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Romycin
Azithromycin Dihydrate USP
NAME | STRENGTH | PACK SIZE | DOSAGE FORM |
---|---|---|---|
Romycin 500 | 500 mg | 2X10 | Tablet |
Romycin 250 | 250 mg | 2X4 | Capsule |
Romycin 15 | 200 mg / 5 ml | 15 ml | Powder for suspension |
Romycin 20 | 200 mg / 5 ml | 20 ml | Powder for suspension |
Romycin 35 | 200 mg / 5 ml | 35 ml | Powder for suspension |
Romycin 50 | 200 mg / 5 ml | 50 ml | Powder for suspension |
Description
Azithromycin is a macrolide antibiotic. It acts by binding to the 50 S ribosomal subunit of susceptible bacteria.
Composition
Romycin 250 Capsule: Each capsule contains Azithromycin 250 mg as Azithromycin Dihydrate USP. Romycin 500 Tablet: Each Tablet contains Azithromycin 500 mg as Azithromycin Dihydrate USP. Romycin 15 ml Suspension: After reconstitution, each 5 ml suspension contains Azithromycin 200 mg as Azithromycin Dihydrate USP. Romycin 20 ml Suspension: After reconstitution, each 5 ml suspension contains Azithromycin 200 mg as Azithromycin Dihydrate USP. Romycin 35 ml Suspension: After reconstitution, each 5 ml suspension contains Azithromycin 200 mg as Azithromycin Dihydrate USP. Romycin 50 ml Suspension: After reconstitution, each 5 ml suspension contains Azithromycin 200 mg as Azithromycin Dihydrate USP.
Indications And Uses
Romycin is indicated for the treatment of mild to moderate infections; Lower respiratory tract infection: Acute bacterial exacerbation of chronic obstructive pulmo nary disease (COPD), Community acquired pneumonia of mild severity patients appropriate for outpatient oral therapy. Upper Respiratory tract Infection: Acute pharyngitis, tonsillitis. Gastrointestinal tract infection: Enteric fever or typhoid fever, infectious diarrhoea etc. Skin and skin structure Infections: Uncomplicated skin and skin structure infections. Sexually transmitted diseases: Non- gonococcal urethritis and cervicitis. Mycobacterial infections: For prophylaxis, disseminated Mycobacteruim avium complex (MAC) disease.
Dosage And Administration
Romycin Capsule should be given at least 1 hour before or 2 hours after a meal and tablets can be taken with or without food. Adults- The recommended dose of Romycin for the treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD), pneumonia of mild severity, pharyngitis , tonsillitis and uncomplicated skin and skin structure infections is 500 mg as a single dose on the fir st day followed by 250 mg once daily on days 2 through 5. For the treatment of Enteric fever or typhoid fever the recommended dose is 1g once daily for 5 days or 1g on day first and 500 mg for the following 6 days and for infectious diarrhoea the recommended dose is 1g once daily. The recommended dose of Azithromycin for the treatment of genital ulcer disease is 1000 mg as single dose. The recommended dose of Azithromycin for the treatment urethritis and cervicitis is a single dose of 2000 mg Azithromycin . Children - Use of Azithromycin over 6 months of age is recommended. In acute otitis media and community-acquired pneumonia the recommended dose of Romycin oral suspension is 10 mg/kg as a single dose on the first day followed by 5 mg kg/Ð1 day Ð1 on day 2-5 (not exceeding 500 mg/day). The recommended dose of Romycin for oral suspension for the treatment of children with pharyngitis/tonsillitis is 12 mg/kg once a day for 5 days (not exceeding 500 mg/day)
Side Effect
Most reported side effects were mild to moderate se verity and reversible upon discontinuation. Transient elevations of liver enzyme values and rarely cholestatic jaundice have been reported. Rash, headache, dizziness may occur, Gastrointestinal side effects are; nausea, vomiting, diarrhea or abdominal pain.
Precaution
Because Azithromycin is principally eliminated via the liver, thus caution should be exercised when Azithromycin is administered to patients with impaired hepatic functions. Pregnancy: Azithromycin should be used during pregnancy only if clearly needed. Nursing mother: Caution should be exercised when Azithromycin is administered to a nursing mother. Pediatrics' use: Safety and effectiveness of children under 6 months of age have not been established for Azithromycin.
Use In Pregnancy Lactation
Pregnancy: Pregnancy Category B. In the animal studies, no evidence of harm to the fetus due to Azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if clearly needed. Lactation: It is not known whether Azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azithromycin is administered to a nursing woman.
Drug Interactions
Azithromycin should be taken at least 1 hour before or 2 hours after taking antacids. Concomitant administration of ergot derivatives and Azithromycin should be avoided. Caution should be exercised while co-administration of Digoxin and Cyclosporin is necessary.
Storage
Store in cool & dry place, below 25°C and protect from light. Keep it out of children's reach.
Contraindications
Azithromycin is contra-indicated in patients with known hypersensitivity to Azithromycin, erythromycin or any macrolide antibiotic
How Supplied
Romycin 250 Capsule: Box contains 08 (2×4) capsules alu-alu bl ister pack. Romycin 500 Tablet : Box contains 20 (2×10) tablets in alu-alu blister pack. Romycin Suspension 15 ml: Bottle contains dry powder for 15 ml oral suspension with a measuring cup & dropper. Romycin Suspension 20 ml: Bottle contains dry powder for 20 ml oral suspension with a measuring cup & dropper . Romycin Suspension 35 ml: Bottle contains dry powder for 35 ml oral suspension with a measuring cup & dropper. Romycin Suspension 50 ml: Bottle contains dry powder for 50 ml suspension with a measuring cup & dropper.