Zithromax is supplied for oral administration as film-coated, modified capsular shaped tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin and D&C Red #30 aluminum lake. For oral suspension it is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla and banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.

Zithromax 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. Zithromax 250 mg tablets are engraved with "PFIZER" on one side and "306" on the other. These are packaged in bottles and blister cards of 6 tablets as follows:

• Bottles of 30 - NDC 0069-3060-30
• Boxes of 3 (Z-PAKS® of 6) - NDC 0069-3060-75
• Unit Dose package of 50 - NDC 0069-3060-86

Zithromax 500 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin. 500 mg tablets are engraved with "Pfizer" on one side and "ZTM500" on the other. These are packaged in bottles and blister cards of 3 tablets as follows:

• Bottles of 30 - NDC 0069-3070-30
• Boxes of 3 (TRI-PAKSTM of 3 tablets) - NDC 0069-3070-75
• Unit Dose package of 50 - NDC 0069-3070-86

The tablets should be stored between 15° to 30°C (59° to 86°F).

To reduce the development of drug-resistant bacteria maintain the effectiveness of Zithromax (azithromycin) and other antibacterial drugs, it should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

At the recommended dose, should not be relied upon to treat 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 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.

In renal insufficiency, no dosage adjustment is recommended for subjects with renal impairment (GFR ≤ 80 mL/min). The mean AUC0-120 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 < 10 mL/min compared to subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment.

For pediatric patients in oral suspension can be taken with or without food. Acute Otitis Media: The recommended dose of Zithromax for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5.

Acute Bacterial Sinusitis: The recommended dose for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. Community-Acquired Pneumonia: The recommended dose for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5.