Odazyth 250 mg capsule: Each capsule contains Azithromycin 250 mg as Dihydrate USP.
Odazyth 500 mg tablet: Each tablet contains Azithromycin 500 mg as Dihydrate USP.
Odazyth powder for suspension: After reconstitution each 5 ml suspension contains Azithromycin 200 mg as Dihydrate USP.
Odazyth® is a preparation of Azithromycin, which is an azalide antibiotic, a subclass of macrolide antibiotic. Azithromycin is active against wide range of Gram-positive and Gram-negative organisms. It acts by binding to the 50s ribosomal subunit of susceptible microorganisms and thus interfering with microbial protein synthesis.
Odazyth® tablet and capsule for adult:
Community-acquired pneumonia (mild severity) / Pharyngitis/Tonsillitis (second line) / Skin/skin structure (uncomplicated): 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease: 500 mg once daily for 3 days or 500 mg Day 1, followed by 250 mg once daily Days 2-5.
Acute bacterial sinusitis: 500 mg once daily for 3 days
Genital ulcer disease (chancroid): 1 g as a single dose
Non-gonoccocal urethritis and cervicitis: 1 g as a single dose
Gonococcal urethritis and cervicitis: 2 g as a single dose
Odazyth® oral suspension for children:
Acute otitis media: 30 mg/kg (0.75ml/kg) single dose or 10 mg/kg (0.25ml/kg) once daily for 3 days or 10 mg/kg Day 1 then 5 mg/kg/day Days 2-5
Acute bacterial sinusitis: 10 mg/kg once daily for 3 days
Community-acquired pneumonia: 10 mg/kg Day 1 then 5 mg/kg/day Days 2-5
Pharyngitis/Tonsillitis: 12 mg/kg once daily for 5 days
Directions for Reconstitution: 15 ml: Add 10 ml boiled & cooled water; 30 ml: Add 20 ml; 50 ml: Add 33.5 ml. Shake well, consume within 5 days.
Antacids containing aluminum and magnesium reduce peak azithromycin absorption; increases serum concentrations of digoxin and colchicine; ergotamine co-administration risks ergotism; monitor INR with warfarin.
Azithromycin is contra-indicated in patients with a known hypersensitivity to Azithromycin or any of the macrolide antibiotics. Because of the theoretical possibility of ergotism, Azithromycin and ergot derivatives should not be co-administered. As liver is the principal route of excretion of Azithromycin, it should not be used in patients with hepatic disease.
Common: Nausea, abdominal pain/cramps, vomiting, flatulence, diarrhea, loose stools. Less Common: Rash, mild transient neutropenia.
Overdose
There are no data on over dosage with Azithromycin. Typical symptoms of over dosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhea. Gastric lavage and general supportive measures are indicated.
Category B. Considered safe for chlamydial and respiratory infections during pregnancy when clearly needed. Lactation: Excreted in human milk in low amounts; caution advised in nursing women.
Store below 25°C in a cool, dry place. Protect from light and moisture. Reconstituted suspension should be consumed within 5 days.