Zithromax

[Azithromycin]

Treatment of Disseminated MAC Infections ZITHROMAX should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/ kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.

DIRECTIONS FOR ADMINISTRATION OF ZITHROMAX ® for oral suspension in the single dose packet (1 g): The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to assure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of azithromycin. This packet not for pediatric use.

HOW SUPPLIED

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ZITHROMAX ® capsules (imprinted with "Pfizer 305") are supplied in red opaque hard-gelatin capsules containing azithromycin dihydrate equivalent to 250 mg of azithromycin. These are packaged in bottles and blister cards of 6 capsules (Z-PAKS®) as follows:

Bottles of 50 NDC 0069-3050-50 Boxes of 3 (Z-PAKS® of 6) NDC 0069-3050-34
Unit Dose package of 50 NDC 0069-3050-86
Store capsules below 30 C (86 F).
ZITHROMAX ® 600 mg tablets (engraved on front with "PFIZER" and on back with "308") are supplied as white, modified oval-shaped, film-coated tablets containing azithromycin dihydrate equivalent to 600 mg azithromycin. These are packaged in bottles of 30 tablets. ZITHROMAX ® tablets are supplied as follows:
Bottles of 30 NDC 0069-3080-30
Tablets should be stored at or below 30 C (86 F).
ZITHROMAX ® for oral suspension is supplied in single dose packets containing azithromycin dihydrate equivalent to 1 gram of azithromycin as follows:

Boxes of 10 Single Dose Packets (1 g) NDC 0069-3051-07 Boxes of 3 Single Dose Packets (1 g) NDC 0069-3051-75
Store single dose packets between 5 and 30 C (41 and 86 F).
CLINICAL STUDIES IN PATIENTS WITH ADVANCED HIV INFECTION FOR THE PREVENTION AND TREATMENT OF DISEASE DUE TO DISSEMINATED MYCOBACTERIUM AVIUM COMPLEX (MAC) (See INDICATIONS AND USAGE):

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