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Zithromax

[Azithromycin]

Geriatric Patients with Opportunistic Infections, Including Mycobacterium avium complex (MAC) Disease

Safety data are available for 30 patients (65-94 years old) treated with azithromycin at doses >300 mg/ day for a mean of 207 days. These patients were treated for a variety of opportunistic infections, including MAC. The side effect profile was generally similar to that seen in younger patients, except for a higher incidence of side effects relating to the gastrointestinal system and to reversible impairment of hearing. (See DOSAGE AND ADMINISTRATION.)

DOSAGE AND ADMINISTRATION

Text Continues Below



(See INDICATIONS AND USAGE.)

ZITHROMAX ® capsules should be given at least 1 hour before or 2 hours after a meal. ZITHROMAX ® capsules should not be mixed with or taken with food.

ZITHROMAX ® for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. Not for pediatric use. For pediatric suspension, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for ZITHROMAX (azithromycin for oral suspension) 100 mg/ 5 mL and 200 mg/ 5 mL bottles.

ZITHROMAX ® tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.

The recommended dose of ZITHROMAX ® or the treatment of individuals 16 years of age and older with mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease, pneumonia, pharyngitis/ tonsillitis (as second line therapy), and uncomplicated skin and skin structure infections due to the indicated organisms is: 500 mg as a single dose on the first day followed by 250 mg once daily on Days 2 through 5 for a total dose of 1.5 grams of ZITHROMAX ® .

The recommended dose of ZITHROMAX ® for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is: a single 1 gram (1000 mg) dose of ZITHROMAX ® . This dose can be administered as four 250 mg capsules or as one single dose packet (1 g). Prevention of Disseminated MAC Infections The recommended dose of ZITHROMAX® for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of ZITHROMAX® may be combined with the approved dosage regimen of rifabutin.

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