ERYTHROMYCIN STEARATE TABLETS BP 500MG
Film coated tablets
Each film coated tablet contains:
Erythromycin stearate BP
Eq. to Erythromycin 500 mg
Alternative to penicillin in hypersensitive patients, oral infections, campylobacter enteritis, syphilis non-gonococcal urethretis, respiratory tract infections (including legionnaires disease), skin infections; chronic prostatis, diphtheria and whooping cough prophylaxis; Acne vulgaris and rosacea.
Hepatic impairment, renal impairment; predisposition to QT interval prolongation (including electrolyte disturbances, concomitant use of drugs that prolong QT interval); avoid in poryphyria; pregnancy (not known to be harmful) and breast feeding (only small amounts in milk).
Paediatrics: Reduced dose necessary.
Elderly: No special problem.
May potentiate action of carbamazepine, cyclosporine, theophylline warfarin. Increases serum digoxin levels, reduces therapeutic effect of penicillins, terfenadine and astemizole increases the risk of the adverse effect on the heart.
Side effects and adverse reactions
Nausea, vomiting, abdominal discomfort, diarhhoea, (antibiotic – associated colitis reported); less frequently urticaria, rashes-and other allergic reactions; reversible hearing loss reported after large doses; cholestatic jaundice, infantile hypertrophic pyloric stenosis, cardiac effects (including chest pain and arrhythmias), myasthenia-like syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis also reported.
It is unwise to give erythromycin with a history of previous hypersensitivity reactions to the drug. It should also be avoided in patients with existing liver dysfunction or who are currently receiving potentially hepatotoxic drugs.
By mouth, ADULT and CHILD over 8 years, 250 – 500 mg every 6 hours or 0.5 – 1 g every 12 hours; up to 4 g daily in severe infections; CHILD up to 2 years 125 mg every 6 hours, 2 – 8 years 250 mg every 6 hours, doses doubled for severe infections.
Early syphilis, 500 mg 4 times daily for 14 days.
Uncomplicated genital Chlamydia, non-gonococcal urethritis, 500 mg twice daily for 14 days.
By intravenous infusion, ADULT and CHILD severe infections, 50 mg/kg daily by continuous infusion or in dividend doses every 6 hours; mild infections (oral treatment not possible), 25mg/kg daily; NEONATE 30 – 45 mg/kg daily in 3 divided doses.
10 tablets packed in a Alu/Alu pack. Such 10 Alu/Alu packed in unit printed duplex board carton along with its package insert. Such cartons packed in export worthy corrugated box.
Store in a cool and dry place. Protect from light.
36 months from the date of manufacture.
Mfg. Lic. No: G/28/1231
Nafdac Reg. No: B4-2465
Manufactured in India by
Globela Pharma Pvt. Ltd.
Surat – 394 230, Gujarat.
Manufactured in India for
EVERDESTINY PHARMACEUTICALS LTD
20 OSHUNFOLARIN STREET,