Zuellig Pharma
Concise Prescribing Info
Azithromycin dihydrate
Upper & lower resp tract, odontostomatological & skin & soft tissue infections; acute otitis media; infections; uncomplicated genital infections due to Chlamydia trachomatis & non-multiresistant Neisseria gonorrhoeae; chancroid due to Haemophilus ducreyi. In combination w/ ethambutol for treatment of disseminated Mycobacterium avium-intracellulare complex (DMAC) infection in patients w/ advanced HIV. Alone or in combination w/ rifabutin for prophylaxis against MAC infection in advanced HIV-infected patients. IV Community-acquired pneumonia (CAP) caused by susceptible organisms including Legionella pneumophila; pelvic inflammatory disease (PID) caused by Chlamydia trachomatis, N. gonorrhoeae, Mycoplasma hominis.
Dosage/Direction for Use
Oral Adult 500 mg daily for 3 days or 500 mg given on day 1 then 250 mg daily on days 2-5. STD caused by Chlamydia trachomatis & Haemophilus ducreyi 1,000 mg as single dose. STD caused by N. gonorrhoeae Azithromycin 1,000 or 2,000 mg + ceftriaxone 250 or 500 mg. Prophylaxis against MAC infections in HIV-infected patients 1,200 mg once wkly. Treatment of DMAC infections in patients w/ advanced HIV infection 600 mg once daily. Administer in combination w/ ethambutol. Oral susp Childn 10 mg/kg daily for 3 days or 10 mg/kg on day 1 then 5 mg/kg on days 2-5. Total dose: 30 mg/kg. Max recommended total dose: 1,500 mg. Acute otitis media 30 mg/kg single dose as alternative. Ped strep pharyngitis 10 or 20 mg/kg single dose for 3 days. Max daily dose: 500 mg. Inj CAP 500 mg as single daily dose IV for at least 2 days followed by oral azithromycin 500 mg single daily dose to complete 7- to 10-day course of therapy. PID 500 mg single daily dose IV for 1 or 2 days followed by oral azithromycin 250 mg single daily dose to complete 7-day course of therapy.
Cap: Should be taken on an empty stomach: Take 1 hr before or 2 hr after food. Powd for oral susp/Tab: May be taken with or without food.
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic.
Special Precautions
Allergic reactions eg, angioedema, anaphylaxis. Stevens-Johnson syndrome, toxic epidermal necrolysis, & drug reaction w/ eosinophilia & systemic symptoms (DRESS). Severe renal impairment (GFR <10 mL/min), significant hepatic disease. Concomitant use w/ ergot derivatives. Superinfection may occur. Clostridium difficile-associated diarrhoea. Prolonged cardiac repolarization & QT interval in patients at risk of cardiac arrhythmia & Torsades de pointes. Congenital or documented QT prolongation, receiving treatment w/ other active substances known to prolong QT interval eg, antiarrhythmics of class IA & III, antipsychotic agents, antidepressants & fluoroquinolones. Electrolyte disturbance eg, hypokalaemia & hypomagnaesemia; bradycardia, cardiac arrhythmia or insufficiency. Oral susp Diabetes, fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency due to sucrose content. Inj Do not administer as IV bolus or IM. Childn (inj). Pregnancy & lactation. Elderly.
Adverse Reactions
Diarrhea, abdominal pain, nausea, loose stools, flatulence, vomiting, dyspepsia, rash, pruritus & arthralgia; headache, abnormal vision, hearing impairment; transient episodes of mild neutropenia; abnormal liver function; allergic reaction eg, rash & angioedema. Inj Local pain & inflammation at infusion site.
Drug Interactions
Reduced peak serum conc w/ antacids. May elevate serum conc of digoxin. Increased conc of zidovudine. Possible ergotism w/ ergot derivatives. Rhabdomyolysis may occur w/ atorvastatin. Potentiated anticoagulation w/ coumarin-type oral anticoagulants. Elevated Cmax & AUC0-5 w/ cyclosporin. Decreased Cmax w/ fluconazole. Neutropenia may occur w/ rifabutin.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Cap/susp: D; Inj: S
Zithromax tab 250 mg
Zithromax powd for oral susp 200 mg/5 mL
15 mL x 1's
Zithromax powd for inj 500 mg
Zithromax powd for oral susp 100 mg
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