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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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