Contents: Azithromycin dihydrate

Treatment of resp tract infections (including otitis media), skin & soft tissue infections & in uncomplicated genital infections. Prophylaxis of Mycobacterium avium complex (MAC) infections.

Dosage: Adult Lower resp tract infection 500 mg once daily for 3 days or as alternative 500 mg on day 1 followed by 250 mg once daily on days 2-5. Upper resp tract infection 500 mg once daily for 3 days. Community-acquired pneumonia 500 mg once daily for 3 days or as alternative 500 mg bid on day 1 followed by 500 mg once daily for 4 days. Skin infections 500 mg as single dose on day 1 followed by 250 mg once daily for 4 days. Nongonococcal urethritis & cervicitis caused by Chlamydia trachomatis in STD 1,000 mg as single dose. Prophylaxis against MAC infections in patients infected w/ HIV 1,200 mg once wkly. Childn >45 kg 30 mg/kg total dose. Max total dose: 1,500 mg. Total dose of 30 mg/kg given as single daily dose of 10 mg/kg daily for 3 days or given over 5 days w/ single daily dose of 10 mg/kg on day 1, then 5 mg/kg on days 2-5. Acute otitis media As alternative, may be given as single dose of 30 mg/kg. Streptococcal pharyngitis Single dose of 10 or 20 mg/kg for 3 days. Max: 500 mg daily.

May be taken with or without food: May be taken w/ meals to reduce
GI discomfort.

Hypersensitivity to azithromycin or any macrolide antibiotics. Childn <45 kg. Concomitant use w/ ergot derivatives.

Special Precautions
: Rarely, severe hypersensitivity reactions may be prolonged. Transient reduction in neutrophil count. Pregnancy & lactation.

Adverse Drug Reactions
: GI disturbances.

Drug Interactions
: Carbamazepine, corticosteroids, cyclosporine, digoxin, ergot alkaloids, theophylline & warfarin. Antacids.

Pregnancy Category (US FDA):
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

MIMS Class:

ATC Classification
: J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.

Regulatory Classification: Rx

Form: Zithrocare 500 film-coated tab 500 mg, 2s, 3s
Reference: mims

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