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Drugs Doxycyclin STADA have composition Doxycycline 100mg. Doxycycline is administered treatment for infections: respiratory tract infections, urinary tract Infections, sexually transmitted diseases, skin infections, ophthalmic infections

CotrimStada forte indications: Urinary tract infections, Respiratory tract infections

Aticef 500mg indications : Respiratory tract infections, skin and soft tissue infections

Clindastad 150 indications is a primarily bacteriostatic antibacterial used chiefly in the treatment of infections

COMPOSITION

Each film-coated tablet contains:

Doxycycline 100mg

(as doxycycline hyclate  115.40 mg)

Excipientsq.s   1 tablet : (Maize starch, lactose monohydrate, gelatin, talc, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, hypromellose, PEG 6000, titanium dioxidei yellow quinoline)

Doxycyclin STADA - Doxycycline 100mg

DESCRIPTION

Yellow round-shaped film-coated tablet, biconvex, plain on both sides.

PHARMACODYNAMICS

Doxycycline 100mg is primarily bacteriostatic and is believed to exert its antimicrobial effect by the inhibition of protein synthesis. Doxycycline 100mg is active against a wide range of Gram-positive and Gram- negative bacteria and certain other micro-organisms.

PHARMACOKINETICS

Doxycycline 100mg is readily and almost completely absorbed from the gastrointestinal tract and absorption is not significantly affected by the presence of food in the stomach or duodenum.

About 80 to 95% of doxycycline in the circulation is reported to be bound to plasma proteins. Mean peak plasma concentrations of 2.6 mcglml have been reported 2 hours after a 200 mg dose by mouth, falling to 1.45 mcg/ml at 24 hours. Its biological half-life varies from about 12 to 24 hours. It is widely distributed in body tissues and fluids.

In patients with normal renal function about 40% of a dose is slowly excreted in the urine, although more is excreted by this route if the urine Is made alkaline. However, the majority of a dose of doxycycline is excreted in the faeces after chelation in the intestines.

INDICATIONS

Doxycycline 100mg has been found clinically effective in the treatment of a variety of infections caused by susceptible strains of Gram-positive and Gram-negative bacteria and certain other microorganisms. Doxycycline is administered treatment for infections: respiratory tract infections, urinary tract Infections, sexually transmitted diseases, skin infections, ophthalmic infections, infections Rickettsial and other infections

DOSAGE AND ADMINISTRATION

Doxycyclin STADA 100mg Tabs is given orally. It should be given with plenty of fluid, with the patient in an upright position and may be given with food if gastric irritation occurs.

The usual ore/ dosage of doxycycline for adults: 100 mg every 12 hours on the first day of treatment, followed by 100 mg daily given in 1 or 2 divided doses. For severe infections, adults should receive 100 mg every 12 hours

The usual oral dosage of doxycycline for children older than 8 years of ago weighing more than 45 kg. 100 mg every 12 hours on the first day of treatment, followed by 100 mg daily given in 1 or 2 divided doses For severe infections, use 100 mg every 12 hours.

Children older than 8 yeans of age weighing 45 kg or less: Should receive 4.4 mglkg given in 2 divided doses on the first day of treatment, followed by 2.2 mg/kg daily given in 1 or 2 divided doses. For severe infections, use 4 A mg/kg daily.

CONTRAINDICATIONS

Known hypersensitivity to doxycycline or other tetracyclines.

Children younger than 8 years of age.

Pregnancy and lactation Severe hepatic dysfunction.

WARNINGS AND PRECAUTIONS

Dental and bone effects’ Use dunng tooth development (eg., pregnancy, infancy, childhood up to 8 years of age) may cause permanent yellow-gray to brown discoloration of teeth and enamel hypoplasia Effects are most common following long-term use, but may occur following repeated short-term use. Tetracyclines form a stable calcium complex in any bone-forming tissue. Reversible decrease in fibula growth rate has occurred in premature infants receiving oral tetracyclines. Photosensitivity reactions: Photosensivity. manifested as an exaggerated sunburn reaction on areas of the body exposed to direct sunlight or ultraviolet light, has occurred with tetracyclines. Oral doxycycline hyclate should be discontinued at the first sign of skin erythema.

Oral doxycycline may result in overgrowth of non susceptible organisms including fungi.

To reduce the nsk of esophageal irritation and ulceration, the tablets should be administered with adequate amounts of fluid

DRUG INTERACTIONS

Antacids:Antacids containing aluminum, calcium, or magnesium decreased absorption of doxycycline. Anticoagulants: Oral anticoagulants decreased plasma prothrombin activity; anticoagulant dosage may need to be adjusted in patients receiving doxycycline.

Anticonvulsants: Barbiturates, carbamazepine. or phenytoin decreased doxycycline half-life. Bismuth subsalicylate: Decreased absorption of doxycycline.

Hormonal contraceptives: Decreased effectiveness of oral contraceptive.

Iron: Iron-containing preparations decreased absorption of doxycycline.

Methoxyflurane: Concomitant use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Penicillins: Potential pharmacologic interaction (antagonism); avoid concomitant use.

PREGNANCYAND LACTATION

Pregnancy

In humans, the use of tetracyclines during a limited number of pregnancies has not revealed any specific malformation to date. The administration of tetracyclines during the second and the third trimesters results in permanent discolouration of teeth in the offspring. As a consequence, doxycycline is contraindicated during pregnancy.

Lactation

Doxycycline and other tetracyclines are distributed into milk. Doxycycline 100mg is contraindicated in nursing women. Because of the potential for serious adverse reactions in nursing infants, discontinue nursing or doxycycline, taking into account the importance of the drug to the woman.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

The effect of doxycycline on the ability to drive or operate heavy machinery has not been studied. There is no evidence to suggest that doxycycline may affect these abilities.

ADVERSE REACTIONS

Adverse effects reported in patients receiving doxycycline include headache, common cold, flu symptoms, toothache or tooth disorder, Gl symptoms (diarrhea, nausea, dyspepsia) and joint pain, hepatotoxicity.

OVERDOSAGE

Acute overdosage with antibiotics is rare, In the event of overdosage discontinue medication Gastric lavage plus appropriate supportive treatment is indicated

Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30°C

SHELF-LIFE

36 months from the date of manufacturing.

PACKAGING

Blister of 10 tablets. Box of 1 blister Blister of 10 tablets. Box of 2 blisters.

Blister of 10 tablets. Box of 10 blisters.

Bottle of 100 tablets. Box of 1 bottle.

SPECIFICATION: Manufacturer’s specification.

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