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Zithromax (Azithromycin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ZITHROMAX (azithromycin) is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated microorganisms in the specific conditions listed below.

Sexually Transmitted Diseases

Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

ZITHROMAX, at the recommended dose, should not be relied upon to treat gonorrhea or syphilis. Antimicrobial agents used in high doses for short periods of time to treat non-gonococcal urethritis may mask or delay the symptoms of incubating gonorrhea or syphilis. All patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with ZITHROMAX may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zithromax (azithromycin) and other antibacterial drugs, Zithromax (azithromycin) should be used only to treat or prevent 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.

Mycobacterial Infections

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 Mycobacterium avium complex (MAC) disease in persons with advanced HIV infection. (See DOSAGE AND ADMINISTRATION, CLINICAL STUDIES)

Treatment of Disseminated Mycobacterium avium complex (MAC) Disease

ZITHROMAX, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection. (See DOSAGE AND ADMINISTRATION, 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. 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 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 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.

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.

Renal Insufficiency

No dosage adjustment is recommended for subjects with renal impairment (GFR≤80mL/min). The mean AUC 0–120 was similar in subjects with GFR 10–80 mL/min compared to subjects with normal renal function, whereas it increased 35% in subjects with GFR<10mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment. (See CLINICAL PHARMACOLOGY-Renal Insufficiency.)

Hepatic Insufficiency

The pharmacokinetics of azithromycin in subjects with hepatic impairment have not been established. No dosage adjustment recommendations can be made in patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY-Hepatic Impairment.)

HOW SUPPLIED

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).

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