Zuellig Pharma
Concise Prescribing Info
Azithromycin dihydrate
Oral: Lower resp tract infections including bronchitis & pneumonia; skin & soft tissue infections; acute otitis media; upper resp tract infections including sinusitis & pharyngitis/tonsillitis. Uncomplicated genital infections due to Chlamydia trachomatis & non-multiresistant Neisseria gonorrhoea. Chancroid due to H ducreyi. Infusion: Community-acquired pneumonia (CAP) & pelvic inflammatory disease (PID) in patients who require initial IV therapy.
Dosage/Direction for Use
Tab/powd for oral susp Adult STD caused by C trachomatis or susceptible N gonorrhoea & chancroid due to H ducreyi 1,000 mg as single dose. All other indications 500 mg daily for 3 days or 500 mg on day 1, then 250 mg on days 2-5. Childn Total dose: 30 mg/kg given as 10 mg/kg single daily dose for 3 days or 10 mg/kg daily over 5 days w/ 10 mg/kg on day 1, then 5 mg/kg on days 2-5. Acute otitis media Alternative dosing: 30 mg/kg single dose. Ped Strep pharyngitis 10 or 20 mg/kg as single dose for 3 days. Max: Not to exceed 500 mg daily. Infusion Adult CAP 500 mg IV single daily dose for at least 2 days, followed by 500 mg PO single daily dose to complete 7-10-day course. PID 500 mg IV single daily dose for 1-2 days, followed by 250 mg PO single daily dose to complete 7-day course.
May be taken with or without food: May be taken w/ meals to reduce GI discomfort.
Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides.
Special Precautions
Not to be used as IV bolus or IM inj. Discontinue use if allergic reaction, signs & symptoms of hepatitis occur. Superinfection; Clostridium difficile-associated diarrhea. Congenital or documented QT prolongation, electrolyte disturbance, clinically relevant bradycardia, cardiac arrhythmia or insufficiency. Myasthenia gravis exacerbation. Not to be co-administered w/ ergot derivatives. Concurrent use w/ drugs prolonging QT interval eg, class IA & III antiarrhythmics, antipsychotics, antidepressants, fluoroquinolones. Severe renal impairment. Pregnancy & lactation. Infantile hypertrophic pyloric stenosis in neonates treated up to 42 days of life. Elderly. Powd for oral susp: Not to be used in fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency.
Adverse Reactions
Mild neutropenia; hearing impairment; nausea, vomiting, diarrhea, loose stools, abdominal discomfort (pain/cramps), flatulence; abnormal liver function; allergic reactions including rash, angioedema. Infusion: Local pain & inflammation at infusion site.
Drug Interactions
Reduced peak serum conc w/ antacids. Increased serum levels of P-gp substrates eg, digoxin or colchicine. Ergotism w/ ergot derivatives. Rhabdomyolysis w/ statins. Monitor prothrombin time w/ coumarin-type oral anticoagulants. Monitor cyclosporin levels.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Zithromax FC tab 250 mg
Zithromax powd for infusion 500 mg
10 mL x 10 × 1's
Zithromax powd for oral susp 200 mg/5 mL
15 mL x 1's
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