Erocin 250 mg Tablet

Erocin 250 mg Tablet

DESCRIPTION

Erocin (Erythromycin) is a macrolide antibiotic. The antibacterial action of Erythromycin may be inhibitory or bactericidal, depending on high concentration and the type of organisms.

The serum half-life is approximately 1.5 hr normally. Large amounts of an administered dose are excreted in the bile and lost in feces, and only 5% excreted in the urine. Absorbed drug is distributed widely except to the brain and cerebrospinal fluid. Erythromycin is taken up by polymorphonuclear leukocytes and macrophages. It persists in the tissues for longer periods than in the serum.

Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit of 70S ribosome occurs in these organisms, but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Gram positive bacteria, some Gram negative bacteria and against mycoplasma and chlamydia.

COMPOSITION

Erocin 250 : Each film-coated tablet contains Erythromycin Stearate USP equivalent to 250 mg Erythromycin.

Erocin 500 : Each film-coated tablet contains Erythromycin Stearate USP equivalent to 500 mg Erythromycin.

Powder for Suspension : After reconstitution each 5 ml suspension contains Erythromycin Ethylsuccinate USP equivalent to 125 mg

Erythromycin.

INDICATIONS

Upper respiratory tract infections: Tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary infections in colds and influenza.

Lower respiratory tract infections: Tracheitis, bronchitis, pneumonia, bronchiectasis.

Ear infections: Otitis media and otitis externa, mastoiditis. Eye infections: Blepharitis.

Skin and soft tissue infections: Boils, curbuncles, paronychia, abscesses, acne, impetigo, cellulitis, erysipelas.

Genitourinary tract infections: Urethritis, gonorrhea, prostatitis, chlamydial infections, chancroid.

Bone infections: Osteomyelitis. Prophylaxis: Pre and post operative, trauma, burns, rheumatic fever. Other infections: Diphtheria, whooping cough, Legionnaire's disease, intestinal amebiasis, syphilis, lymphogranuloma venerum.

DOSAGE AND ADMINISTRATION

Age, weight and severity of the infection are important factors in determining the proper dosage.

Adults and children over 8 years : 250-500 mg every 6 hours or 500 mg-1 g every 12 hours; upto 4 g daily in severe infections.

Children 2-8 years : 250 mg every 6 hours, doses doubled for severe infections.

Children up to 2 years : 125 mg every 6 hours.

Early Syphilis : 500 mg 4 times daily for 14 days.

Urethritis due to C. trachomatis or U. urealyticum : 800 mg 3 times a day day for 7 days.

Intestinal amebiasis :

Adults: 250 mg 4 times daily for 10 to 14 days

Children: 30 to 50 mg/kg/day in divided doses for 10 to 14 days.

Acne : Initially, 250 mg twice daily, which may be reduced to a maintenance dose of 250 mg once daily after one month according to response.

Gonorrhea : For disseminated infection, 500 mg 4 times daily for 7 days.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

Side effects are rare. The most frequent of them are gastrointestinal and are dose related. They are nausea, vomiting, abdominal pain, diarrhea and anorexia etc. Mild allergic reaction such as urticaria and skin rashes may also occur.

CONTRAINDICATIONS

Erythromycin is contraindicated to patients who are hypersensitive to it. It should also be avoided in patients with existing liver dysfunction or who are currently receiving potentially hepatotoxic drug.

PRECAUTIONS

Caution should be exercised in administering Erythromycin to patients with impaired hepatic function, since the antibiotic is excreted principally by the liver. The use of Erythromycin in patients who are receiving concomitant high doses of Theophylline may be associated with an increase in serum Theophylline and potential Theophylline toxicity. If symptoms of toxicity develop, the dose of Theophylline should be reduced.

Use in pregnancy

There is no evidence that the use of Erythromycin is hazardous in pregnancy though it does cross the placental barrier. However, like all drugs, Erythromycin should be used in pregnancy only when clearly indicated.

Use in lactation

Erythromycin is excreted in human milk. Caution should be exercised when Erythromycin is administered to a nursing mother.

DRUG INTERACTIONS

Concomitant use of Erythromycin and Theophylline or Digoxin may result in elevated Theophylline or Digoxin levels. There have been reports of increased anticoagulant effects when Erythromycin and oral anticoagulants are used concomitantly.

SUPPLY

Erocin 250 : Each box contains 5 x 10 tablets in blister strips.

Erocin 500 : Each box contains 3 x 10 tablets in blister strips.

Powder for Suspension : Each bottle contains powder to prepare 100 ml suspension