Oral azithromycin should be administered as a single daily dose. Azithromycin tablets can be taken with or without food.
The period of dosing with regard to other infections is given as follows: In Adults:
For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis and
Hemophilus ducreyi, the dose is 1000 mg as a single oral dose. For susceptible Neisseria
gonorrhoeae, the recommended dose is 1000 mg or 2000 mg of azithromycin in
combination with 250 mg or 500 mg ceftriaxone according to local clinical treatment
guidelines. For patients who are allergic to penicillin and/or cephalosporins, prescribers
should consult local treatment guidelines.
For prophylaxis against MAC infections in patients infected with HIV, the dose is
1200 mg once per week.
For the treatment of DMAC infections in patients with advanced HIV infection, the
recommended dose is 600 mg once a day. Azithromycin should be administered in
combination with other antimycobacterial agents that have shown in vitro activity against
MAC, such as ethambutol, at the approved dose.
For all other indications, including upper and lower respiratory tract infections, in which
the oral formulation is administered, the total dosage of 1500 mg should be given as
500 mg daily for 3 days.
In Children: The maximum recommended total dose for any treatment is 1500 mg for children.
Azithromycin tablets should only be administered to children weighing more than 45 kg.
Safety and efficacy for the prevention of MAC in children have not been established.
Based on pediatric pharmacokinetic data, a dose of 20 mg/kg would be similar to the
adult dose of 1200 mg but with higher Cmax.
Special Populations: In the Elderly:
The same dosage as in adult patients is used in the elderly. Elderly patients may be more
susceptible to the development of torsades de pointes arrhythmia than younger patients
(see Precautions).
In Patients with Renal Impairment:
No dose adjustment is necessary in patients with mild to moderate renal impairment
(GFR 10-80 mL/min). Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR <10 mL/min) (see Pharmacology: Pharmacokinetics under Actions and Precautions).
In Patients with Hepatic Impairment: The same dosage as in patients with normal hepatic function may be used in patients with mild to moderate hepatic impairment (see Precautions).
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