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To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
ZITHROMAX is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
Sexually Transmitted Diseases
Prophylaxis Of Disseminated Mycobacterium avium Complex (MAC) Disease
ZITHROMAX, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see DOSAGE AND ADMINISTRATION].
Treatment of Disseminated MAC Disease
ZITHROMAX, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see Use in Specific Populations and Clinical Studies].
DOSAGE AND ADMINISTRATION
[see INDICATIONS AND USAGE]
ZITHROMAX for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. However, increased tolerability has been observed when tablets are taken with food.
Zithromax for oral suspension (single dose 1 g packet) is not for pediatric use. For pediatric suspension see the prescribing information for ZITHROMAX (azithromycin for oral suspension) 100 mg/5 mL and 200 mg/5 mL bottles.
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 ensure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of azithromycin.
Sexually Transmitted Diseases
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 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.
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.
Dosage Forms And Strengths
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 for oral suspension 1000 mg/5 ml is supplied in single-dose packets containing azithromycin dihydrate equivalent to 1 gram of azithromycin.
Storage And Handling
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).
Distributed by: Pfizer Labs, Division of Pfizer Inc., NY, NY 10017. Revised: March 2014
Last reviewed on RxList: 6/23/2014
This monograph has been modified to include the generic and brand name in many instances.
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