colic biliary pain due to smooth muscle spasm  in connection

MEPRAZ treatment for Gastric ulcer, Gastroesophageal Reflux Disease

Duphalac Indications for Constipation, haemorrhoids, post colonic/anal surgery

Composition

each sugar-coated (sc.) tablet contains 10.0 mg hyoscine butylbromide.

Excipients: dibasic calcium phosphate, maize starch, starch soluble, aerosil 200, tartaric acid, stearic acid, polyvidone, saccharose, talc, acacia, titanium dioxide, polyethylene glycol 6000, carnauba wax, beeswax white.

Buscopan contains 10 mg hyoscine butylbromide

Indications

Gastrointestinal tract spasm, spasm and dyskinesia of the biliary system, genito-urinary tract spasm.

Dosage and administration

Unless otherwise prescribed by the physician, the following dosages are recommended:

Adults and children over 6 years: 3-5 times daily 1-2s.c. tablets.

Contraindications

BUSCOPAN is contraindicated in:

– patients who have demonstrated prior hypersensitivity to hyoscine butyibromide or any other component of the product

– myasthenia gravis

– megacoton

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and precautions”) the use of the product is contraindicated.

Special warnings and precautions

in case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting or blood in stool, medical advice should immediately be sought.

Because of the potential risk of anticholinergic complications, caution should be used in patients prone to narrow angle glaucoma as well as in patients susceptible to intestinal or urinary outlet obstructions and in those inclined to tachyarrhythmia.

One sugar-coated tablet of 10 mg contains 41.2 mg sucrose, resulting in 411.8 mg sucrose per maximum recommended daily dose. Patients with the rare hereditary condition of fructose intolerance should not take this medicine.

Interactions

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds) may be intensified by BUSCOPAN.

Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution of the effects of both drugs on the gastrointestinal tract.

The tachycardic effects of beta-adrenergic agents may be enhanced by BUSCOPAN.

Fertiliy, pregnancy and lactation

There is limited data from the use of hyoscine butylbromide in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

There is insufficient information on the excretion of BUSCOPAN and its metabolites in human milk.

As a precautionary measure, it is preferable to avoid the use of BUSCOPAN during pregnancy and lactation.

No studies on the effects on human fertility have been conducted.

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Side effects

Many of the listed undesirable effects can be assigned to the anticholinergic properties of BUSCOPAN. Anticholinergic side effects of BUSCOPAN are generally mild and self-limited.

Immune system disorders

Anyphylactic shock, anaphylactic reactions, dyspnoea, skin reactions (e.g. urticaria, rash, erythema, pruritus) and other hypersensitivity.

Cardiac disorders Tachycardia.

Gastrointestinal disorders Dry mouth.

Skin and subcutaneous tissue disorders Dyshidrosis.

Renal and urinary disorders Urinary retention.

Please inform your doctor any undesirable effects occurs during treatment.

Overdose

Symptoms

In the case of overdose, anticholinergic effects maybe observed.

Therapy

If required, parasympathomimetic drugs should be administered. Ophthalmologicai advice should be sought in cases of glaucoma urgently. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis: intubation, artificial respiration should be considered. Catheterisation may be required for urinary retention. In addition, appropriate supportive measures should be used as required.

Pharmacological properties

BUSCOPAN exerts a spasmolytic action on the smooth muscle of the gastro-intestinal, biliary and genito-urinary tracts. As a quaternary ammonium derivative, hyoscine butylbromide does notenter the central nervous system. Therefore, anticholinergic side effects at the central nervous system do not occur. Peripheral anticholinergic action results from a ganglion-blocking action within the visceral wall as well as from an anti-muscarinic activity.

Shelf life 36 months.

Special precautions for storage

Store in the original packaging to protect the contents from moisture. Store below 30°C.

Store in a safe place out of the reach of children.

Availability

10 sugar-coated tablets per blister. 1,2, 5 or 10 blisters per box.

20 sugar-coated tablets per blister. 5 blisters per box

Manufactured by Delpharm Reims 10 rue Colonel Charbonneaux 51100 Reims. France.

Read carefully enclosed leaflet before use.

For further information please contact your Doctor or Pharmacist.

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TRYMO TABLETS COLLOIDAL BISMUTH SUBCITRATE (C B S) http://healthca.info/2016/10/17/trymo-tablets-colloidal-bismuth-subcitrate-c-b-s/ http://healthca.info/2016/10/17/trymo-tablets-colloidal-bismuth-subcitrate-c-b-s/#respond Mon, 17 Oct 2016 16:24:29 +0000 http://healthca.info/?p=1451 Drug TRYMO have composition Bismuth Subcitrate equivalent to 120 mg bismuth trioxide, indications for Duodenal ulcers, Chronic active gastritis, Benign gastric ulcer, Non-ulcer dyspepsia. MEPRAZ treat of for Gastric ulcer, Gastroesophageal Reflux Disease DEBRIDAT treat of pain related to functional disturbances of the gastrointestinal tract bile ducts Phosphalugel for the treatment of pain, acidity or burning […]

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Drug TRYMO have composition Bismuth Subcitrate equivalent to 120 mg bismuth trioxide, indications for Duodenal ulcers, Chronic active gastritis, Benign gastric ulcer, Non-ulcer dyspepsia.

MEPRAZ treat of for Gastric ulcer, Gastroesophageal Reflux Disease

DEBRIDAT treat of pain related to functional disturbances of the gastrointestinal tract bile ducts

Phosphalugel for the treatment of pain, acidity or burning in the stomach or oesophagus

Also known as TRIPOTASSIUM DICITRATO BISMUTHATE (T.D.B.)

COMPOSITION

Each film-coaled tablet of TRYMO contains Colloidal Bismuth Subcitrate equivalent to 120 mg bismuth trioxide.

Ingredients: Maize starch, polyvinyl pyrrolidone, isopropyl alcohol, purified talc, magnesium stearate, shellac.

TRYMO TABLETS COLLOIDAL BISMUTH SUBCITRATE

PHARMACOLOGY

TRYMO (Colloidal Bismuth Subtitrate) is the colloidal bismuth salt of citric add. it is effective in alleviating symptoms in patients with gastric or duodenal ulcer. It also accelerates the healing of gastric and duodenal ulcers. The mode of action is distinct from that of other anti-ulcer drugs including H2-receptor antagonists.

The following pharmacological actions were observed in expenmental animals:

1. Bismuth oxide precipitated from CBS by the action of acid in the stomach, forms a tenacious layer upon the digestive mucosa.

2. By fixing chloride ion and formation of insoluble bismuth oxychloride, diffusion of bismuth ion into the circulation is prevented and thereby CBS toxicity is eliminated.

3. Bismuth ions inhibit the growth of Enterococci, Staphylococci. Pseudomonas, and thereby alter the microbial flora in the G.l. tract

4. Bismuth ions increase the secretion of mucus, which inhibits the activity of hydrochloric add and pepsin.

5. It exerts an anti-ulcer effect in rats and guinea pigs in which ulcers are induced by various means.

6. In-vitro studies have shown that CBS together with gastric glycoproteins forms a complex’, which markedly retards the migration of H* ions. The formation of this layer at the ulcer site acts as a diffusion barrier to hydrochloric acid.

The usual postulates for pharmacological actions in human are:

  1. At pH less than 5, TRYMO forms a predpitate of bismuth oxychloride and bismuth citrate. By chelate formation, protein degradation products together with the precipitate obtained from TRYMO form an insoluble layer at the ulcer site.
  2. TRYMO also binds with mucus forming a glycoprotein-bismuth complex providing a diffusion barrier to HCL without affecting the ion change properties of the mucus.
  3. TRYMO enhances the increase of macrophages, which may assist early healing of the damaged mucosa.
  4. TRYMO has a direct bactericidal effect on Helicobacter pylori: vacuolisation occurred within the bacteria, resulting in fragmented cell walk and. in some cases, complete condensation of the cell contents. Bismuth was seen deposited in aggregates on the surface and within the bacteria.
  5. TRYMO has littie effect on the acidity of gastric fluid.

PHARMACOKINETICS

Absorption: The action of TRYMO is fully dependent on the local action at the ulcer site. However, very small amounts of bismuth are absorbed from the G.l. tract. The absorption is initially dose-dependent and reaches the dynamic equilibrium (steady state level) after 4 weeks of administration with the normal dosage of 480 mg/day and no further rise in blood or urine levels at 5 and 6 weeks. The mean concentration was only 7 ng/ml, which is far below the alerting levels of 50 to 100 ng/ml.

Distribution: Studies carried out in animals show that most of the absorbed

bismuth reaches the kidneys with only trace amounts In other organs. In dogs with experimental ulcers, CBS was given for 3 weeks in doses 20 times as those recommended for man and the tissues were examined for bismuth concentrations by optical density measurements. The kidneys contained 34.3 ppm of bismuth and only traces in other organs, namely, stomach 4.3 ppm, liver 2.1 ppm. Spleen 0.7 ppm, mesenteric lymph nodes 1.6 ppm, blood less than 0.5 ppm. Human data on tissue distribution of TRYMO is not yet available. Bioavailability is not applicable since TRYMO acts locally.

Excretion: Most of the bismuth in TRYMO is excreted in the faeces as bismuth sulphate. The very small amount of bismuth, which may be absorbed, k eliminated via the kidneys. This excretion Is at a slow rate of about 2.6 % per day; mean urinary excretion levels were In the range of 411 to 639 mcg/24 hours during 4-6 weeks treatment period. Therefore a wash out period of about 2 months is required after each course of TRYMO before considering afresh treatment with TRYMO.

INDICATIONS

Duodenal ulcers. Chronic active gastritis. Benign gastric ulcer. Non-ulcer dyspepsia.

Colloidal bismuth subcitrate (Trymo) can be used as triple therapy (with metronidazole and either tetracycline or amoxicillin) to eradicate Helicobacter pylori.

CONTRAINDICATIONS

Severe renal insufficiency. TRYMO is not recommended during pregnancy  and lactation. TRYMO is not indicated in children.

DOSAGE AND ADMINISTRATION

TRYMO, two tablets twice a day on an empty stomach, half an hour before meals to be swallowed whole and not chewed. TRYMO should be used a initially for a period of 4 weeks and if required up to a maximum of 8 weeks. TRYMO should not be used as maintenance therapy after the maximum ) period of 8 week is over. If a new course of TRYMO tablets is contemplated.

it is advised to give a gap of at least 8 weeks before the therapy is restarted.

When used as a part of triple therapy. 1 tablet of Trymo is given 4 times daily for 2 weeks.

ADVERSE DRUG REACTIONS

Nausea, vomiting and diarrhoea have been occasionally reported with the  use of TRYMO. Headache and giddiness have been mentioned by some investigators. Darkening of the stools is due to the excretion of bismuth   sulphide. Inform your physician the unwanted effects afterusing.

PRECAUTIONS

Though no reports of bismuth encephalopathy following the use of colloidal bismuth subcitrate in the recommended doses have been made, the  possibility should be kept in mind and overdosage should be avoided. For the same reason, long-term usage (maintenance therapy) is not recommended.

There Is insufficient information available on use of colloidal bismuth subettiate during pregnancy and lactation.

The product should be consumed before the expiry date.

DRUG INTERACTIONS

The absorption of iron, calcium or tetracycline may be reduced following theirconcomitant administration with TRYMO.

Antacids or milk given along with TRYMO may form a chelate with and may interfere with the action of colloidal bismuth subcitrate. Thus, it is advised that food or antacids should not be taken within 30 minutes before or after administration of TRYMO.

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NORMAGUT – Saccharomyces Boulardii and Lactose Monohydrate http://healthca.info/2016/10/14/normagut-saccharomyces-boulardii-lactose-monohydrate/ http://healthca.info/2016/10/14/normagut-saccharomyces-boulardii-lactose-monohydrate/#comments Fri, 14 Oct 2016 14:57:54 +0000 http://healthca.info/?p=1447 NORMAGUT have composition Saccharomyces Boulardii 221.25 mg and Lactose Monohvdrate 28.75 mg, indications for maintenance of a well-functioning intestinal flora and a good intestinal health MEPRAZ treat of for Gastric ulcer, Gastroesophageal Reflux Disease Rovas Indication treatment of Lower, Upper respiratory tract infections : otitis, sore throat FORLAX treatment of constipation in adults and children […]

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NORMAGUT have composition Saccharomyces Boulardii 221.25 mg and Lactose Monohvdrate 28.75 mg, indications for maintenance of a well-functioning intestinal flora and a good intestinal health

MEPRAZ treat of for Gastric ulcer, Gastroesophageal Reflux Disease

Rovas Indication treatment of Lower, Upper respiratory tract infections : otitis, sore throat

FORLAX treatment of constipation in adults and children aged 8 years and above

COMPOSITIONS:

Each capsule contains:

Active ingredient: Lyophilized Saccharomyces Boulardii 221.25 mg and Lactose Monohvdrate 28.75 mg

Excipients: Anhydrous Lactose, Magnesium stearate, Gelatin, Titanium dioxide(E171), Iron oxide hydrate (El72) (yellow iron oxide), Chlorophyllin-copper complex (E141).

NORMAGUT - Saccharomyces Boulardii and Lactose Monohvdrate

INDICATIONS of NORMAGUT

For establishment and maintenance of a well-functioning intestinal flora and a good intestinal health.

Treatment and prevention of Clostridium difficile diarrhea and antibiotic associated diarrhea.

DOSAGE AND ADMINISTRATIONS

Children over 12 years and adults:

For establishment and maintenance of a well-functioning intestinal flora and a good intestinal health or treatment of diarrhea: 1 capsule once or twice daily.

For prevention of traveller’s diarrhea: 1 capsule once or twice daily starting 5 days before departure.

Children 2-12 years old:

Take 1 capsule once or twice daily by taking off the capsule shell and putting the content of a capsule into a feeding bottle or a glass of water or a glass of juice.

Children below 2 years: should consult a doctor.

CONTRAINDICATIONS:

It should not be used with known hypersensitivity to yeast or any component of capsule. Immunocompromised patients such as HIV infections, organ transplantation and radiotherapy.

SPECIAL WARNING & PRECAUTIONS:

Should consult physician, if diarrhea lasts longer than 2 days.

ADVERSE EFFECT

May often cause flatulence

Inform your physician of any adverse effects while using NORMAGUT

USING FOR PRENANCY AND LACTATION

During pregnancy, NORMAGUT should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this product passes into breast milk. When breast-feeding, Consult your doctor before using.

EFFECTS ON ABILITY TO DRIVE AND OPERATE MACHINE

No data available.

INTERACTIONS

Taking with antimycotic drugs may impair the effect of Saccharomyces boulardii and taking with monoamino-oxidase inhibitors may increase the blood pressure.

OVERDOSE

If you have considerably overdosed Normagut, side effects may occur to an increased extent. In this case, you should consult a doctor.

STORAGE: Below 30°C, in dry place, protect from direct sunlight.

SHELF LIFE : 24 month from manufactured date.

PACKING STYLES: Box of 3 blister x 10 tablets.

SPECIFICATION: In-House RECOMMENDED:

Keep all medicines out of the reach of children.

–        Don’t not use NORMAGUT if it is out of date.

–        Don’t not use NORMAGUT if there are any signifiicant change in appearance of capsule.

–        Read carefully the leaflet before use.

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ELTHON 50mg Tablet ( Itopride hydrochloride ) http://healthca.info/2016/10/13/elthon-50mg-tablet-itopride-hydrochloride/ http://healthca.info/2016/10/13/elthon-50mg-tablet-itopride-hydrochloride/#respond Thu, 13 Oct 2016 15:27:41 +0000 http://healthca.info/?p=1443 Drug ELTHON 50mg have composition itopride hydrochloride, Indication for Gastrointestial symptoms in chronic gastritis : feeling of enlarged abdomen, upper abdominal pain, anorexia, heartburn, nausea and vomiting MEPRAZ treat of for Gastric ulcer, Gastroesophageal Reflux Disease Maalox treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia OpeCipro 500mg is indicated for severe infections PHYSICOCHEMISTRY Nonproprietary name: […]

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Drug ELTHON 50mg have composition itopride hydrochloride, Indication for Gastrointestial symptoms in chronic gastritis : feeling of enlarged abdomen, upper abdominal pain, anorexia, heartburn, nausea and vomiting

MEPRAZ treat of for Gastric ulcer, Gastroesophageal Reflux Disease

Maalox treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia

OpeCipro 500mg is indicated for severe infections

PHYSICOCHEMISTRY

Nonproprietary name: ELTHON 50mg ( itopride hydrochloride ) Chemical name: N-[4-[2-(Dimethylamino) ethoxy]benzyl]-3,4- dimethoxybenzamide monohydrochloride Molecular formula: C20H26N2O4, HCL

Description: itopride hydrochloride occurs as white to pale yellowish white crystals or crystalline powder. It is odorless and has a bitter taste. It is very soluble in water, freely soluble in methanol or in glacial acetic acid, sparingly soluble in ethanol and practically in-soluble in acetic anhydride or in ether. The pH of the solution (1->10) is 4.0 to 5.0.

Melting point: 193 to 198°C

Partition coefficient: 5.7 [pH7.4, 1-octanol/buffer]

ELTHON 50mg Tablet - Itopride hydrochloride

PHARMACOKINETIC:

1. Serum concentrations

The serum concentrations and pharmacokinetic parameters in healthy adults, after single oral administration of 50 mg of itopride hydrochloride in the fasting state, are shown in the following Figure 1 and Table 1.

Fig. 1: Serum Concentrations after single oral administration of 50mg of itopride hydrochloride (Healthy adults in the fasting state, mean +- S.E.)

2. Distribution

Results of Animal Experiments

– The concentrations reached the maximum in almost all tissues at 1 to 2 hours after a single oral dose of 5 mg/kg of 14C-itopride hydrochloride to rats, and the level at 2 hours after administration was high in the kidneys, small intestines, liver, adrenal glands, and stomach in the order of the level (high to low) and the transfer into the central nervous system, such as brain and spinal marrow, was minimal.

– In intraduodenal administration of 5 mg/kg of ,14C-itoprlde hydrochloride to rats, the radioactivity concentrations In the gastric muscular layers were about two times as high as those in the blood.

– Excretion in breast milk; When 5 mg/kg of 14C-itopride hydrochloride was orally administered to rats, concentrations in breast milk in comparison to serum concentrations of radioactivity were 1.2 times higher in C max, 2.6 times higher in AUC, and 2.1 times higher in T 1/2

3. Metabolism and Excretion

–  Al a single dose of 100 mg of itopride hydrochloride was orally administered to

healthy adults (6 men) In the fasting stale Urinary excretion rate within 24 hours

after administration was highest in the N-oxide form [67.54 % of the dose (89.41% of the urinary excretion)] and in the unchanged compound was the second (4.14%) and in the others were minimal.

– In the experiments using microsomes that express a human CYP or flavine monooxygenase (FMO), It was found that FM01 and FM03 were involved in the production of main metabolic N-oxide form. However, no N-oxygenase activity of CYP1A2, -2A6, -2B6, -2C6, -2C9, 2C19, 2D6. 2E1, or 3A4 was detected.

4. Others

Serum protein binding ratio: Serum protein binding ratio was 96% after orally administration at a single dose of 100mg of itopride hydrochloride to healthy adults (6 men) in the fasting state.

CLINICAL STUDIES:

Open clinical studies and double-blind comparative studies of ELTHON 50mg were conducted. As the results, the efficacy rate (in the “moderately improved” or better cases) of ELTHON 50mg for gastrointestinal symptoms in chronic gastritis was 77.6% (277/357 patients). (At the approval)

PHARMACOLOGY:

1. Mechanism of action

ELTHON 50mg increases the release of acetylcholine (ACh) through dopamine D2-receptor antagonistic action and inhibits decomposing released ACh through its acetylcholine esterase (AChE) inhibitory action, resulting in enhancement of gastrointestinal motility.

2. Enhancement of the Gastrointestinal Motility Activation of the gastric motility

ELTHON 50mg ( Itopride hydrochloride ) activates the gastric motil-ity dose-dependently in conscious dogs.

– Activation of the gastric emptying ability itopride hydrochloride activates gastric emptying ability in humans, dogs and rats

3. Alleviation of Vomiting

ELTHON 50mg ( Itopride hydrochloride ) inhibits apomorphine-induced vomiting dose-dependently in dogs

INDICATIONS

Gastrointestial symptoms in chronic gastritis ( feeling of enlarged abdomen, upper abdominal pain, anorexia, heartburn, nausea and vomiting )

CONTRAINDICATIONS:

ELTHON is contraindicated in the patients with a history of hypersensitivity to any ingredients of this product. It should not be used during pregnancy unless benefits outweigh the potential risk.

DOSAGE AND ADMINISTRATION:

The usual adult dosage for oral use is 150 mg of itopride hydrochloride (3 tablets) daily in three divided doses before meals. The dose may be reduced according to patient’s age and symptoms.

PRECAUTIONS:

1. Important precautions

– ELTHON 50mg should be used with caution since it enhances the action of acetylcholine.

– This product should not be used aimlessly for a long term when no improvement of gastrointestinal symptoms is observed.

2. Drug Interactions

Precautions for co-administration (ELTHON should be administered with care when co-administered with the following drugs.)

Drugs Signs, symptoms, and treatment Mechanism and risk factors
Anticholinergic Drugs: Tiquizlum bromide, scopolamine butyl bromide,

timepidium bromide, etc…

Symptoms:There is a possibility of reducing the action of this product that activates gastrointestinal motility (cholinergic action). Mechanism:

Inhibitory action of Anticholinergic agent may pharmacologically work against the action of this product

3. Adverse Reactions

At the approval: Adverse reactions were observed in 14 (2.45%) of 572 patients (19 events, 3.32%). The major adverse reactions were diarrhea (4 events, 0.70%), headache (2 events, 0,35%), abdominal pain (2 events, 0.35%), Abnormalities in laboratory data were Leucopenia (4 events), increased prolactin (2 events), etc.

At the end of reexamination:

Adverse reactions were observed in 74 (1.25%) of 5,913 patients (104 events, 1.76%). The major adverse reactions containing abnormalities in laboratory data were diarrhea (13 events, 0.22%), abdominal pain (8 events, 0.14%), constipation (8 events, 0.14%), increased AST (GOT) (8 events, 0.14%) increased ALT (GRT) (8 events, 0.14%), etc.

* Clinically significant adverse reactions

–        Shock and Anaphylactoid reaction (incidence unknown): Shock and anaphylactoid reaction may occur, and the patient should be carefully monitored. If any signs of shock and anaphylactoid reaction such as hypotension, dyspnoea, larynx oedema, urticaria, pallor and diaphoresis etc., are observed, administration of the drug should be discontinued and appropriate therapeutic measures taken.

–        Hepatic function disorder and Jaundice (incidence unknown): Hepatic function disorder and jaundice with increased AST (GOT), ALT(GPT) and 7-GTP etc., may occur, and the patient should be carefully monitored. If such abnormalities are observed, administration of the drug should be discontinued and appropriate theraoeutic measures taken.

* Other adverse reactions (AR)

0,1% <= AR < 5% AR <0,1% Incidence

unknown

Hypersensitivity Rash, redness, itching, etc
Exlrnpyramidal symptoms Tremor, etc.
Endocrine Increased prolactin, etc Gynecomastia

etc.

Hematologic Thrombocytopenia, leucopenia, etc
Gastrointestinal Diarrhea,constipation, abdominal pain, etc Nausea, Increased saliva, etc,
Psychoneurologic Headache, irritated feeling, sleep disorder dizziness, etc
Hepatic Increased AST (GOT), Increased ALT (GPT), etc Increased y-GTP, Increased Al-P, etc
Renal Increased BUN. Increased creatinine, etc
Others Chest or back pain, fatigue

Note:

1) Incidence is unknown due to spontaneous reports.

2) If any abnormality Is observed, appropriate measures, such as discontinuation of the medication, should be taken,

4. Use In the Elderly

Since the elderly often have a physiological hypo-function, adverse reactions are liable to appear. The patients receiving this product, therefore, should be carefully observed, if any adverse reactions appear, appropriate measures such as reduction or interruption of the drug should be taken.

5. Use during Pregnancy, Delivery or Lactation

– ELTHON 50mg should be used in pregnant women or in women who may possibly be pregnant only If the expected therapeutic benefits outweigh the possible risks associated with treatment, (The safety of this product in pregnant women has not been established).

– It is ideal not to use this product in women during lactation, but if it Is necessary, breast feeding should be avoided during the treatment of this product. [It has been reported that itopride hydrochloride Is excreted in breast milk in the animal experiments (rats). [See “PHARMACOKINETICS” section]

6. Pediatric Use

The safety of this product in children has not been established (There are a few clinical experiences).

7. Effects on the ability to drive and use machines

Adverse drug reactions such as dizziness may occur. Under these conditions the ability to react may be decreased.

8. Precautions concerning use

Precautions regarding dispensing: For drugs that are dispensed In a press-through package (FTP), instruct the patient to remove the drug from the package prior to use. (It has been reported that, if the PTP sheet is swallowed, the sharp comers of the sheet may puncture the esophageal mucosa, resulting in severe complications such as medi-astinitis.)

PACKAGING: Box of 2 blisters x 10 tablets,

STORAGE: Store below 30eC, protect from light. Keep out of reach of children

SHELF LIFE:

3 years from the date of production. Don’t use beyond the expiry date Specification: Manufacturer’s.

Manufactured by: Abbott Japan Co., Ltd.

Read carefully the package Insert before use your doctor if you need any further information.

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DEBRIDAT contains 100 mg trimebutine maleate http://healthca.info/2016/10/11/debridat-contains-100-mg-trimebutine-maleate/ http://healthca.info/2016/10/11/debridat-contains-100-mg-trimebutine-maleate/#respond Tue, 11 Oct 2016 15:51:48 +0000 http://healthca.info/?p=1440 Drug DEBRIDAT have composition trimebutine maleate  100mg, Symptomatic treatment:of pain related to functional disturbances of the gastrointestinal tract bile ducts, of pain transit disturbances and intestinal discomfort related to intestinal disturbances No  Spa 40mg Indicated for Colic biliary pain due to smooth muscle spasm Maalox treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia 1. NAME […]

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Drug DEBRIDAT have composition trimebutine maleate  100mg, Symptomatic treatment:of pain related to functional disturbances of the gastrointestinal tract bile ducts, of pain transit disturbances and intestinal discomfort related to intestinal disturbances

No  Spa 40mg Indicated for Colic biliary pain due to smooth muscle spasm

Maalox treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia

1. NAME OF THE MEDICINAL PRODUCT DEBRIDAT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet of DEBRIDAT contains 100 mg trimebutine maleate.

DEBRIDAT contains 100 mg trimebutine maleate

3. PHARM ACETICAL FORM

Film coated tablet

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

Symptomatic treatment:

– of pain related to functional disturbances of the gastrointestinal tract and bile ducts.

– of pain transit disturbances and intestinal discomfort related to intestinal disturbances.

4.2. Posotogy and Method of Administration

Reserved for  use in adults only. The usual dosage is 1 tablet 3 times daily

In exceptional cases, the dosage may be increased up to maximum of 6 tablets per day.

4.3. Contraindications

Debridat is contraindicated in patients found to be  to trimebutine or to any components the formulation

4.4. Special Warnings and Special Precautions for Use

Absolute contraindications and precautions to this age been determined: no information found  of this review.

4.5 Interaction with Other Medicaments and Other Forms of Interaction

None Known

4.6 Pregnancy and Lactation

Pregnancy:

Studies in animals have not revealed any teratogenic effect. In the absence of any teratogenic effect no matonnative effect is expected in infact, to date, substances responsible for in humans have been revealed to be teratogenic in animals in the course of properly conducted studies in both species.

No sufficiently relevant data are currently available to be able to assess a potential malformative or fetotoxic effect of trimebutine when it is administered during pregnancy. Consequently, as a precautionary measure, it is preferable not to use trimebutine during the first trimester of pregnancy. In the absence of any expected harmful effect for either mother or child, the use of trimebutine during the 2nd and 3rd trimesters of pregnancy should only be considered if it is necessary.

Lactation

Breast-feeding is possible during treatment with trimebutine.

4.7. Effects on Ability to Drive and Use Machines

The effect of tiimebutine maleate on the ability to drive or operate machine has not been systematically evaluated.

4.8. Undesirable Effects

Rare cases of skin reactions have been reported during clinical studies.

4.9. Overdose

In the event of overdose, symptomatic treatment should be instigated

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

MUSCULOTROPIC ANTISPASMODIC (A: gastrointestinal tract and metabolism)

Gastrointestinal motility modifier. Peripheral enkephalinergic agonist.

Trimebutine stimulates intestinal motility (triggering phase-ill waves propagated by the migrating motor complex) and inhibits it in the event of prior stimulation.

5.2. Pharmacokinetic Properties

Peak blood levels obtained after 1 to 2 hours.

Rapid elimination, mainly in the urine: on average 70% in 24 hours.

5.3. Preclinical Safety Data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Lactose monohydrate, pregelatinized starch (maize), hypromellose, sodium starch glycollate, tartaric acid, silicone dioxide, magnesium stearate, macrogol 4000, titanium dioxide, purified water.

6.2. Incompatibilities None known.

6.3. Shelf-life : 36 months.

6.4. Special Precautions for Storage Store:  below 25°C.

6.5. Nature and Contents of Container:  Box of 2 blisters x 15 film coated tablets.

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No Spa 40 mg ( Drotaverine hydrochloride 40 mg ) http://healthca.info/2016/10/08/no-spa-40-mg-drotaverine-hydrochloride-40-mg/ http://healthca.info/2016/10/08/no-spa-40-mg-drotaverine-hydrochloride-40-mg/#comments Sat, 08 Oct 2016 09:34:37 +0000 http://healthca.info/?p=1435 Drug No Spa have composition drotaverine hydrochloride 40 mg, is a smooth muscle spasmolytic medecine : Indicated for Colic biliary pain due to smooth muscle spasm  in connection with biliary tract diseases cholecystolithiasis. cholangiolithiasis, cholecystitis … MEPRAZ treat of for Gastric ulcer, Gastroesophageal Reflux Disease Phosphalugel treatment of pain, acidity or burning in the stomach […]

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Drug No Spa have composition drotaverine hydrochloride 40 mg, is a smooth muscle spasmolytic medecine : Indicated for Colic biliary pain due to smooth muscle spasm  in connection with biliary tract diseases cholecystolithiasis. cholangiolithiasis, cholecystitis …

MEPRAZ treat of for Gastric ulcer, Gastroesophageal Reflux Disease

Phosphalugel treatment of pain, acidity or burning in the stomach or oesophagus

Maalox treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia

FORM AND PRESENTATION: Tablet

Blister of 10 tablets, box of 2 blisters and box of 5 blisters.

COMPOSITION

Drotaverine hydrochloride 40 mg

Excipients qs. for 1 tablet: lactose monohydrate, maize starch, talc, magnesium stearate.

No Spa 40 mg - Drotaverine hydrochloride 40 mg

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties ATC A03A 002

Pharmacotherapeutic group: smooth muscle spasmolytic agent indicated tor treatment of pain syndromes of various organs: gastrointestinal, biliary, urogenital and vascular systems.

No Spa 40 mg ( Drotaverine ) is an isoquinoline derivative, having smooth muscle spasmolytic due to inhibit PDE IV (c AMP specific phosphodiesterases) in vitro without inhibiting the PDE III and PDE V isoenzymes.

PDE4 inhibitors have myorelaxant properties and anti-inflammatory activity. As a consequence of inhibiting the PDE IV enzyme it results in the increase of the intracellular cAMP concentration which by inactivating the myosin light chain kinase enzyme (MICK) and the intracellular calcium ion (Ca++) concentration declines, thus leading to the relaxation of the smooth muscle. Functionally, PDE IV appears to be very important in reducing smooth muscle contractile activity, suggesting that selective PDE IV inhibitors might be useful in the treatment of hypermotility disorders and various diseases associated with spastic conditions of the gastrointestinal, urogenital system.

The enzyme that hydrolyses cAMP in myocardial and vascular smooth muscle cells is mainly the PDE III isoenzyme, this explains, that drotaverine is an effective spasmolytic agent without serious cardiovascular adverse effects and strong cardiovascular therapeutic activity.

It is effective in case of smooth muscle spasms of both neural- and muscular origin.

Independently from the type of autonomous innervation, drotaverine acts on the smooth muscles found in the gastrointestinal, biliary, urogenital and the vascular system.

Due to its vasodilatator effect it increases the tissue circulation.

Droatevrine’s effect is stronger than papaverine’s, its absorption is more rapid and more complete, and it bonds less to the serum proteins.

Drotaverine free of anticholinergic effects.

Pharmacokinetic properties

Drotaverine is rapidly absorbed after oral administration. Volume of distribution = 200 litres.

It is highly bound to human plasma proteins (95-98%). especially to albumin, gamma and beta globulins. Drotaverine might cross the placental barrier.

is reached within 45-60 min after oral administration and after its first pass metabolism the 65% of the administered dose reaches the circulation unchanged.

It is metabolized in the liver. Its biological half-life is 16-22 hours.

Practically within 72 hours it disappears from the body. More than 50% of it is excreted in the urine and about 30% in the faeces. It is mainly excreted in the form of main metabolites: its unchanged form cannot be detected in the urine.

THERAPEUTIC INDICATIONS

No Spa 40 mg is a smooth muscle spasmolytic medecine.

Colic biliary pain due to smooth muscle spasm in connection with biliary tract diseases cholecystolithiasis. cholangiolithiasis, cholecystitis, pericholecyctitis, cholangitis and papillitis.

Colic renal pain due to smooth muscle spasm in urinary tract diseases: nephrolithiasis, ureterolithiasis. pyelitis, cystitis and cramp of urinary bladder.

As adjuvant treatment:

– Abdomen pain oi colic abdomen pain due to smooth muscle spasm of gastrointestinal origins: gastric and duodenal ulcer, gastritis, cardia and pylorus spasm, enteritis and colitis, spastic colitis with constipation and meteoristic forms of irritable colon syndrome. Drotaverin improves quickly and effectively anti-spasmolytic adbomen pain but not faints the emergency abdomen symptoms.

– In gynaecological diseases: dysmenorrhoea.

Adults:

Adults; the usual average daily dose is 120-240 mg/day (in 2-3 divided doses). Similar dosage: 1-2 tablets, 3 times/day.

Children:

For the children, the usual average daily dose is:

– Children between 1 and 6 years old: 40-120 mg/day (in 2-3 divided doses). Similar dosage: 1/2 = 1 tablet. 2-3 times/day.

– Children over 6 years of age: 80-200 mg/day (in 2 5 divided doses). Similar dosage: 1 tablet. 2-5 times/day.

CONTRA-INDICATIONS

DO NOT USE No Spa 40 mg in the following cases:

  1. Hypersensitivity to the active substance or to any of the excipients.
  2. Severe renal, hepatic or cardiac insufficientcy flow EF syndrome)
  3. A-V block of ll-HI degree.

– Tablet forms should not be administered to babies under 1 year old.

PRECAUTIONS

Special warnings and precautions for use Drotaverine’s administration requires increased caution in case of low blood pressure.

When taken according to the recommended dose regimen, the total daily dose intake of lactose is unsuitable for people with lactase insufficiency, galactosaemia or glucose-galactose malabsorption syndrome.( No-spa 40mg tablet contains 50mg of lactose).

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Together with levodopa, as the antiparkinson effect may decreases, and tremor, rigidity become aggravated.

PREGNANCY AND LACTION

Before to apply any medicine, consult at your medical doctor or pharmacist.

Pregnancy:

There is no evidence of teratogenicity and embryotoxicity from retrospective human and animal studies by oral route. Nevertheless, caution should be taken when prescribed during pregnancy.

Lactation:

There are no adequate data on the use of drotaverine in lactaction women, this medicine should not recommended for prescribing in these subjects.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

In therapeutic doses, drotaverine has no effect on ability to drive or operate machinery during oral treatment.

Patients should be instructed that if they experience vertigo, they should avoid potentially hazardous tasks such as driving or operating machines.

UNDESIRABLE EFFECTS

The following related drotaverine adverse reactions from clinical investigations were listed below by frequency grouping Very common (>1/10), common (>1/100. <1/10), uncommon (>1/1000, <1/100), rare (>1/10.000, <1/1000) and very rare (<1/10.0001 and system organ class:

– Gastrointestinal disorders:

Rare: nausea, constipation.

– Central and peripheral nervous system disorders:

Rare: headaches, dizziness, insomnia.

– Cardiovascular system disorders:

Rare: palpitation, hypotension.

Inform your medical doctor about the above mentioned adverse effects It besides the adverse reactions listed here you notice other unusal symptoms, inform on it to your doctor or pharmacist.

OVER – DOSAGE

No data concerning overdose are available. In over-dosage case, patient needed tightly critical care supervision, and symptomatic treatment and adjuvant care.

Suggested measures include emesis and/or gastric lavage.

STORAGE: Store at 250C – 300C.

Keep out of the reach of children.

SPECIFICATION: Manufacturer specification.

SHELF LIFE: 24 months from the manufacturing date.

DO NOT USE LATER THAN THE DATE OF EXPIRY

Read carefully  all of this package insert before using No Spa. keep this leaflet. You may need read it again. If you have any further questions, ask your doctor or your pharmacist, No Spa has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. It any of the safe effects gets serious,  listed in this leaflet, please tell your doctors or if you notice any side effects not  pharmacists.

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3 following good foods for the fetus http://healthca.info/2016/10/07/3-following-good-foods-fetus/ http://healthca.info/2016/10/07/3-following-good-foods-fetus/#respond Fri, 07 Oct 2016 16:59:42 +0000 http://healthca.info/?p=1431 3 following good foods for the fetus, especially the development of the brain. Abstinence after childbirth Prevent mastitis effectively while breastfeedin Food beneficial bacteria and polyunsaturated fatty acids PUFA good for both mother and child Polyunsaturated fatty acids (PUFA) and beneficial bacterial food is proven to help reduce the risk of mother elected allergies. The […]

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3 following good foods for the fetus, especially the development of the brain.

Abstinence after childbirth

Prevent mastitis effectively while breastfeedin

Food beneficial bacteria and polyunsaturated fatty acids PUFA good for both mother and child

Polyunsaturated fatty acids (PUFA) and beneficial bacterial food is proven to help reduce the risk of mother elected allergies. The scientists said that infants should be receiving the resident gut bacteria in the birth process.

It’s like a smaller ecosystem contains many microorganisms that help strengthen the immune system. In addition, beneficial bacteria food also supports the production of beneficial bacteria in the body mothers help combat pathogens.

good foods for the fetus

Flaxseed or flaxseed oil to help both mother and child resistance increases during pregnancy

PUFA bring utilities to improve the ability to adapt to the peripheral elements of the body. The PUFA-rich foods include flaxseed oil and walnut oil. Mushroom milk kefir and yogurt, the bacteria provide many benefits.

Spices

Spices is also good foods for the fetus. If you give up some favorite spices for fear of affecting the fetus, then this is probably not good news. Recent studies show that babies tend to eat more if mothers eat much before the food has flavor like vanilla or garlic.

The child’s brain development depends on the type of flavor when they want to learn about the new food.

Choline

Choline is an important nutrient good foods for the fetus similar to Vitamin B, and often are lumped together in a group, as a member of the vitamin B complex (vitamin B-complex). The body only produce very small amounts of choline; therefore, the use of choline-rich foods have important implications.

During pregnancy, pregnant mothers are often advised to select foods rich in iron, calcium and folate. Some functional foods to supplement this nutrient. However, according to recent statistics in women who have high income, they often enough choline supplementation.

Choline is an important link in the development of the fetal brain. Eat tofu, beef chops, eggs for more choline. Should consume about 450 mg choline / day during pregnancy and 550mg / day for breastfeeding.

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MEPRAZ Active ingredient ( Omeprazole 20 mg ) http://healthca.info/2016/10/07/mepraz-active-ingredient-omeprazole-20-mg/ http://healthca.info/2016/10/07/mepraz-active-ingredient-omeprazole-20-mg/#comments Fri, 07 Oct 2016 16:21:56 +0000 http://healthca.info/?p=1426 Drug MEPRAZ have composition Omeprazole 20 mg, treat of for Gastric ulcer, Gastroesophageal Reflux Disease, Short-term treatment (4-8 weeks) of severe erosive esophagitis, symptomatic gastroesophageal reflux disease Maalox indication treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia Pepsane indicated for the treatment of stomach ache. Pepsane : oral gel – sachets Air-X therapeutic indications accumulation […]

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Drug MEPRAZ have composition Omeprazole 20 mg, treat of for Gastric ulcer, Gastroesophageal Reflux Disease, Short-term treatment (4-8 weeks) of severe erosive esophagitis, symptomatic gastroesophageal reflux disease

Maalox indication treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia

Pepsane indicated for the treatment of stomach ache. Pepsane : oral gel – sachets

Air-X therapeutic indications accumulation of gas in the gastrointestinal tract

COMPOSITION: Each MEPRAZ capsule contains:

Active ingredient: Omeprazole 20 mg

DOSAGE FORM: Capsule (as enteric coated granules).

MEPRAZ Active ingredient - Omeprazole 20 mg

PACKAGING SIZE

– Box of 5 strips of 4 capsules

– 1 strip of 4 capsules in a strip-pack.

PROPERTIES

Mechanism of Action: MEPRAZ belongs to a new class of antisecretory compounds which inhibits enzyme H+/K+ ATPase (the proton pump) of the gastric mucosal cells. Its mechanism differs from anticholinergic or H2 histamine antagonistic agents. MEPRAZ combines with enzyme H+/K+ ATPase system and blocks the final step of acid production. This effect leads to inhibition of both basal acid secretion and stimulated acid secretion which are caused by stimulus of unknown etiology.

Anti-secretory Activity: After oral administration, the onset of the antisecretory effect of MEPRAZ occurs within 1h, with the maximum effect occurring within 2 hours. The inhibition of secretion is about 50% of maximum at 24 hours and the duration of inhibition lasts up to 72 hours. The anti-secretory effect thus lasts far longer than would be expected from the very short (less than 1h) plasma half-life, apparently due to prolonged binding to the parietal H+/K+ ATPase enzyme. When the drug is discontinued, secretory activity returns gradually over 3-5 days. The Inhibitory effect of MEPRAZ on acid secretion increases with repeated once-daily dosing, reaching a plateau after 4 days.

Pharmacokinetics:

Absorption

Absorption is rapid, with peak plasma levels of omeprazole occurring within 0.5 to 3.5 hours. Peak plasma concentrations of omeprazole and AUC are approximately proportional to doses up to 40 mg. Absolute bioavailability (compared with intravenous administration) is about 30-40% at doses of 20-40 mg, due in large part to presystemic metabolism. In healthy subjects the plasma half-life is 0.5 to 1 hour, and the total body clearance is 500-600 ml/min. Distribution: Protein binding is approximately 95%.

Metabolism:

Omeprazole 20mg is extensively metabolized by the cytochrome P450 (CYP) enzyme system.

Excretion: The majority of the dose (about 77%) was eliminated in urine as metabolites. Little if any unchanged drug was excreted in urine.

INDICATIONS

– Short-term treatment of active duodenal ulcer (MEPRAZ should not be used as maintenance therapy for treatment of patients with duodenal ulcer disease).

– Gastric ulcer.

– Gastroesophageal Reflux Disease (GERD):

– Short-term treatment (4-8 weeks) of severe erosive esophagitis (grade 2 or above) which has been diagnosed by endoscopy.

– Short-term treatment (4-8 weeks) of symptomatic gastroesophageal reflux disease (esophagitis) poorly responsive to customary medical treatment, usually including an adequate course of a histamine baroceptor antagonist.

– Long-term treatment of pathological hypersecretory conditions (Zolllnger-Ellison syndrome, multiple endocrine adenomas).

DOSAGE & ADMINISTRATION

– Short-Term Treatment of Active Duodenal Ulcer: The recommended adult oral dose is 20 mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

– Gastric ulcer: 20mg once daily tor 4 – 8 weeks.

– Severe Erosive esophagitis or poorly Responsive Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose is 20 mg daily for 4 to 8 weeks.

– Pathological Hypersecretory Conditions: The recommended adult oral starting dose is 60 mg once a day.

Doses should be adjusted to Individual patient needs and should continue for as long as clinically responses.

Doses up to 120 mg T.I.D have been administered. Daily dosage of greater than 80 mg should be administered in divided doses.

– No dosage adjustment is necessary for patients with renal impairment, hepatic dysfunction or tor the elderly.

– MEPRAZ should be taken before eating.

– MEPRAZ capsules should not be opened, chewed or crushed. It should be swallowed whole.

CONTRAINDICATIONS

– Hypersensitivity to any component(s) ot drug.

– MEPRAZ should not be used in pregnant women.

ADVERSE REACTIONS

MEPRAZ is well tolerated. Its adverse reactions occur rarely: nausea, headache, diarrhea, constipation, flatulence and skin rashes.

INFORM YOUR DOCTOR IN CASE OF ANY ADVERSE REACTION RELATED TO DRUG USE

WARNING

– Symptomatic response to MEPRAZ therapy does not preclude the presence of gastric malignancy diseases.

– The breast-feeding of infants should be discontinued in mothers receiving MEPRAZ.

DRUG INTERACTIONS

-The absorption of some drugs might be altered due to the decreased intragastric acidity: the absorption of Ketoconazole will decrease during MEPRAZ treatment.

– MEPRAZ is metabolised in the liver through cytochrome P450. it can prolong the elimination of Diazepam. Warfarin and Phenyltoin. However, concomitant treatment with MEPRAZ does not change the blood concentration of these drugs.

– Plasma concentrations of MEPRAZ and Clarithromycin are increased during concomitant administration.

– No interaction with food or concomitantly administered antacids has been found.

OVERDOSE

Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.

STORAGE: Store at temperature below 30°C. Avoid direct sunlight and moisture.

SPECIFICATIONS USP.

EXPIRY DATE: 30 months from the manufacturing date.

Keep out of reach of children Read the package insert carefully before use Ask your doctor for further information Use upon doctor’s prescription only

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ATARAX 25 ( Hydroxyzine hydrochloride 25mg ) http://healthca.info/2016/10/06/atarax-25-hydroxyzine-hydrochloride-25mg/ http://healthca.info/2016/10/06/atarax-25-hydroxyzine-hydrochloride-25mg/#respond Thu, 06 Oct 2016 15:06:03 +0000 http://healthca.info/?p=1421 Drug ATARAX have composition Hydroxyzine hydrochloride 25mg, indicated for the symptomatic treatment of pruritus, the symptomatic treatment of anxiety in adults, the premedication before surgery Alpha Choay indications enzymatic anti-oedema and anti-inflammatory: soft tissue injuries Medrol 4 mg indication for Rheumatic Disorders, Dermatologic Diseases, Allergic States Conposition EachFilm-coated tablet contains 25mg of hydrochloride Exciprents: Lactose […]

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Drug ATARAX have composition Hydroxyzine hydrochloride 25mg, indicated for the symptomatic treatment of pruritus, the symptomatic treatment of anxiety in adults, the premedication before surgery

Alpha Choay indications enzymatic anti-oedema and anti-inflammatory: soft tissue injuries

Medrol 4 mg indication for Rheumatic Disorders, Dermatologic Diseases, Allergic States

Conposition

EachFilm-coated tablet contains 25mg of hydrochloride

Exciprents: Lactose monohydrate, Microcrystamine cellulose. Magnesium stearate. Collcidal anhydrous silica, Opadry Y-1-7000 White (contains Titanium dioxide El7l).HP,M.C 29105cP,Macrogol 400)

ATARAX 25 - Hydroxyzine hydrochloride 25 mg

PHARMACEUTICAL FORM

White, oblong . film-coated tablet with a bisect line.

PACK SIZE

Box of 1 blister of 30 film-coated tablets.

INDICATIONS

ATARAX ( Hydroxyzine ) is indicated for

– the symptomatic treatment of anxiety in adults,

– the symptomatic treatment of pruritus,

– the premedication before surgery.

DOSAGE AND ADMINISTRATION

Route of Administration

For oral use

Adults:

– The symptomatic treatment of anxiety: 50 mg/day in 3 separate administrations of 12.5-12.5- 25 mg; in more severe cases doses up to 300 mg/day can be used.

– The symptomatic treatment of pruritus: starting dose of 25mg at night, to be followed if necessary with doses up to 25 mg three or four times daily.

– The premedicaiion before surgery: 50 to 200 mg/day in 1 or 2 administrations: single administration 1 hour before surgery, which may be preceded by 1 administration mg night before anesthesia.

The maximum single dose in adults should not exceed 200 mg whereas the maximum daily dose should not exceed 300 mg.

Children (from 12 months):

– The symptomatic treatment of pruritus:

– From 12 months to 6 years old: 1 mg/kg/day up to 2.5 mg/kg/day in divided doses.

– Over 6 years old: 1 mg/kg/day up to 2 mg/kg/day in divided doses.

– The premedication before surgery: single administration of 1 mg/kg 1 hour before surgery, which may be preceded by 1 mg/kg the night before anesthesia.

Dosage adjustments

ATARAX should be adapted within mg recommended dosage range, according to mg patient’s response.

In mg elderly, it is advised to start with half mg recommended dose due to prolonged action.

In patients with hepatic dysfunction. it is recommended to reduce mg daily dose by 33%.

Dosage should be reduced in patients with moderate or severe renal function impairment due to decreased excretion of its metabolite cetirizine.

CONTRAINDICATIONS

  1. Hydroxyzine is contraindicated in:
  2. patients with a history of hypersensitivity to hydroxyzine or any of mg excipients, to cetirizine. to other piperazine derivatives, to aminophymine, or to ethytedediammg,
  3. pregnancy and lactation (see Section Pregnaccy and Lactation),
  4. patients with porphyria,
  5. patients with pre-existing prolonged QT interval.

WARNINGS AND PRECAUTIONS

Convulsions

ATARAX should be administered cautiously in patients with increased potential for convulsions.

Children

Young children are more susceptible to develop adverse events related to the central nervous system (see Section Adverse Reactions). In children, convulsions have been more frequently reported than in adults.

Hydroxyzine anticholinergic effects

Because of its potential anticholinergic effects, hydroxyzine should be used cautiously in patients suffenng from glaucoma, bladder outflow obstruction, decreased gastrointestinal motility, myasthenia gravis, or dementia. Coadministration with CNS depressants

Dosage adjustments may be required if hydroxyzine is used simultaneously with otiier central nervous system depressant drugs or with drugs having anticholinergic properties (see Section Interactions).

Alcohol

the concomitant use of alcohol and hydroxyzine should be avoided (see Sectio Interactions).

Cardiac disorders

is needed in patients who have e known predisposing factor to csrdia arrhythmia, including electrolytes Imbalance (hypokalemia, hypomagnesaemia who have pre-existing heart disease, or who are concomitantly treated with’ potentially arrhythmogenic drug. In these patients use of alternative treatments j to be considered.

Elderly

In mg elderly, it is adwsed to start with half mg recommended dose due to a prolonged action.

Hepatic andrenalimpairment

Hydroxyzine dosage should be reduced in patients with hepatic dysfunction and in patients with moderate or severe renal impairment Excipient Lactose

Hydroxyzine film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, mg Lapp lactase deficiency or glucose- galactose malabsorption should not take the medicine.

INTERACTIONS

CNS depressants

Patients should be informed that hydroxyzine may potentiate mg effects of barbiturates, otherCNS depressants or drugs having antkhotinergic properties.

Alcohol

Alcohol also potentiates the effects of hydroxyzine.

Betahistine and anticholinesterase drugs

Hydroxyzine antagonises the effects of betahistine and anticholinesterase drugs, Tests results

The treatment should be stopped at least 5 days before allergy testing or methacholine bronchial challenge, to avoid effects on the test results.

Monoamine oxidase inhibitors

Simultaneous administration of hydroxyzine with monoamine oxidase Inhibitors should be avoided.

Epinephrine

Hydroxyzine counteracts the epinephrine pressor action.

Phenytoin

In rats, hydroxyzine antagonised the anticonvulsant action of phenytoin,

Cimetidine

Cimetidine 600 mg b.i.d. has been shown to increase the serum concentrations of hydroxyzine by 36% and to decrease peak concentrations of the metabolite cetirizine by 20%,

CYP2D6 substrates

Hydroxyzine Is an inhibitor of cytochrome P450 2D6 (Ki: 3.9 uM;1.7 pg/ml) and may cause at high doses drug-drug interactions with CYP2D6 substrates.

Effect on other drug metabolism

ATARAX ( Hydroxyzine ) has no inhibitory effect at 100 JJM on UDP-glucuronyi transferase isoforms 1A1 and 1A6 in human liver microsomes. It inhibits cytochrome P450 2C9/C10,2C19 and 3A4 isoforms at concentrations (ICH: 19 to 140   7 to 52 pg/ml) well above peak plasma concentrations. The metabolite cetirizine at 100 uM has no inhibitory effect on human liver cytochrome P450 (1A2, 2A6, 2C9/C10, 2C19, 2D6, 2E1 and 3A4) and UDP-glucuronyi transferase isoforms. Therefore, hydroxyzine is unlikely to Impair the metabolism of drugs which are substrates for these enzymes.

Potent inhibitors of liver enzymes

As hydroxyzine Is metabolised by alcohol dehydrogenase and CYP3A4/5. an increase in hydroxyzine blood concentrations may be expected when hydroxyzine is co-administered with other drugs known to be potent inhibitors of liver enzymes.

Potentially arrhythmogenic drugs

Co-administration of hydroxyzine with a potentially arrhythmogenic drug may increase the risk of QT prolongation and Torsade de Pointed.

PREGNANCY AND LACTATION

Fertility

There are no relevant data available.

Pregnancy

ATARAX is contraindicated during pregnancy (see Section Contraindications).

Animal studies have shown reproductive toxicity.

Hydroxyzine crosses the placental barrier leading to higher foetal than maternal concentrations.

To dale, no relevant epidemiological data are available relating to exposure to hydroxyzine during pregnancy.

In neonates whose mothers received hydroxyzine during late pregnancy and/or labour, the following events were observed immediately or only a few hours after birth: hypotonia, movement disorders including extrapyramidal disorders, clonic movements, CNS depression, neonatal hypoxic conditions, or urinary retention.

Lactation

ATARAX is contraindicated during lactation (see Section Contraindications). Breast-feeding should be stopped if hydroxyzine therapy is needed.

Cetirizine, the principal metabolite of hydroxyzine, is excreted in human milk. Although no formal studies have been performed on the excretion of hydroxyzine in human milk, severe adverse effects have been shown in breastfed newboms/infants of hydroxyzine treated mothers.

ABILITY TO PERFORM TASKS THAT REQUIRE JUDGEMENT, MOTOR OR COGNITIVE SKILLS

Alertness or reaction time may be impaired by hydroxyzine, therefore patients’ driving capacity or ability to use machines may be reduced. Concomitant use of hydroxyzine with alcohol or other sedative drugs should be avoided as it aggravated these effects.

ADVERSE REACTIONS

Undesirable effects are mainly related to CNS depressant or paradoxical CNS stimulation effects, to anticholinergic activity, or tohyperaensitivity reactions. Adverse reactions are ranked under headings of frequency using the following

Convention:

Very common  >=1/10

Common >= 1/100 to <1/10

Uncommon >=1/1000  To <1/100

Rare  >=1/10000 to <1/1000

Very rate   <1/10000

Notknown  (cannot be estimated from the avaliable data)

Clinical Trial Data

Nervous system disorders

Very common      somnolence

Common     headache

Uncommon-         dizziness, insomma.Adisturbance in attention

General disorders

Common     dry mouth

Uncommon constipation.        nausea

General disorders and administration site conditions

Common:    fatigue

Uncommon:         asthenia

Post Marketing Data

Immune system disorders

Notknown: hypersensitivity, anaphytactic shock

Psychiatric disorders

Notknown: agitation, confoston, disorientation. hallucination

Nervous system disorders

Not known: sedation, tremor, convulsions, dyskinesia

Eye disorders

Notknown: accommodation disorder, vision blurred

Cardiac disorders

Notknown: tachycardia, electrocardiogram         QT prolonged,

torsades depointes

Vasoular disorders

Notknown: hypotension

Respiratory, thoracic and mediastinal disorders Notknown   bronchospasm

Gastrointestinal disorders Notknown:        vomiting

Hepatobiliary disorders

Notknown: liver function tests abnormal

Skin and subcutaneous tissue disorders

Not known: pruritus, erythematous  rash, maculo-papular rash.

urticaria, dermatitis, angioneurotic oedema, hypeihidrosis, fixed drug eruption Renal and urinary disorders Notknown-  urinary retention

Genera/disorders and administration site conditions

Notknown  malaise, pyrexia

The following adverse reactions have been observed with cefirizine. the principal metabolite of hydroxyzine: thrombocytopenia, aggression, depression, tic, dystonia, paraestfiesta, oculogyric crisis, diarrhoea, dysuria, enuresis, asthenia, oedema, weight increased and could potentially occur with hydroxyzine.

OVERDOSAGE

Symptoms and signs

Symptoms observed after an important overdose are mainly associated with excessive anticholinergic load, Central Nervous System (CNS) depression or CNS paradoxical stimulation. They include nausea, vomiting, tachycardia, pyrexia, somnolence, impaired pupillary reflex, tremor, confusion, or hallucination. This may be followed by depressed level of consciousness, respiratory depression, convulsions, hypotension, or cardiac arrhythmia. Deepening coma and cardiorespiratory collapse may ensue.

Treatment

Airway, breathing and circulatory status must be closely monitored with continuous ECG recording and an adequate oxygen supply should be available. Cardiac and blood pressure monitoring should be maintained until the patient is free of symptoms for 24 hours Patients with altered mental status should be checked for simultaneous intake of other drugs or alcohol and should be given oxygen, naloxone, glucose, and thiamine if deemed necessary.

Norepinephrine or metarammol should be used if vasopressor Is needed Epinephrine should not be used.

Syrup of ipecac should not be administered in symptomatic patients or those who could rapidly become obtunded, comatose or convulsing, as this could lead to aspiration pneumonitis Activated charcoal may be left In the stomach but there are scant data to support its efficacy.

It is doubtful that haemodialysis or haemopertusion would be of any value.

There is no specific antidote.

Literature data indicate that in the presence of severe, life-threatening, intractable anticholinergic effects unresponsive to other agents, a therapeutic Inal dose of physostigmlne may be useful Physostigmine should not be used just to keep the patient awake If cyclic antidepressants have been coingested, use of physostigmine may precipitate seizures and intractable cardiac arrest Also avoid physostigmine in patients with cardiac conduction defects.

CLINICAL PHARMACOLOGY

Pharmacodynamics

Pharmacotherapeutic group

Antihistamines with sedative effect, Diphenytmethane derivatives

ATC Code

N05BB01

Mechanism of Action

ATARAX is a first generation antihistamine that crosses extensively the blood/brain bamer and has a high affinity for histaminic receptors Info the brain, thereby producing sedative-anxiolytic effects.

Pharmacodynamic effects

Anlihistamimc and bronchodilator activities have been demonstrated experimentally and confirmed dimcally. An antiemetic effect both by die apomorphine test and the verifoid test has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine at therapeutic dosage does not

increase gastric secretion or acidity and in most cases has mild antiseretory activity. Wheal an flare reduction have been demonstrated in adult healthy volunteers and in chilren after intradermal injections of histamine or antigens Hydroxyzine has also revealed its efficacy in relieving pryritus in various forms of urticaria, eczema and dermatitis.

Onset of action

The antihistaminic effect begins approximately affter 1 hour with oral pharmaceutical forms. The sedative effect starts after 30-45 minutes with tablets Hydroxyzine has a weak affinity for muscarinic receptors

Pharmacokinetics

Absorption

ATARAX is rapidly absorbed from (he gasmnteshnat tract The peon plasma level (Cmaxi ts reached approximately two hours after oral mutke Alter  doses of 25 mg end 50 mg . Cmax concentrations,respectively.

Following repeat administration once a day, concentrations are increased by 30%.

The oral of hydroxyzine with rasped to intramuscular

Distribution

Hydroxyzine is widely distributed in the body and generally more concentrate.! m the tissues foan m plasma The apparent volume is 7 to 16 l/kg in adults

Hydroxyzine enters the skin following oral Skin concentrations of hydroxyzine are higher than serum concentrations, following both Single and multiple administration. Hydroxyzine crosses the Wood-brain and placental barriers leading to higher foetal than maternal concentrations

Metabolism

Hydroxyzine is extensively metabolised The formation of the cetinzme. a carboxylic and metabolite (approximately 45% of the oral dose), is mediated by alcohol dehydrogenase. This metabotite mine significant penpheral Hl-antagonist properties The other metabolites identified include a N- deatkyiated metabolite, and an O-deefkyfated metabofife with a plasma half-life of 59 hours. These pathwaysare mediated principally by CYP3A4/5

Elimination

Hydroxyzine half-life In adults is approximately 14 hours (range 7 – 20 hrs) The apparent total body clearance calculated across studies is 13 Oily 0.8% of the dose is excreted unchanged in urine The major metabolite cetinzme is excreted mainly unchanged in urine (25% and 16 % of the hydroxyzine oral end IM dose, respectively).

Special patient populations

Children

The pharmacokinetics of ATARAX was evaluated in 12 paediatnc patients (mean 6.1 ± 4.6 yrs. 22.0 ± 12.0 kg) following a single oral dose of 0.7 mg/fcg. The apparent plasma clearance was approximately 2.5 times that in adults. The half- life was shorter than in adults It was approximately 4 hours m the 1 year-old patients and 11 hours in the 14 year-old-patrents. Dosage should be adjusted in paediatric population (see Section Dosage and Admministration)

Elderly

The pharmacokinetics of hydroxyzine was investigated in 9 healthy  subjeds(69.5i 3.7 years) following a single 0 7 mg/kg oral dose The elimination half-life of hydroxyzine was prolonged to 29 hours and the apparent volume of distribution was increased to 22.5 l/kg. It b recommended to reduce by half the daliy dose of hydroxyzine in elderly patients (see Section Oosege and Administration).

Renal impairment

The pharmacokinetics of ATARAX was studied in 6 severe ranatty impaired subjects (Creatinine clearance: 2417 ml/min) The extent ol exposure (AUC) to hydroxyzine was not altered in a relevant manner while that to toe carboxylic metabolite, cetinzme, was increased. This metabolite is not removed affluently by haemodialysis In order to avoid any important accumulation of the metabolite following multiple doses of hydroxyzme. the deity dose of hydroxyzine should be reduced in subjects with impaired renal function isee Sedan Dosage and administration).

Hepatic impairment

In subjects with hepatic dysfunction secondary to primary biliary emboss total body clearance was approximately 66% that of normal subtexts The half-life was increased to 37 hours and the serum concentrations of the carboryve metabolite, cetinzme. were higher than m young patients with a normal liver funchon. tarty dose or dose frequency should be reduced in patients with impaired lever function (see Section Dosage and administration)

SHELF LIFE: 60 months.

Do not use after expiry date indicated on the packaging

STORAGE: Keep at room temperature (150 C – 250 C), Keep container in the outer carton

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MEDROL 4 MG ( methylprednisolone 4 mg ) http://healthca.info/2016/10/06/medrol-4-mg-methylprednisolone-4-mg/ http://healthca.info/2016/10/06/medrol-4-mg-methylprednisolone-4-mg/#respond Thu, 06 Oct 2016 08:37:58 +0000 http://healthca.info/?p=1414 Drug Medrol 4 mg have composition methylprednisolone 4mg, Medrol 4 mg indication for Rheumatic Disorders, Dermatologic Diseases, Allergic States, Respiratory Disease, Neoplastic Diseases,  Gastrointestinal Diseases Alpha Choay indications enzymatic anti-oedema and anti-inflammatory : such as soft tissue injuries SPECIAL WARNING: Prescription only Read the instruction thoroughly before use Do not exceed the prescnbed dosage, if encountenng […]

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Drug Medrol 4 mg have composition methylprednisolone 4mg, Medrol 4 mg indication for Rheumatic Disorders, Dermatologic Diseases, Allergic States, Respiratory Disease, Neoplastic Diseases,  Gastrointestinal Diseases

Alpha Choay indications enzymatic anti-oedema and anti-inflammatory : such as soft tissue injuries

SPECIAL WARNING:

Prescription only

Read the instruction thoroughly before use Do not exceed the prescnbed dosage, if encountenng with any side effects, please consult physicians.

Consuit physician for further information Do not use the expired drugs Keep out of reach of children

MEDROL 4 MG - methylprednisolone 4 mg

1. NAME OF THE MEDICINAL PRODUCT MEDROL

2. QUALITATIVE AND QUANTITATIVE COMPOSITION :

Each tablet contains 4 mg or 16 mg of methylprednisolone.

3. PHARMACEUTICAL FORM

Tablet

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications of Medrol 4 mg

Endocrine Disorders

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice, synthetic analogs may be used in conjunction with mmalocorticoids where applicable, in infancy mineralocorticoid supplementation is of particular importance).

– Congenital adrenal hyperplasia

– Nonsuppurative thyroiditis

– Hypercalcemia associated with cancer

Nonendocrine Disorders

1. Rheumatic Disorders

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in.

– psonatic arthritis

– acute gouty arthritis

– rheumatoid arthritis, including juvenile

– post-traumatic osteoarthritis rheumatoid arthntis (selected cases may require low-dose maintenance therapy)

– ankylosing spondylitis

– synovitis of osteoarthritis

– acute ana subacute bursitis

– epicondylitis

– acute nonspecific tenosynovitis

2. Collagen Deeases

Dunng an exacerbation or as maintenance therapy in selected cases of:

– systemic lupus erythematosus

– polymyalgia rheumatics

– systemcdermatomyositis (polymyositis)

– giant cell arteritis

– acute rheumatic carditis

3. Dermatologic Diseases

– pemphigus

– mycosis fungoides

– bullous dermatitis herpetiformis

– severe psoriasis

– severe erythema multitorme (Stevens- Johnson syndrome)

– severe seborrheic dermatitis

exfoliative dermatitis

4. Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

– seasonal or perennial allergic rhinitis

– drug hypersensitivity reactions

– serum sickness

– contact dermatitis

– bronchial asthma

– atopic dermatitis

5. Ophthalmic Diseases

Severe acute and chronic allergic and inflammatory processes involving the eye and its adenexa such as.

– allergic corneal marginal ulcers

– allergic conjunctivitis

– herpes zoster ophthalmicus

– keratitis

– anterior segment inflammation

– chorioretinitis

– diffuse posterior uveitis and choroiditis

– optic neuritis

– sympathetic ophthalmia

– iritis and iridocyclitis

6. Respiratory Disease

– symptomatic sarcoidosis

– fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

– Leoffler’s syndrome not manageable

– aspiration pneumonitis by other means

– berylliosis

7. Hematologic Disorders

– idiopathic thrombocytopenic purpura

– erythroblastopenia (RBC anemia) in adults

– secondary thrombocytopenia in adults

– congenital (erythroid) hypoplastic anemia

– acquired (autoimmune) hemolytic anemia

8. Neoplastic Diseases

For palliative management of

– leukemias and lymphomas in adults

– acute leukemia of childhood

9. Edematous States

– to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, or the idiopathic type or that due to lupus erythematosus

10. Gastrointestinal Diseases

To tide the patient over a critical period of the disease in:

– ulcerative colitis

– regional enteritis

11. Nervous System

– acute exacerbations of multiple sclerosis

– management of edema associated with brain tumor

12. Organ Transplantation

13. Miscellaneous

– tuberculous meningitis with subarachnoid block or impending block when used concurrently with approphate antituberculous chemotherapy

– trichinosis with neurologic or myocardial involvement

MEDROL 16 MG - methylprednisolone 16 mg

4.2 Posology and Method of Administration

The initial dosage or methylprednisolone tablets may vary from 4 mg to 48 mg as methylprednisotone per day depending on the specific disease entity being treated In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. Clinical situations in which high-dose therapy may be indicated include multiple sclerosis (200 mg/day), cerebral edema (200-1,000 mg/ day), and organ transplantation (up to 7 mg/kg/day). If after a reasonable period of time there js a Jack of satisfactory clinical response, methylprednisolone tablets should be discontinued and the patient transferred to other appropriate therapy If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached It should be kept in mind that constant monitoring is needed in regard to drug dosage Included in toe situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of methylprednisolone tablets for a period of time consistent with the patient’s condition.

It should be emphasized that dosage requirements are variable and must be i ndividualized on the basis of the disease under treatment and the response of the patient.

Alternate Dav Therapy (ADT)

Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticosteroid is administered every other morning. The purpose of this mode of therapy is to provide a patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children,

4.3 Contraindications

Medrol 4 mg ( Methylprednisolone ) tablets are contraindicated in patients who have;

– systemic fungal infections

– known hypersensitivity to methylprednisolone tablets or to methylprednisolone. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids,

4.4 Special Warnings and Special Precautions for Use

Immunosuppressant Effects/lncreased Susceptibility to Infections

Corticosteroids may increase susceptibility to infection, may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic organisms, in any location in the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fetal course in non-immune children or adults on corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.

The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen, if corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy Discontinuation of corticosteroids may result in clinical remission The rote of corticosteroids in septic shock has been controversial, with early studies reporting both beneficial and detrimental effects. More recently, supplemental corticosteroids have been suggested to be beneficial in patients with established septic shock who exhibit adrenal insufficiency. However, their routine use in septic shock is not recommended and a systematic review concluded that short-course, high-dose corticosteroids did not support their use However, meta-analyses and a review suggest that longer courses (5-11 days) of low-dose corticosteroids might reduce mortality, especially in patients with vasopressor-dependent septic shock.

Immune System

Allergic reactions (e.g., angioedema) may occur.

Because rare instances of skin reactions and anaphylactic/anaphylactoid reactions have occurred in patients receiving corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.

Endocrine

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitaiy-adrenal (HPA) suppression (secondary adrenocortical insufficiency). The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency, time of administration, and duration of glucocorticoid therapy. This effect may be minimazed by the use of alternate-day theapy.

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

A steroid syndrome  seemingly initiated to adrenocortical insufficiency, may also occur Following abrupt discontinuance of glucocorticoids. This syndrome ntiudes Symptoms such as anorexia nausea vomiting, lethargy headache, fever,desquamation myalgia weigh loss and/for hypotension These effects are though to be due to toe sudden change m glucocorticoid concentration rather than to low cortcosterord levels

Because gtococortcotos can produce or aggravate Cushing’s syndrome, glucocorticoids should be avoided in patients with Cushing’s disease There is an enhanced effect of corticosteroids on patients with hypothyroidism

Metabolism and Nutrition

Including methylprednisolone. can increase blood glucose, worsen ore-exfshng diabetes and predispose those on long-term corticosteroid therapy to diabetes

Psychiatric

Psyche derangements may appear when corticosteroids are used, ranging from euphoria, reomma. mood swings personality charges, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids

Potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8 Undesirable Effects Psychiatric disorders) Symptoms typically emerge withm a few days or weeks of starting treatment Most reactions recover after either dose reduction or withdrawal although specific treatment may be necessary. Psychological effects have been reported upon withdrawal of corticosteroids: the frequency is unknown Patents/caregivers should be encouraged to seek medical attention if psychological symptoms develop in toe patient, especially if depressed mood or sudda) ideation is suspected Patients/caregivere should be alert to possible psydtitnc disturbances that may occur ether dunng or mmediatety after dose tapering/ withdrawal of systemic steroids

Nervous System

Corticosteroids should be used with caution in patients with seizure disorders. Corticosteroids should be used with caution m patients with myasthenia gravis (see myopathy statement in Muscutoskeletaf Effects section)

Although controlled drnreaf trials have shown corticosteroids to be effective in speeding toe resolution of acute exacerbations of mufcpfe sderosts they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (see section 4.2 Posdogy and Method of Administration)

There have been reports of epckirai lipomatosis in patients taking corticosteroids,

typkatiy with long-term use at high doses

Ocular

Corticosteroids should be used cautiously n patients with ocular herpes smptex because of posstie corneal perforation

Prolonged use of corticosteroids may produce posterior subcapsiiar cataracts and nudear cataracts (particularly in deldren), exophthalmos, or mcreased intraocular pressure, which may resuit m glaucoma with possible damage to toe optic nerves Establishment of secondary tagal and wrai infections of toe eye may also be enhanced in patients receiving glucocorticoids

Corticosteroid therapy has been associated with central serous chorioretinopathy, which may lead to retinal detachment

Cardiac

Adverse effects of glucocorticoids on toe cardiovascular system, such as dyslpidemia and hypertension may predispose treated patients wit existing carttiovascular nsk factors to additional cardiovascular effects, if high doses and prolonged courses are used Accordingly. corticosteroids should be employed in such patients and attention should be paid to nsk modification and additional cardiac it needed lowdose art altenute day therapy may redua tbe ncidena of complications n corticosteroid therapy

Systerrec corticosteroids should be used with caution, and only if necessary, in cases of congestive heart failure.

Vascular

Corticosteroids should be used with caution in patients with hypertension

Gastrointestinal

There is no universal agreement on whether corticosteroids per se are responsible for peptic ulcers encountered dunng therapy: however, glucocorticoid therapy may mask toe symptoms of peptic ulcer so tost perforation or hemorrhage may occur without significant par in combination with NSAIDs, toe risk of developing gastrointestinal ufcsre is increased

Corticosteroids should be used with caution in nonspecific ulcerative colitis if there is a probaotty of itnpending perforation, abscess or other pyogenic infection, diverticulitis fresh ntestinal anastomoses, or active or latent peptic ulcer

Hepatobiliary

High doses of corticosteroids may produce acute pancreatitis.

Musculoskeletal

An acute myopathy has been reported ‘with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e g . myasthenia grave), or in patients recerwig concomitant therapy with anticholinergics, such as neuromuscular blocking drugs fe.g. pancuronium). This acute myopathy is generafceti may involve ocular and respiratory musdes and may resuftfiquadnpa rests

Bcianons of creatine ksiase may occur. Clinical improvement or recovery after stopping require weeks to years

Osteoporosis is common but infrequently recognized adverse effect associated with a long-term of large Does

Renal and Urinary

Corteomrode should be used with caution in patients with renal insufficiency

Investigations

Average and large doses of hydrocortisone can cause elevation of blood pressure, salt and water  retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when use in large doses

Dietary salt restriction and potassium supplemention may be necessary all corticosteroids increase calcium excretion.

Injury, Poisoning and Procedural Complications

High doses of systemic corticosteroids should not be used for the treatment of traumati brain injury.

Other

Because complications of treatment with glucocorticoids are dependent on tbe size of tbe dose and tbe duration of treatment, a nsk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whetber daily or intermittent therapy should be used

The lowest possible dose of corticosteroid should be used to control the condition under treatment and when reduction in dosage is possible, the reduction should be gradual Aspmn and non-steroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids.

Pheochromocytoma crisis, which can be fetal, has been reported after administration of systemic corticosteroids Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation Use in Children

Growth and development of infants and children on prolonged corticosteroid therapy should be carefolty observed

Growth may be suppressed in children receiving long-term daily, divided dose glucocorticoid therapy and use of such regimen should be restricted to the most urgent indications. Alternate day glucocorticoid therapy usually avoids or minimizes this side effect (see section 4.2 Posology and Method of Administration, Alternate pay Therapy). Infants and children on prolonged corticosteroid therapy are at special risk from raised intracranial pressure

High doses of corticosteroids may produce pancreatitis in children.

4.5 Interaction with Other Medicaments and Other Forms of Interaction

Medrol 4 mg ( Methylprednisolone ) is a cytochrome P450 enzyme (CYP) substrate and is mainly metabolized by tbe CYP3A4 enzyme. CYP3A4 is tbe dominant enzyme of tbe most abundant CYP subfamily in the liver of adult humans. It catalyzes 6p-hydroxylation of steroids, tbe essential Phase I metabolic step for both endogenous and synthetic corticosteroids. Many other compounds are also substrates of CYP3A4, some of which (as well as other drugs) have been shown to alter glucocorticoid metabolism by induction (upregulation) or inhibition of the CYP3A4 enzyme.

CYP3A4 INHIBITORS – Drugs feat inhibit CYP3A4 activity generally decrease hepatic clearance and increase the plasma concentration of CYP3A4 substrate medications, such as methylprednisolone. In tbe presence of a CYP3A4 inhibitor, the dose of methylprednisolone may need to be titrated to avoid steroid toxicity CYP3A4 INDUCERS – Drugs that induce CYP3A4 activity generally increase hepatic clearance, resulting in decreased plasma concentration of medications that are substrates for CYP3A4. Co-administration may require an increase in methylprednisolone dosage to achieve the desired result

CYP3A4 SUBSTRATES – In the presence of another CYP3A4 substrate, tbe hepatic clearance of methylprednisolone may be affected, with corresponding dosage adjustments requited. It is possible that adverse events associated with the use of ether drug alone may be more likely to occur with co-administration.

NON-CYP3A4-MEDIATED EFFECTS – Other interactions and effects that occur with methylprednisolone are described in Table 1 below

Table 1 provides a list and descriptions of the most common and/or clinically important

drug interactions or effects with Medrol 4 mg ( methylprednisolone )

Table 1 . Important drug or substance interactions/effects with methylprednisolone

Drug Class or Type – DRUG or SUBSTANCE Interaction/Effect
Antibacterial

ISONIAZID

CYP3A4 INHIBITOR. In addition, there is a potential effect of methylprednisolone to increase the acetylation rate and clearance ofisoniazid.
Antibiotic, Antitubercular – RIFAMPIN CYP3A4 INDUCER
Anticoagulants (oral) The effect of methylprednisolone on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoaaulant effects.
Anticonvulsants – CARBAMAZEPINE CYP3A4 INDUCER (and SUBSTRATE)
Anticonvulsants

– PHENOBARBITAL

– PHENYTOIN

CYP3A4 INDUCERS
Anticholinergics – NEUROMUSCULAR BLOCKERS Corticosteroids may influence the effect of anticholinergics.

1)      An acute myopathy has been reported with tbe concomitant use of high doses of corticosteroids and anticholinergics, such as neuromuscular blocking drugs (see section 4.4 Special Warnings and Special Precautions for Use, Musculoskeletal, for additional information).

2)      Antagonism of the neuromuscular blocking effects of pancuronium and vecuronium has been reported in patients taking corticosteroids This interaction may be expected with all competitive neuromuscular blockers.

Anticholinesterases Steroids may reduce the effects of anticholinesterases in myasthenia gravis.
Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents mav be reauired
Antiemetic

–        APREPITANT

–        fosaprepitant

CYP3A4 INHIBITORS (and SUBSTRATES)

 

Antifungal

–        ITRACONAZOLE-KETOCONAZOLE

 

CYP3A4 INHIBITORS (and SUBSTRATES)

Aromatase inhibitors – AMIN OGLUTETHIMI DE Aminoglutethimide-incluced adrenal suppression may exacerbate  andocrine changes caused by prolonged glucocorticoid treatment

 

Calcium Channel Blocker

DILTIAZEM

CYP3A4 INHIBITOR (and SUBSTRATE)
Contraceptives (oral)

ETHINYLESTRADIOUlC N0RETHINDRONE

CYP3A4 INHIBITOR (and SUBSTRATE)
GRAPEFRUIT JUICE

 

CYP3A4 INHIBITOR
Immunosuppressant

–        CYCLOSPORINE

YP3A4 INHIBITOR (and SUBSTRATE)

1)      Mutual inhibition of metabolism occurs with concurrent

use of cyclosporine and methylprednisolone. which may increase the plasma concentrations of either or both drugs Therefore, it is possible that adverse events associated with the use of either drug alone may be more likely to occur  upon co-admmistration

2)      Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine

Immunosuppressant CYCLOPHOSPHAMIDE

tacrolimus

CYP3A4 SUBSTRATES

 

Macrolide Antibacterial

CLARITHROMYCIN

ERYTHROMYCIN

CYP3A4 INHIBITORS (and SUBSTRATES)
Macrotide Antibacterial TROLEANOOMYCIN CYP3A4 INHIBITOR
NSAIDs (non-steroidal anti-inflammatory drugs)

–        high-dose ASPIRIN (acetylsalicytic acid)

1)      There may be increased incidence of gastrointestinal bleeding and ulceration when corticosteroids are given with NSAIDs

2)      MethylprednlsoJone may increase the clearance of high- dose aspirin, which can lead to decreased salicylate serum levels. Discontinuation of methylprednisolone treatment can lead to raised salicylate serum levels, which could lead to an increased risk of salicylate toxicity

potassium-depleting agents When corticosteroids are administered concomitantly with potassium-depleting agents (i.e„ diuretics such as thiazides or loop diuretics), patients should be observed closely for development of hy pokalemia. There is also an increased risk of hypokalemia with concurrent use of corticosteroids with amphotericin B. xanthenes. or beta2 agonists
Antivirals

HIV-PROTEASE INHIBITORS

CYP3A4 INHIBITOR

CYP3A4 INHIBITORS (and SUBSTRATES)

1)      Protease inhibitors, such as indinavir and ritonavir, may increase plasma concentrations of corticosteroids

2)      Corticosteroids may induce the metabolism of HIV-inhibitors resulting in reduced plasma concentrations

 

4.6 Pregnancy and Lactation

Fertility

There is no evidence that corticosteroids impair fertility (see section 5.3 Preclinical Safety Data).

Pregnancy

Some animal studies have shown that corticosteroids, when administered to the mother at high doses, may cause fetal malformations, However, corticosteroids do not appear to cause congenital anomalies when given to pregnant women.

Despite animal findings, it would appear that the possibility of fetal harm is remote, if the drug is used during pregnancy. Adequate human reproductive studies have not been done with corticosteroids. Since there is inadequate evidence of safety in human pregnancy, this drug should be used in pregnancy only if dearly needed.

Some corticosteroids readily cross the placenta. One retrospective study found an increased incidence of low birth weights in infants bom of mothers receiving corticosteroids Infants born to mothers, who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency, although neonatal adrenal insufficiency appears to be rare in infants who were exposed in utero to corticosteroids.

There are no known effects of corticosteroids on tabor and delivery.

Cataracts have been observed in infanls bom to mothers undergoing long-term treatment with corticosteroids during pregnancy.

Lactation

Corticoids are excreted in breast milk. Corticosteroids distributed into breast milk may suppress growth and interfere with endogenous glucocorticoid production in nursing infants Since adequate reproductive studies have not been performed in humans with glucocorticoids, these drugs should be administered to nursing mothers only if the benefits of therapy are judged to outweigh the potential risks to the infant

4.7 Effects on Ability to Drive and Use Machines

The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as dizziness, vertigo, visual disturbances and fatigue are possible after treatment with corticosteroids, if affected, patients should not drive or operate machinery.

4.8 Undesirable Effects

Infections and infestations: Infection, Opportunistic infection Immune system disorders: Drug hypersensitivity (including Anaphylactic reaction and Anaphylactoid reaction), suppression of reactions to skin tests Endocrine disorders: Cushingoid, Hypopituitarism, Steroid Withdrawal syndrome Metabolism and nutrition disorders: Alkalosis hypokalaemic, Fluid retention, Glucose tolerance impaired, Increased appetite (which may result in Weight increased), increased requirements for insulin or oral hypoglycemic agents in diabetics. Metabolic acidosis, Sodium retention

Psychiatric disorders: Abnormal behaviour, Affective disorder (including Affect lability, Depressed mood. Euphoric mood, psychological dependence, Suicidal ideation), Anxiety. Confusional state, Insomnia, Irritability. Mental disorder. Mood swings. Personality change. Psychotic behaviour, Psychotic disorder (including Mania, Delusion, Hallucination, and Schizophrenia [aggravation of])

Nervous system disorders: Amnesia, Cognitive disorder. Convulsions, Dizziness. Headache, Intracranial pressure increased (with Papilloedema [Benign intracranial hypertension)), Epidural lipomatosis

Eye disorders’ Cataract subcapsular. Exophthalmos, Glaucoma, Centra! serous

chorioretinopathy

Ear and labymth disorders. Vertigo

CeraEac disorders Cardiac failure congestive (in susceptible patients)

Vascular itsorders Hypertension, Hypotension

Respiratory, thoracic and mediastinal disorders Hiccups

Gastrofotest/naf disorders Abdominal distension. Abdominal pain. Diarrhoea. Dyspepse.

Gastric haemorrhage Intestinal perforation. Nausea Oesophagitis Oseophagitis

ulcerative, Pancreatitis, Peptic ulcer (with possible Peptic ulcer perforation aid Peptic

ulcer haemorrhage)

Skin and subcutaneous tissue disorders: Angoedema, Eechymosis, Erythema, Hirsutism. Hyperhidrosis, Petechiae Pruritus, Rash. Skin atrophy. Skin striae. Urticaria Musculoskeletal and connective tissue disorders. Arthralgia. Growth retardation. Musde atrophy, Muscular weakness Myalgia Myopathy, Neuropathic arthropathy, Osteonecrosis, Osteoporosis. Pathologic fracture Reproductive system and breast disorders: Menstruation irregular Genera/disorders and admimsbabon site conditions: Fatigue Impaired beating, Malaise Investigations: Alanine aminotransferase increased. Aspartate aminotransferase increased, Blood alkaline phosphatase increased. Blood potassium decreased, Carbohydrate tolerance decreased, Intraocular pressure increased. Urine calcium increased Injury, poisoning and procedural complications Spinal compression fracture. Tendon rupture (particularly of the Achilles tendon)

4.9 Overdose

There is no clinical syndrome of acute overdosage with corticosteroids. Reports of acute tenacity and/or death following overdosage of corticosteroids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic. Medrol 4 mg ( Methylprednisolone ) is dialyzable.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Medrol 4 mg ( Methylprednisolone ) is a potent anti-inflammatory steroid. It has greater anti-inflammatory potency than prednisolone and less tendency than prednisolone to induce sodium and water retention. The relative potency of methylprednisolone to hydrocortisone is at least four to one.

5.2 Pharmacokinetic Properties

Methylprednisolone pharmacokinetics is linear, independent of route of administration. Absorotion.

Methylprednisolone is rapidly absorbed and the maximum plasma methylprednisolone concentration is achieved around 1.5 to 2 3 hours across doses following oral administration in normal healthy adults. The absolute bioavailability of methylprednisolone in normal healthy subjects is generally high (82% to 89%) following oral administration. Distnbution

Methylprednisolone is widely distributed into toe tissues, crosses the blood-brain barrier, and is secreted in breast milk, Its apparent volume of distribution is approximately 1,4 L/kg The plasma protein binding of methylprednisolone in humans is approximately 77%. Metabolism:

In humans, methylprednisolone is metabolized in the liver to inactive metabolites; the major ones are 20a-hydroxymethylpredni$ok>ne and 20^-hydroxymethylprednisolone. Metabolism in tbe liver occurs primarily via the CYP3A4 enzyme For a list of drug interactions based on CYP3A4-mediated metabolism, see section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction Methylprednisolone. Like many CYP3A4 substrates, may also be a substrate for toe ATP- binding cassette (ABC) transport protein p-glycoprotein. influencing tissue distribution and interactions with other methanes Elimination

Tbe mean elimination half-life for total methylprednisolone is in toe range of 1.8 to 5.2 hours Total clearance is approximately 5 to 6 mL/min/kg

No dosing adjustments are necessary in renal feilure Methylprectoisotone is hemodiatyzabte.

5.3 Preclinicai Safety Data

Tbe nondmical database, m combination with evidence of safety gleaned from years of cincal experience and posi-mafketmg survetiance. supports tbe safety of methylprednisolone tablets as a potent anti inflammatory agent in shot-term inflammatory disorders.

Based on conventional studies of safety pharmacology, repeated-dose toxicity to mice, rats, rabbits, and dogs using intravenous, intraperitoneal, subcutaneous, intramuscular, and oral routes of administration. no unexpected hazards were identified Tbe toxidties seen in tbe repeated-dose studies are those expected to occur with continued exposure to exogenous adrenocortical steroids Carcinoaenic potential

Longterm studies n animals have not been performed to evaluate carcinogenic potential, as toe drug is indicated for short-term treatment only

There was no evidence of a potential for genetic and chromosome mutations when tested in limited studies performed in bacterial and mammalian cells Reproduce toaotv-

Reproductive fertility studies in animals have not been performed to evaluate specifically the potential of impairment of fertility. There is no evidence that corticosteroids cause impair of fertility.

Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. In animal reproduction studies, glucocorticoids such as methylprednisolone have been shown to induce malformations (deft palate, skeletal malformations) and intra-utenne growth retardation.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Medrol 4 mg: Lactose, com starch, dried com starch, sucrose, calcium stearate. Medrol 16 mg: Lactose, com starch, sucrose, calcium stearate, liquid paraffin

6.2 Incompatibilities Notappticable

6.3 Shelf-life

Medrol 4 mg 36 months since manufacturing date Medrol 16 mg 24 months since manufacturing date

6.4 Special Precautions for Storage Store below 30C

6.5 Nature and Contents of Container

Medrol 4 mg Box of 3 blisters x 10 tablets Medrol 16 mg Box of 3 blisters x 10 tablets Specification: Manufacturer’s Manufacturer.

 

 

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Ginkor FORT – Ginkgo biloba extract, heptaminol and troxerutin http://healthca.info/2016/10/05/ginkor-fort-ginkgo-biloba-extract-heptaminol-troxerutin/ http://healthca.info/2016/10/05/ginkor-fort-ginkgo-biloba-extract-heptaminol-troxerutin/#respond Wed, 05 Oct 2016 14:46:50 +0000 http://healthca.info/?p=1410 Drug Ginkor FORT have composition 24% heterosides Ginkgo and 6% Ginkgolides-bilobalide, Heptaminol chlorhydride, Troxerutine. Indication acute haemorrhoidal, venolymphatic insufficiency Daflon 500mg indications venous circulation disorders : swollen legs, acute hemorrhoidal FORM AND PRESENTATION Capsule Box of 30 blistered capsules COMPOSITION For a capsule of 0,625g – Active ingredients: Standardized Ginkgo biloba extract containing 24% heterosides […]

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Drug Ginkor FORT have composition 24% heterosides Ginkgo and 6% Ginkgolides-bilobalide, Heptaminol chlorhydride, Troxerutine. Indication acute haemorrhoidal, venolymphatic insufficiency

Daflon 500mg indications venous circulation disorders : swollen legs, acute hemorrhoidal

FORM AND PRESENTATION

Capsule Box of 30 blistered capsules

COMPOSITION

For a capsule of 0,625g

– Active ingredients:

Standardized Ginkgo biloba extract containing

24% heterosides Ginkgo and 6% Ginkgolides-bilobalide        0,014 g

Heptaminol chlorhydride (DCI)   0,300 g

Troxerutine (DCI)    0,300 g

– Excipients: Magnesium Stearate, silicic acid.

Ginkor FORT - Ginkgo biloba extract, heptaminol and troxerutin

PHARMACOLOGICAL PROPERTIES

Egb 761 (Standardized Ginkgo biloba Extract):

– Enhances venous vascular tone, counters the hyper- permeability of vessel walls, strengthens their resistance, prevents plasma leakage and edematous effect.

– Effects on cellular metabolism (improve cell respiration, production of ATP).

– Inhibiting the production of free radicals. Scavenging free radicals. Preventing lipo- peroxidation. Protecting collagen micro-fibrils.

Heptaminol chlorhydrate: Used in the treatment of cardiovascular disorders.

Troxerutine:

–        Is an antioxidant.

–        Improve capillary function by reducing abnormal leakage.

–        Has been given to relieve capillary impairment and venous insufficiency of the lower limbs, and for heamorrhoids.

The maximum contractile effect of Heptaminol was increased 20- 30% in the presence of ECb. With the combination of 3 active ingredients, Ginkor Fort is a venotonic and vasculoprotector, increases venous tonicity, vessel resistance, decreases their permeability and protects collagen fibers.

These effects are accompanied by a local inhibitory activity against several pain-inducing mediators (histamine, bradykinin, serotonin), lysosomal enzymes and free radicals capable of inducing inflammatory processes and degradation of collagen fibers. Ginkor Fort promotes venous return to the right side of the heart due to Heptaminol chlohydrate in the formula.

PHARMACOKINETIC PROPERTIES

Considering the active ingredients associated, no pharmacokinetic study has been performed in human.

THERAPEUTIC INDICATIONS OF Ginkor FORT

– Treatment of symptoms related to the venolymphatic insufficiency (heavy legs, pain, primodecubitus restless legs,…).

– Treatment of functional signs related to the acute haemorrhoidal attack.

DOSAGE AND ADMINISTRATION

– Venolymphatic insufficiency: 2 capsules per day, one in the morning and one in the evening.

– Acute haemorrhoidal attack: loading treatment 3 to 4 capsules per day during 7 days, at mealtimes.

CONTRAINDICATION

Those related to heptaminol hyperthyroidism, association with MAOIs (monoaminoxydase inhibitors) because of the risk of hypertension.

PRECAUTIONS

– Due to the presence of Heptammol, observation of blood pressure at the start of treatment is recommended in all sublets suffering from severe arterial hypertension.

– Acute haemorrhoidal attack administration of the product does not dispense from specific treatment of other anal diseases. The treatment must be short. If symptoms do not resolve rapidly, a haemorrhoidal examination should be carried out and the treatment should be reconsidered.

– Venolymphatic insufficiency: this medicinal product is fully effective when used in combination with a healthy lifestyle:

+ Avoid exposure to the sun and heat, standing for long periods, and excess body weight.

+ Prolonged walking and wearing of special compression stockings promote venous circulation.

– To sportsmen: this product contains an active ingredient (heptaminol) which is likely to induce positive signs when doping tests are carried out.

In case of doubt, do not hesitate to ask for the advice of your doctor of pharmacist.

OVERDOSACE

In case of overdosage of Ginkor FORT, hospitalization of the patient is advised for careful surveillance of blood pressure and heart rate.

PREGNANCY AND LACTATION

Experiments in animals have failed to reveal any teratogenic effects. In humans, the risk is unknown since there is no study within the first quarter of pregnancy. However, no malformative effect has been reported to date.

Lactation: It is not known whether the drug is excreted in human milk, so it is not advised to administrate the drug during lactation.

DRUG INTERACTIONS, INCOMPATIBILITIES

The simultaneous administration of monoaminoxydase inhibitors (MAOI) should be avoided: risk of hypertensive episode due to the presence of heptaminol.

ADVERSE EFFECTS

None.

STORAGE CONDITION AND SHELF LIFE : To be stored in a dry place below 30 C.

Shelf life Ginkor FORT 2 years.

Do not exceed the date plainly indicated on the packaging.

Keep out of reach of children.

For further information, please consult your doctor of pharmacist.

Country of origin: France

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IXIFAST 200 ( Cefixime 200 mg ) http://healthca.info/2016/10/04/ixifast-200-cefixime-200-mg/ http://healthca.info/2016/10/04/ixifast-200-cefixime-200-mg/#respond Tue, 04 Oct 2016 15:35:18 +0000 http://healthca.info/?p=1407 Drug Ixifast 200 have composition Cefixime 200 mg, Ixifast is indicated in the treatment of the following infections: Otitis media- Caused by H. Influenzae,  Acute bronchitis, Uncomplicated urinary tract infection Emycin 250 DHG treatment of respiratory tract infections, gastrointestinal tract infections ROVAS 1.5M IU treatment of Lower, Upper respiratory tract infections : otitis, sore throat DESCRIPTION: […]

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Drug Ixifast 200 have composition Cefixime 200 mg, Ixifast is indicated in the treatment of the following infections: Otitis media- Caused by H. Influenzae,  Acute bronchitis, Uncomplicated urinary tract infection

Emycin 250 DHG treatment of respiratory tract infections, gastrointestinal tract infections

ROVAS 1.5M IU treatment of Lower, Upper respiratory tract infections : otitis, sore throat

DESCRIPTION:

Ixifast is the brand name of cefixime a broad-spectrum third generation oral cephalosponn, Cefixime is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentration. Cefixime is also highly stable in the presence of beta- ladamase enzyme. As a result many organisms resistant to penicillin and some cephalosporin due to the presence of beta-lactamase may be susceptible to cefixime.

IXIFAST 200 - Cefixime 200 mg

COMPOSITION:

Ixifast 200 : Each capsule contains cefixime trihydrate BP equivalent to cefixime 200 mg.

Excipients are Lactose Anhydrous & Magnesium Stearate.

“Carefully read the instruction before use, ask your doctor for further information”

INDICATION:

Ixifast 200 is indicated in the treatment of the following infections.

Otitis media- Caused by H. Influenzae (beta lactamase), Moraxelia catarrhalis mostly beta-lactamase positive Streptococcus pyogenes.

Acute bronchitis & exacerbation of chronic bronchitis- Caused by Strep. pneumonias & H. Influenzae (beta lactamase positive & negative strains) Pharyngitis & tonsillitis- Caused by Streptococcus pyogenes.

Uncomplicated urinary tract infection- Caused by E. coli, Proteus mirabillis. Uncomplicated gonorrhoea (cervical / urethral) – Caused by Neisseria gonorrhoea (penicillinase and non penicillinase producing strains)

DOSAGE AND ADMINISTRATION:

Adult: The recommended dose is 400 mg daily. This may be given as a 400 mg capsule daily or as 200 mg capsule every 12 hours for 7 to 14 days depending on the severity of disease.

Uncomplicated gonococcal (cervical / urethral) infection: A single dose of 400 mg is recommended.

Children: >6 months : 8 mg/ kg daily in 1-2 divided doses.

6 months – 1 year: 75 mg daily

1 – 4 years   : 100 mg daily

5 – 10 years   : 200 mg daily

> 10 years  : same as adult dose

PRECAUTION & WARNING:

The possibitity of the emergence of resistant organisms which might result in over growth should be kept in mind, particularly during prolonged treatment in such use, careful observation of the patient is essential. If super infection occurs during therapy appropriate measures should be taken. Dose adjustment in renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis, should be monitored carefully. It should also be used with caution in patient with gastrointestinal disease, particularly colitis.

CONTRAINDICATION:

It is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

SIDE EFFECTS:

Side effects are usually mild and transient in nature. The following adverse reactions have been reported – diarrhoea, loose stool, abdominal pain, dyspepsia, nausea & vomiting. In some cases severe pseudomembranous colitis were identified which occurred dunng or after therapy Besides, skin rash, urticaria, drug fever, pruritus, headache, dizziness, prolongation prothrombin time, elevation of SGPT, SGOT transient elevation of BUN or creatinine.

Inform your doctor in case of any adverse reactions related to drug use”

DRUG INTERACTIONS:

Carbamazepine: Elevated carbamazepine levels have been reported

USE IN PREGNANCY & LACTATION:

Cefixime is pregnancy category-B drug. There are no adequate & well- controlled studies in pregnant women. So it should be used during pregnancy only if clearly needed. It is not known whether it appear in breast milk Consideration should be given to discontinuing temporarily nursing during treatment with this drug.

SPECIFICATION: In house SHELF LIFE: 3 years

STORE: Store at a cool & dry place below 30°C.

Keep out of reach of children.

PACK SIZE: Box containing 1 x 10’s capsule in Alu-Alu blister.

Manufactured by: Navana Pharmaceutical Ltd.

Factory: Rupganj, Narayanganj, Bangladesh Head Office: 3/C Purana Paltan, Dhaka-1000, Bangladesh

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FORLAX Powder for oral solution http://healthca.info/2016/10/02/forlax-powder-oral-solution/ http://healthca.info/2016/10/02/forlax-powder-oral-solution/#comments Sun, 02 Oct 2016 09:45:15 +0000 http://healthca.info/?p=1402 Drug FORLAX have composition Macrogol, Flavour, Saccharin sodium, FORLAX Symptomatic treatment of constipation in adults and children aged 8 years and above Phosphalugel is an antacid. It reduces the acidity of the stomach Duphalac indications Constipation, Where soft stool is considered of medical benefit QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 10g of macrogol 4000. […]

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Drug FORLAX have composition Macrogol, Flavour, Saccharin sodium, FORLAX Symptomatic treatment of constipation in adults and children aged 8 years and above

Phosphalugel is an antacid. It reduces the acidity of the stomach

Duphalac indications Constipation, Where soft stool is considered of medical benefit

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 10g of macrogol 4000.

Macrogol 4000   10.00g

Flavour (orange – grapefruit)  0.15g

Saccharin sodium    0.017g

Per sachet of 10.17g

+ Composition of the orange-grapefruit flavour

Orange and grapefruit oils, concentrated orange juice, citral. acetaldehyde, linalol, ethyl butyrate, alpha terpincol, octanal,beta gamma hexenol. maltodextrine. gum arabic, sorbitol, BHA (E320) and sulphur dioxide (E220).

FORLAX Powder for oral solution

PHARMACEUTICAI FORM

Powder for oral solution in sachet.

Single dose sachet containing an almost white powder with an odour and taste of orange grapefruit

INDICATIONS

Symptomatic treatment of constipation in adults and children aged 8 years and above. An organic disorder should have been niled out before initiation of treatment. FORLAX l0g should remain a temporary treatment of constipation adjuvant to appropriate hygienic and dietary measures, with a maximum 3-month treatment course in children. If symptoms pasist despite hygienic and dietary measures, an underlying cause should be suspected and treated

METHOD OF ADMINISTRATION

l to 2 sachets per day, preferably utken asti single dose in the morning. Each sachet should be dissolved in a glass of water just before use.

The effect of FORLAX becomes apparent within 24 to 48 hours after its administration.

In children, treatment should not exceed 3 months in the lack of clinical data more than 3 months.Treatment-induced restoration of bowel movements will be maintained by hygienic and dietary measures.

The daily dose should be adapted according to the clinical effects and may range from one sachet every other day (especially in children) up to 2 sachets a day.

CONTRAINDICATIONS

– severe inflammatory bowel disease (such as ulcerative colitis, Crohn’s disease) or toxicitiegicolon, associated with symptomatic stenosis,

– digestive perforation or risk of digestive perforation,

– ileus or suspicion of intestinal obstruction,

– painful abdominal syndromes of indeterminate cause.

– hypersensitivity to macmgol (polyethylene glycol) or to any of the excipients.

SPELTAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Warning

The treatment of constipation with any medicinal product is only an adjuvant to a healthy lifestyle and diet, for example: increased intake at liquids and dietary fibre

– appropriate physical activity and rehabilitation of the bowel reflex.

Patients with hereditary problems of fructose intolerance should not take this medicinal product.

Due to the presence of sulphur dioxide, it may rarely cause severe hypersensitivity reactions and bronchospasm.

In case of diarrhoea, caution should be exercised in patients prune for disturbances of water-electrolyie balance (e.g. elderly, patients with impaired hepatic ur renal function or patients taken diuretics) and electrolyte control considered

Precaution for you

Very rare cases of hypersensitivity reactions (rash, urticaria, oedema) have been reported with drags containing macmgol (polyetliylene glycol). Exceptional tees of anaphy lactic shock have been reported.

FORI AX dose not contain a significant quantity of sugar or polyol and can he prescribed to diabetic patients or patients on a galactose-free

INTERRACTION WITH OTHER  MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Not applicable

PREGNANCY AND LACTATION

Pregnancy

Macrogol 4000 was not teratogenic in rats or rabbits

No effects during pregnancy are anticipated, since systemic exposure to FORLAX is negligible FORLAX can he used during pregnancy.

Lactation

No effects on the breast feeding newborn/infant are anticcipated since the sys temic exposure of the breast-feeding woman to macrogol 4000 is negligible. FORLAX can be used during breast feeding.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Not applicable

UNDESIRANLE EFFECTS

Adverse Drug Reactions are listed under headings of frequency using the folloing categories:

Very common (>=1/10): common (>=1/100 to < 1/10), incommon( (>=1/1000 to < 1/100); rare (>=1/10,000 to < 1/1000); very rare (<1/10 to < 1/10,000); unknown (cannot be estimated from the availanle data)

Adult population:

The undesirable effects listed in the table below has been reoirted during  clinical trials (including 600 adult atients) and post – marketing use

Generally, adverse reactions have been minor and transitory and have mainly concerned the gastrointestinal system:

System Organ Class Adverse reactions
Gastrointestinal disorders
Common Abdominal pain and/ or distension

Diarrhoea

Nausea

Uncommon Vomiting

Urgency to defecate Fecal incontinence

Metabolism and Nutrition Disorders
Unknown Electrolytes disorders (Hyponatremia, Hypokalaemia) and or dehydration, especially in elderly paiterns
Immune system disorders
Very rare Hypersensitivity reactions (Pruritus. Rash. Face oedema, Quincke oedema. Urticaria. Anaphylactic shock)

Paediatric population

The undesirabk effects Usted in the table below have been repotted during clinical trials including 147 children aged from 6 months to 15 years and post-marketing use. As in adult population, adverse reactions have generally been minor and transitory and have mainly concerned the gastrointestinal system:

System Organ Class Adverse reactions
Gastrointestinal disorders
Common Abdummal pain Diarrhoea
Uncommon Vomiting

Bloating

Nausea

Immune system disorders
Unknown | Hypersensitivity reactions

* Diarrhoea may cause perianal soreness

OVERDOSE

Overdose leads to diarrhoea which disappears when treatment is temporarily interrupted or the dosage is reduced.

Excessive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

Cases of aspiration have been reported when extensive volumes of polyethylene glycol and electrolytes were administered with nasogastric tube. Ncurologically impaired children who have ormotor dysfunction are particularly at risk of aspiration.

PHARMACODYNAMIC PROPERTIES

OSMOTIC LAXATIVE, ATC code: A06AD15

A: gastrointestinal tract and metabolism

High molecular weight (4000) macrogols (PEG) are long linear polymers which retain water molecules by means of hydrogen bunds. When

administered by the oral route, they lead to an increase in volume of intestinal fluids

The volume of unabsorbed intestinal fluid accounts tor the laxative properties of the solution.

PRECLINICAL SAFETY DATA

Toxicological studies in different species of animals did not reveal any sign of systemic or local gastrointestinal toxicity of macrogol 4000.

Macrogol 4000 had no teratogenic, mutagenic, nor carcinogenic effect, Potential drug interactions studies performed in rats on some.

NSAIDs, anticoagulants, gastric antisecretory agents, or on a hypoglycaemic sulfamide showrd the FORLAX did not interfere with gastrointestinal absorption of these compounds

PHARMACOKINETIC PROPERTIES

The pharmacokinetic data confirm that macrogol 4000 undergoes niether gastrointestinal resorption nor biotranformation following oral ingestion

SHELF LIFE: 3 years

STORAGE: stored below 300 C

NATURE AND CONTENTS OF CONTAINER

10,167 g of powder in signle dose sachet ( Paper/Aluminium/PE)

Box of 10,20, or 50 cachet.

Read the pack insert carefully before use. Ask Doctor or Pharmacist if need more information.

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Duphalac 667 g/l oral solution http://healthca.info/2016/10/01/duphalac-667-gl-oral-solution/ http://healthca.info/2016/10/01/duphalac-667-gl-oral-solution/#comments Sat, 01 Oct 2016 09:37:36 +0000 http://healthca.info/?p=1394 Duphalac is a clear, viscous, colourless to brownish yellow aqueous solution (liquid) for oral administration containing 667 g lactulose per 1000 ml. Duphalac oral solution does not contain any excipients, but may contain small amounts of related sugars (e.g. lactose, galactose, epilactose. fructose) derived from the route of synthesis. Phosphalugel is an antacid. It reduces […]

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Duphalac is a clear, viscous, colourless to brownish yellow aqueous solution (liquid) for oral administration containing 667 g lactulose per 1000 ml.

Duphalac oral solution does not contain any excipients, but may contain small amounts of related sugars (e.g. lactose, galactose, epilactose. fructose) derived from the route of synthesis.

Phosphalugel is an antacid. It reduces the acidity of the stomach

Pepsane is indicated for the treatment of stomach ache

Indications

– Constipation: regulation of the colonic physiological rhythm

– Where soft stool is considered of medical benefit (haemorrhoids, post colonic/anal surgery)

– Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma

Duphalac 667 g/l oral solution

Dosage and administration

You may take Duphalac oral solution diluted or undiluted, you also can use lactulose one dose daily or divide into two doses a day, using measuring cup.

Take your dose of lactulose in one swallow; do not hold the solution in your mouth for any length of time.

Your doctor will adjust the dosage according to your response to the medicine, if you have been prescribed a single daily dose, always take it at the same time of day, e.g. during breakfast.

During therapy with laxatives it is important for you to drink sufficient amounts of fluids f 1.5 – 2 litres, equal to 6-8 glasses) during the day.

For Duphalac in bottles the measuring cup may be used For Duphalac in 15 ml single dose sachets the comer of the sachet should be tom off and contents taken immediately.

Dosing in constipation or where soft stool is considered of medical benefit

Duphalac may be taken as a single daily dose or in two divided doses, for Duphalac in bottles the measuring cup may be used.

Based upon treatment response your doctor may adjust the starting dose to the maintenance dose after a few days. Several (2-3) days of treatment may be needed before treatment effect occurs.

Duphalac oral solution in bottles or 15 ml single dose sachets

Starting dose, daily Maintenance dose daily
Adults and adolescents 15 – 45 ml, corresponding to 1-3 sachets 15-30 ml, corresponding to 1-2 sachets
Children (7 – 14 years) 15 ml, corresponding to 1 sachets 10- 15 ml, corresponding to 1 sachets
Children (1-6 years) 5- 10 ml 5 – 10 ml
infants under 1 year up to 5 ml up to 5 ml

* If the maitenance dose is below 15 ml, Duphalac in bottles should be used

For a precise dosing for infants and children up to 7 years, Duphalac in bottles should be used.

Dosing in HE ( for adults only )

Starting dose: 30 – 45 ml or 2 – 3 sachets, three to four times daily

This dose may be adjusted to maintenance dose to achieve 2 to 3 soft stools per day.

Paediatric population

The safety and efficacy in children (newborn to 18 years of age) with ME have not been established. No data are available.

Elderly patients and patients with renal or hepatic insufficiency

No special dosage recommendations exist, since systemic exposure to lactulose is negligible.

Contraindications

Do not take Duphalac oral solution

– If you are hypersensitive (allergic) to lactose or to any of the ingredients of Duphalac oral solution

– if you suffer from galactosactnia

– Gastrointestinal obstruction, digestive perforation or risk of digestive perforation

Warnings and special precautions for use Consultation of a physician is advised in case of:

–        Painful abdominal symptoms of undetermined cause before the treatment is started

–        Insufficient therapeutic effect after several days.

Patients who arc intolerant to lactose should take Duphalac oral solution with care (because it contains lactose, see section Important information about the ingredients).

The dose normally used in constipation should not pose a problem for diabetics. However, the dose used in the treatment of HE is usually much higher and sugar content of the medicine should be taken into consideration for diabetics.

Chronic use of unadjusted doses and misuse can lead to diarrhea and disturbance of the electrolyte balance.

This product contains lactose, galactose and small amounts of fructose. Therefore, patients with the rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Paediatric population:

Use of laxatives in children should be exceptional and under medical supervision. It should be taken into account that the defaecation reflex could be disturbed during the treatment.

Interactions

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

No interaction studies with other medications have been performed.

Pregnancy, lactation and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

During pregnancy, no effects to the feotus arc anticipated, since systemic exposure of lactulose to the pregnant woman is negligible. Duphalac can be used during pregnancy.

Lactation

No effects on the breastfed newbom/infani are anticipated since the systemic exposure of lactulose to the breast-feeding woman is negligible. Duphalac can be used during breastfeeding.

Fertility

No effects are to be expected, since systemic exposure to lactulose is negligible.

Effects on ability to drive and use machines

Duphalac has no or negligee influence on the ability to drive and use machines.

Important information about the ingredients

Duphalac oral solution contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, especially lactose, contact your doctor before taking this medicinal product,

Undesirable effects

Inform your doctor about undemrable effects when using this medicine.

Like all medicines, Duphalac oral solution may cause side effects, although not everyone experiences them.

If you notice any side effects not mentioned in this leaflet, or if any of the side effects gets serious, please inform your doctor or pharmacist.

Summary of the safety profile

Flatulence may occur during the first few days of treatment. As a rule it disappears after a few days.

When dosages higher than instructed are used, abdominal pain and diarrhea may occur. In such a case the dosage should be decreased (see section Overdose).

If high doses (normally only associated with hepatic encephalopathy, HE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhea.

Tabulated list of adverse reactions

The following undesirable effects have been experienced

with the below indicated frequencies

in lactulose-treated patients in placebo-controlled clinical

trials [very common (>= 1/10); common (>=1/100 to <1/10);

uncommon (>=l/1000 to <1/100); rare (>=l/10000 to

<1/1000); very rare (<1/10000)]

Frequency category
Very common Common Uncommon Rare
Gastro

intestinal

disorders

Diarrhea Flatulence, Abdominal

pain, nausea.

vomiting

Investigations Electrolyte imbalance due to diarrhea

Paediatric population

The safety profile in children is expected to be similar as in adults.

Overdose

If you have taken too high a dose you may experience the following symptoms: diarrhoea and/or abdominal pain. Under these circumstances, the treatment should be stopped or the dosage reduced sufficiently for the symptoms to subside.

Extensive fluid loss by diarrhoea or vomiting may require the intake of extra electrolytes. Please ask your doctor or pharmacist for advice.

Pharmacodynamics

Pharmacotherapeutic group: Osmotically acting laxatives

The following is a detailed description of how Duphalac oral solution works. If you would like an explanation or further information regarding this information, please consult your doctor.

In the colon lactulose is broken down by colonic bacteria into low-molecular organic acids. These acids lower the pH in the colonic lumen and increase the volume of the colonic contents via an osmotic effect. These effects stimulate peristalsis of the colon and return normal consistency to the stool. Constipation is corrected and the physiological rhythm of the colon is reinstated.

In hepatic encephalopathy (HE) the effect has been attributed to suppression of proteolytic bacteria by an increase of acidophilic bacteria (e.g. lactobacillus), trapping of ammonia in the ionic form by acidification of the colonic contents, catharsis due to the low pH in the colon as well as an osmotic effect and alteration of bacterial nitrogen metabolism by stimulating the bacteria to utilize ammonia for bacterial protein synthesis. Within this context, however, it should be realized that hyperammonemia alone cannot

explain the neuropsychiatric manifestations of HE. The ammonia might, however, serve as a model compound for other nitrogenous substances.

Lactulose as a probiotic substance strengthens the growth of health promoting bacteria, like Bifidobacterium and Lactobacillus, whereas potentially pathogenic bacteria, like Clostridium and Escherichia coli may be suppressed. This may lead to a more favorable balance of the intestinal flora.

Pharmacokinetics

The following is a detailed description of how Duphalac oral solution is metabolized in the body. If you would like an explanation or further information regarding this information, please consult your doctor.

Lactulose is poorly absorbed after oral administration and reaches the colon unchanged. There it is metabolised by the colonic bacterial flora. Metabolism is complete at doses up to 25 – 50 g or 40 – 75 ml; at higher dosages, a proportion may be excreted unchanged.

Incompatibilities Not applicable.

Shelf life and storage conditions

3 years from the manufacturing date.

Do not store above 25°C.

Store in the original package.

Do not use this medicine after the expiry date stated on the carton and sachet or bottle.

Keep this medicine out of the reach and sight of children.

Pack sizes

Duphalac oral solution comes in

– Sachets containing 15 ml, are made of a polyester/ aluminium/polyethylene laminate.

– Bottles containing 200, 500 or 1000 ml are made of HDPE with polypropylene closures and come with a polypropylene measuring cup. The graduations on the measuring cup are: 2.5 ml, 5 ml, 10 ml, 15 ml, 20 ml, 25 ml and 30 ml.

Not all pack sizes may be marketed.

Further information No special requirements.

The information in this leaflet is limited. For further information, please contact your doctor or pharmacist.

Date of information July 2013

Read all of this leaflet carefully before you start takin£ this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. Always take this medicine exactly as described in this leafet or as your , doctor or pharmacist has told you. You must talk to a doctor if you do not feel better or if you feel worse after several days.

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Phosphalugel Oral suspension in single dose sachets http://healthca.info/2016/09/30/phosphalugel-oral-suspension-single-dose-sachets/ http://healthca.info/2016/09/30/phosphalugel-oral-suspension-single-dose-sachets/#comments Fri, 30 Sep 2016 14:57:00 +0000 http://healthca.info/?p=1389 Drug Phosphalugel is an antacid. It reduces the acidity of the stomach, It is recommended for the treatment of pain, acidity or burning in the stomach or oesophagus Pepsane indicated for the treatment of stomach ache Air-X indications accumulation of gas in the gastrointestinal tract Maalox treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia Composition […]

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Drug Phosphalugel is an antacid. It reduces the acidity of the stomach, It is recommended for the treatment of pain, acidity or burning in the stomach or oesophagus

Pepsane indicated for the treatment of stomach ache

Air-X indications accumulation of gas in the gastrointestinal tract

Maalox treatment of Gastritis,  Dyspepsia, Peptic ulcer, Hiatal hernia

Composition

Each sachet contains:

Colloidal aluminium phosphate gel 20%: 12.380 g.

Excipients: Calcium sulphate dihydrate, pectin, agar 800, orange flavoring agent, potassium sorbate, liquid sorbitol (non-crystallising), purified water.

Phosphalugel does not contain sucrose (sugar).

Phosphalugel Oral suspension in single dose sachets

Indications

Phosphalugel is an antacid. It reduces the acidity of the stomach.

It is recommended for the treatment of pain, acidity or burning in the stomach or oesophagus.

Dosage

The usual dose is 1-2 sachets 2-3 times a day.

The medicine should be taken when pain occurs or in accordance with your doctor’s instructions.

For oral use

Duration of treatment

Taking more than 6 sachets a day does not usually confer any additional benefit. If a dose of 6 sachets a day does not provide sufficient relief, consult your doctor.

Contraindications

Do not take PHOSPHALUGEL oral suspension if:

– if you are hypersensitive (allergic) to aluminium phosphate or any of the other ingredients of PHOSPHALUGEL

– if you have severe kidney problems.

Warnings

Patients with rare hereditary problems of fructose intolerance are advised not to take this medicine.

Phosphalugel contains sorbitol and may therefore cause mild digestive problems (diarrhoea).

The calorific value of sorbitol is 2.6 kcal/g.

If your symptoms do not disappear within 7 days, consult your doctor.

if pain is accompanied by fever or vomiting, consult your doctor immediately.

Interactions

Antacids can REDUCE the effect of a number of other medicines. Please tell your doctor or pharmacist if you are taking any other medicines.

As a precaution, do not take antacids at the same time as other medicines. Other medicines should be taken separately from the antacid (e.g. 2 hours beforehand)

Effects on ability to drive and use machine NA.

Possible side effects

Like all medicines, PHOSPHALUGEL oral suspension can cause side effects, although not everybody gets them.

Constipation

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Please inform your doctor any side effects occur during treatment.

Pregnancy and lactation

This medicine should be used with caution during pregnancy and while breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Over dosage

Excessive doses may cause constipation or even intestinal obstruction. Overdose is more likely to lead to effects in patients with impaired kidney function.

Storage condition: Below 30°C.

Shelf life: 36 months.

Availability: Oral suspension in single-dose sachets; box of 26 sachets of 20g.

Keep out of the reach of children.

Read carefully enclosed leaflet before use.

Please ask your doctor for further information.

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Emycin 250 DHG ( ERYTHROMYCIN 250 MG ) http://healthca.info/2016/09/29/emycin-250-dhg-erythromycin-250-mg/ http://healthca.info/2016/09/29/emycin-250-dhg-erythromycin-250-mg/#comments Thu, 29 Sep 2016 14:13:46 +0000 http://healthca.info/?p=1384 Drug Emycin 250 have composition Erythromycin 250, treatment of respiratory tract infections, gastrointestinal tract infections, skin and soft tissue  infections, neonatal conjutctivitis and Chlamydial conjunctivitis … ROVAS 1.5M IU Indication treatment of Lower, Upper respiratory tract infections CHLORAMPHENICOL 250mg treatment of severe infections caused by susceptible bacteria COMPOSITION: Erythromycin 250 mg Excipients.q.s  1 sachet (Aspartame, […]

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Drug Emycin 250 have composition Erythromycin 250, treatment of respiratory tract infections, gastrointestinal tract infections, skin and soft tissue  infections, neonatal conjutctivitis and Chlamydial conjunctivitis …

ROVAS 1.5M IU Indication treatment of Lower, Upper respiratory tract infections

CHLORAMPHENICOL 250mg treatment of severe infections caused by susceptible bacteria

COMPOSITION:

Erythromycin 250 mg

Excipients.q.s  1 sachet

(Aspartame, orange-flavored powder, sorbitol (powder))

Emycin 250 DHG - ERYTHROMYCIN 250 MG

DOSAGE FORM:

Powder for oral suspension.

PRESENTATION:

Box of 24 sachets x 1.5 g

PHARMACODYNAMICS:

Emycin 250 DHG contains erythromycin that is a macrolide antibiotic with a wide spectrum of activity. Its action is mainly bacteriostatic. but high concentrations are slowly bactericidal against the more sensitive strains. Erythromycin and other macrolides bind reversibly to the 50S subunit of the ribosome, inhibit the protein synthesis.

The actions of erythromycin are increased at moderately alkaline pH (up to about 8.5). particularly in Gram-negative species. Erythromycin has a broad spectrum of activity, including Gram-positive cocci, Streptococcus pneumoniae, Streptococcus pyogenes. Staphylococcus aureus, Bacillus anthracis, Corynebacterium diphteria, Erysipelothris rhusioparthiae, Listeria monocyogenes, Anaerobic Clostridium spp. and Propionibacterium acnes are also usually susceptible. Gram-negative cocci including Neisseria meningitises and N. gonorrhoeas, and Moraxella (Branhametia) catarrhaiis, Bordetella spp., some of Brucella, Flavobacterium, Legionella spp. and Pasteurella, Haemophilus ducreyi, Helicobacter pyforidis, Campylobacter jejuni. Other organisms usually sensitive to erythromycin include Actinomyces, Chlamydiaceae, Rickettsias. Spirochaetes such as Treponema patidum and Borreiia burgdorferi, some Mycoplasmas (notably Mycopiasma pneumoniae), and some of the opportunistic Mycobacteria: Mycobacterium scrofuiaceum and M. kansasii;

PHARMACOKINETICS:

Erythromycin is readily diffused throughout body fluids and tissues e.g. salivary glands, prostate gland, serminal fluid, Relatively high concentrations are found in the liver and spleen.

The concentrations of erythromycin in cerebrospinal fluid are low: however, when meninges are inflamed, the concentration of erythromycin in CSF may be increased. Around 70 to 90% of erythromycin is protein bound.

Over 90% of erythromycin is metabolized in the liver, partly under inactive metabolites; it may be agglomerated in patients with severe hepatic impairment Erythromycin is excreted in high concentrations in the bile. About 2 to 5% of an oral dose is excreted unchanged in the urine.

INDICATIONS:

For treatment of respiratory tract infections, gastrointestinal tract infections, skin and soft tissue infections, neonatal conjutctivitis and Chlamydial conjunctivitis. Prophylaxis of recurrent courses of acute rheumatism.

CONTRAINDICATIONS:

Patients who are hypersensitive to erythromycin, patients with a history of taking erythromydn while suffering from hepatic disorder, and deaf. The use of erythromycin is considered not to be safe in patients with disorders of porphyrin metabolism because it causes acute courses. Do not combine with terfenadine, particularly in patients with cardiac disease, arrhythmia, bradycardia, prolonged Q-T interval, ischemia, electrolyte disorders

PRECAUTIONS:

Caution should be taken in case of hepatic and renal impairment Patients suffered from arrhythmia and other kind of cardiac diseases.

PREGNANCY AND LACTATION:

Emycin 250 ( Erythromycin ) has been reported to cross the placental barrier in humans; therefore, do not indicate erythromycin estotete to pregnant women because it increases the risk of hepatotoxicity. No reports about adverse events to pregnant women on other type of erythromycin Erythromycin is excreted in breast milk, but there are no published reports of adverse effects in breast- feeding infants.

VEHICLE DRIVERS AND MACHINERY OPERATORS:

Emycin 250 does not affect the ability to drive vehicles and operate machinery.

INTERACTIONS:

Concomitant administration of erythromycin and asternizoie, terfenadine causes a risk of points torsion, ventricular tachycardia and death. Erythromycin may inhibit the metabolism of carbamazepine and valproic acid, enhances the serum concentration of these drugs, and consequently an increased risk of toxicity.

Erythromycin may be antagonistic with cloramphenicof or lincomycin. Erythromycin decreases the clearance of xanthine e.g  theophylline, caffeine, alfentanil, midazolam or triazolam; therefore, it increases the concentration and action of these drugs.

Erythromycin extend prothrombin time; the combination of erythromycin and warfarin may result in bleeding due to warfarin catabolism reduction in the Erythromycin elevates cyclosporin rotation and creatininaemia. Erythromycin inhibits the metabolism of ergotamine and increased risk of vasospasm from ergotamine Caution should be taken when combining erythromycin and lovastatin because it can cause the risk of rhabdomyolysis.

ADVERSE EFFECTS:

Common: colic, vomiting, diarrhea, skin rash.

Unfrepuent: urticaria.

Rare: anaphylactic reaction, arrhythmia, elevated transaminases, increased serum bilirubin, cholestatic hepatitis, restorable deaf.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

Administration of epinephrine, corticosteroids and antihistamines to treat allergic reactions; gastric lavage to eliminate the part of drug unabsorbed. Supportive treatment should be applied if required.

DOSAGE & ADMINISTRATION:

Emycin 250 should be taken immediately before meals, and the therapy course must be pursued (5-10 days)

Children: Usual dose: 30 – 50 mg/kg body-weight/day, in 2 – 4 divided doses.

Children under 2 years of age: % sachet x 4 times daily (total dose: 500 mg/ day).

Children from 2 to 8 years of age: 1 sachet x 4 times daily (total dose: 1 g/ day).

The dose may be doubled in severe infections.

Of as directed by the physician

Read the directions carefully before use.

Shelf-life: 36 months from the manufacturing date.

Consult the physician tor more information.

Storage conditions: Store in dry places, not exceeding 300 C. protect from light

Emycin 250 is for prescriptions only.

Specifications: Manufacturers

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ROVAS 1.5M IU ( Spiramycin 1.500.000 IU ) http://healthca.info/2016/09/28/rovas-1-5m-iu-spiramycin-1-500-000-iu/ http://healthca.info/2016/09/28/rovas-1-5m-iu-spiramycin-1-500-000-iu/#comments Wed, 28 Sep 2016 16:11:27 +0000 http://healthca.info/?p=1381 Drug Rovas 1.5M have composition Spiramycin 1.5M, Indication treatment of Lower, Upper respiratory tract infections : otitis, sore throat, acute bronchitis, non-malignant skin infections such as impetigo skin ulcer CHLORAMPHENICOL 250mg treatment of severe infections caused by susceptible bacteria Zidocin DHG Treatment of acute, chronic or recurrent stomatological infections COMPOSITION: Spiramycin 1.500.000 IU Excipients.q.s  1 […]

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Drug Rovas 1.5M have composition Spiramycin 1.5M, Indication treatment of Lower, Upper respiratory tract infections : otitis, sore throat, acute bronchitis, non-malignant skin infections such as impetigo skin ulcer

CHLORAMPHENICOL 250mg treatment of severe infections caused by susceptible bacteria

Zidocin DHG Treatment of acute, chronic or recurrent stomatological infections

COMPOSITION:

Spiramycin 1.500.000 IU

Excipients.q.s  1 tablet

(Tapioca starch, sodium starch glycolate. talc, magnesium stearate, aerosil, PVP. HPMC, PEG 6000, titanium dioxide)

ROVAS 1.5M IU - Spiramycin 1.500.000 IU

DOSAGE FORM:

Film coated tablets.

PRESENTATION:

Box of 2 blisters x 8 tablets.

PHARMACODYNAMICS:

Rovas 1.5M contains Spiramycin – a macrolide antibiotic. At serum concentrations Rovas is bacteriostatic but at tissue concentrations the drug is bactericidal.

Action mechanism: Rovas acts on 50S subunit of the bacterial ribosome, prevents protein synthesis by bacteria.

Organisms being sensitive to Rovas: Streptococcus, meticillin-sensitive Staphylococcus. Pneumococcus. Meningococcus. Gonococcus. Rhodococcus equi, Corynebacterium diphteriae. Bordetella pertussis. Leptospira. Moraxella. Branhamella catarrhalis. Helicobacter pylon. Campylobacter jejuni. Borrelia burgdorferi, Coxielia. Mycoplasma pneumoniae. Chlamydia trachomatis. Treponema pallidum. Acbnomyces. Propionibacterium acnes. Mycoplasma hominis, Mobiluncus. Eubacterium, Porphyromonas. Toxoplasma gondii. Some organisms being medium-sensitive: Neisseria gonorrhoeae, Vibrio, Ureaplasma, Legionella pneumophila. Some bacteria that have to be made a bacterial-graph to determine the sensitivity: Campylobacter coli, Streptococcus pneumoniae. Peptostreptococcus, Enterococcus. Clostridium pertringens.

PHARMACOKINETICS:

Rovas 1.5M is well dispersed into the body. The drug’s concentration is highly obtained in lung, tonsil, bronchi and sinuses. The elimination half-life of Spiramycin is between 5 and 8 hrs. The drug is not excreted in active form through kidney: thus, it is not necessary to adjust the dose in case of renal impairment.

INDICATIONS: For treatment of Rovas 1.5M :

– Upper respiratory tract infections: otitis, sore throat, tonsillitis, acute sinusitis; stomatological infections.

– Lower respiratory tract infections: acute bronchitis, acute course of chronic bronchitis, public pneumonia (in patients without risky elements, without clinical symptoms). In case of doubting about an atypical pneumonia. Rovas is indicated in any cases of serious or non-serious diseases.

– Treatment of non-malignant skin infections such as impetigo, skin ulcer, erysipela.

– Treatment of genital infections not caused by gonococcus.

– Prophylaxis of meningitis caused by meningococcus when patients contra-indicated in the prescription of rifamptcin.

– Prophylaxis of innate toxoplasmosis in pregnancy.

– Replacement therapy in case of patients allergic to penicillin.

– Prophylaxis of recurrences of acute rheumatism in patients allergic to penicillin.

CONTRAINDICATIONS:

Hypersensitivity to macrolide antibiotics.

PRECAUTIONS:

Patients with hepatic disorders. Breast-feeding should be discontinued when taking the drug.

INTERACTIONS:

Spiramycin inactivates contraceptives.

ADVERSE EFFECTS:

Frequently: Nausea, vomiting, diarrhoea, Rarely: fatigue, sweating, allergic skin reactions.

Inform your physician about any adverse effects occur during the treatment.

OVER DOSAGE:

No documents have been reported.

DOSAGE 4 ADMINISTRATION:

Rovas 1.5M should be taken at least 2 hrs prior or 3 hrs after meals.

The therapy process must be completely pursued.

Oral doses

Adults: 1 – 2 tablets x 3 times /day.

Prophylaxis of meningitis caused by meningococcus

Adults: 2 tablets/time, each 12 hours for one time.

– Prophylaxis ot innate toxoplasmosis in pregnancy: 6 tablets/day. in many divided doses, within 3 weeks, repeat the dose every 2 weeks.

Or as directed by the physician

Read the directions carefully before use Consult the physician for more information This drug is for prescriptions only

Shelf-life: 36 months from the manufacturing date.

Storage conditions: store in dry places, not exceeding 30°C.

Specifications: Manufacturer’s

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Tips treat of Acne simple with egg whites and lemon http://healthca.info/2016/09/26/tips-treat-acne-simple-egg-whites-lemon/ http://healthca.info/2016/09/26/tips-treat-acne-simple-egg-whites-lemon/#respond Mon, 26 Sep 2016 16:38:07 +0000 http://healthca.info/?p=1374 Egg whites and lemon mixed together treat of acne are very cheap and efficient. This mixture not only reduce acne but also makes the skin becomes cleaner and smoother. Whitening skin ultrafast from tamarind Treat melasma by Bananas super effective while skin with mask homemade In egg have a lot of  protein good for skin. […]

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Egg whites and lemon mixed together treat of acne are very cheap and efficient. This mixture not only reduce acne but also makes the skin becomes cleaner and smoother.

Whitening skin ultrafast from tamarind

Treat melasma by Bananas super effective

while skin with mask homemade

In egg have a lot of  protein good for skin. Egg whites are rich in vitamin B, this ingredient has anti-oxidant, anti-aging, moisture balance, removes dead cells … Especially eggs brought in preventing and treating acne extremely effective.

Treat of Acne simple with egg whites and lemon

Lemon juice works to tighten pores, repelling bacteria, lighten the skin and reduce the discoloration.

Treat of Acne simple with egg whites and lemon

Egg whites and lemon are considered interesting combination helps you quickly head acne astringent, anti-inflammatory, reduce acne effectively.

Prepare:

– A lemon

– An egg whites

Treat of Acne simple with egg whites and lemon

Making :

Step 1: Wash the face and then wipe dry with a soft towel.

Step 2: Squeeze extract half a lemon  and egg whites together mixed

Step 3: Use absorbent cotton mixture then rub all over the facial area.

Step 4: To mix up on the skin about 30 minutes and then rinse your face with warm water and to dry with soft towel and feel the changes to your face skin

Perform the above formula 2 times / week regularly to get the best results for treat of Acne.

Treat of Acne simple with egg whites and lemon

Note:

Avoid applying to the sensitive area near the mouth and eyes. You should not mix egg whites with too lemon, your skin is dry

During the application  treat of Acne, you should protect your skin and avoid the sun when outdoors by lemon and egg whites can cause thinning of the skin.

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