Before reconstitution: White colored powder with characteristic flavor of banana.
After reconstitution: Off-white colored suspension with characteristic flavor of banana.
Each 5 ml suspension contains: Azithromycin Dihydrate USP 200 mg.
Azithromycin (Romycin) is an azalide antibiotic, a subclass of macrolide antibiotics. It acts by binding with the 50's ribosomal subunit of susceptible microorganisms and thus interfering with microbial protein synthesis. Azithromycin has been shown to be active against most strains of the Gram-positive and Gram-negative microorganisms and in clinical infections of Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia trachomatis, etc. About 40% Azithromycin of an oral dose is absorbed. After oral administration, Azithromycin is rapidly absorbed and widely distributed throughout the body.
Pharmacology: Pharmacodynamics: Azithromycin is an azalide, a sub-class of macrolide antibiotics. By binding to the 50S-ribosomal subunit, azithromycin avoids the translocation of peptide chains from one side of the ribosome to the other. As a consequence of this, RNA-dependent protein synthesis in sensitive organisms is prevented.
PK/PD relationship: For azithromycin, the AUC/MIC is the major PK/PD parameter correlating best with the efficacy of azithromycin. Following the assessment of studies conducted in children, the use of azithromycin is not recommended for the treatment of malaria, neither as monotherapy nor combined with chloroquine or artemisinin-based drugs, as non-inferiority to anti-malarial drugs recommended in the treatment of uncomplicated malaria was not established.
Mechanism of resistance: Resistance to azithromycin may be inherent or acquired. There are three main mechanisms of resistance in bacteria: target site alteration, alteration in antibiotic transport and modification of the antibiotic. Complete cross-resistance exists among Streptococcus pneumoniae, beta hemolytic streptococcus of group A, Enterococcus faecalis and Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA) to erythromycin, azithromycin, other macrolides and lincosamides.
Pharmacokinetics: Absorption: The biological availability of azithromycin after oral administration is approximately 37%. Peak plasma levels are achieved 2-3 hours after taking the medicinal product.
Distribution: After oral administration, azithromycin is distributed throughout the entire body. Pharmacokinetic studies have shown clearly higher azithromycin levels in the tissues than in the plasma (up to 50 times the maximum observed concentration in plasma). This indicates that the substance is bound in the tissues in considerable quantities. Concentrations in the infected tissues, such as lungs, tonsil and prostate are higher than the MRC90 of the most frequently occurring pathogens after a single dose of 500 mg. The protein binding of azithromycin in serum is variable and varies, depending on the serum concentration, from 52% at 0.05 mg/l to 12% at 0.5 mg/l. The steady state distribution volume is 31.1 l/kg.
Elimination: The terminal plasma-elimination half-life closely follows the tissue depletion half-life from 2 to 4 days. Approximately 12% of an intravenously administered dose of azithromycin is, over a period of 3 days, excreted unchanged in the urine. High concentrations of unchanged azithromycin were found in human bile. In this, ten metabolites were also detected (formed by N- and O- desmethylation, by hydroxylation of the desosamin and aglycon rings and by splitting the cladinose conjugate). A comparison of fluid chromatography and microbiological assessment methods shows that the metabolites are microbiologically inactive. In animal models, high concentrations of azithromycin were found in phagocytes. Also, it has been shown that during active phagocytosis higher concentrations of azithromycin are released than during inactive phagocytosis. In animal models, this process was shown to contribute to the accumulation of azithromycin in infectious tissue.
Romycin is indicated for the treatment of patients with infections caused by susceptible organisms: Lower respiratory tract infection: Acute bacterial exacerbation of chronic obstructive pulmonary disease (COPD), Community acquired pneumonia and Otitis media.
Upper respiratory tract infection: Acute pharyngitis, tonsillitis.
Gastrointestinal infection: Cholera, diarrhea, Typhoid/Enteric fever 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 Mycobacterium avium complex disease.
Adults: The recommended dose of Romycin for the treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD), pneumonia, pharyngitis, tonsillitis and uncomplicated skin and skin structure infections is 500 mg on the first day followed by 250 mg once daily on day 2 to 5. In typhoid fever recommended dose is 1g on day first and 500 mg for the next 6 days or 1g once daily for 5 days. For the treatment of genital ulcer disease, 1000 mg single dose & in urethritis and cervicitis is a single dose 2000 mg Azithromycin.
Children dosage: In acute otitis media and community-acquired pneumonia of children above 6 months of age the recommended dose of Azithromycin is 10 mg/kg as s single dose on the first day followed by 5 mg/kg on days 2-5 (not exceeding 500 mg/day).
The recommended dose of Azithromycin for the treatment of children with pharyngitis/tonsillitis is 12 mg/kg once a day for 5 days (not exceeding 500 mg/day). In typhoid/enteric fever dose is 20 mg/kg once daily for 5 days.
Overdose: Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. In the event of overdosage, general symptomatic and supportive measures are indicated as required.
Treatment: In the event of overdose the administration of medicinal charcoal and general symptomatic treatment and supportive measures are indicated as required.
Azithromycin is contraindicated in patients with known hypersensitivity to Azithromycin, Erythromycin, or any macrolide antibiotic.
Because Azithromycin is principally eliminated via the liver, thus caution should be exercised when azithromycin is administered to patients with impaired hepatic functions.
Azithromycin should be used during pregnancy only if needed. And it is not known whether azithromycin is excreted in breast milk, so caution should be exercised when it is administered to a nursing mother.
Most reported side effects were mild to moderate severity and reversible upon discontinuation. Transient elevation 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.
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 with co-administration of Digoxin and Cyclosporin.
Special Precautions for Handling and Disposal: Any unused medicine should be disposed properly.
Consult a pharmacist or local waste management center for more details about how to safely discard expired or unused medicines.
Store in a cool dry place, below 30°C. Protect from light.
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Romycin powd for oral susp 200 mg/5 mL
15 mL x 1's
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