Zmax is 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. Please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.

Adults

Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae, in patients appropriate for oral therapy. (See CLINICAL STUDIES.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zmax and other antibacterial drugs, Zmax 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.

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

(See INDICATIONS AND USAGE and CLINICAL PHARMACOLOGY.)

Zmax should be taken as a single 2.0 g dose. Zmax provides a full course of antibacterial therapy in a single oral dose. It is recommended that Zmax be taken on an empty stomach (at least 1 hour before or 2 hours following a meal).

In the Phase 3 program, no patient vomited within 5 minutes of dosing Zmax. In the event that a patient vomits within 5 minutes of administration, the health care provider should consider additional antibiotic treatment since there would be minimal absorption of azithromycin. Since insufficient data exist on absorption of azithromycin if a patient vomits between 5 and 60 minutes following administration, alternative therapy should be considered. Neither a second dose of Zmax nor alternative treatment is warranted if vomiting occurs ≥ 60 minutes following administration, in patients with normal gastric emptying.

Instructions for Pharmacist

Constitute with 60 mL of water and replace cap. Shake bottle well before dispensing.

Special Populations

Renal Insufficiency

No dosage adjustment is recommended for patients with renal impairment (GFR 10-80 mL/min). Caution should be exercised when Zmax is administered to patients with end-stage renal disease (GFR < 10 mL/min). (See CLINICAL PHARMACOLOGY - Special Populations - Renal Insufficiency.)

Hepatic Insufficiency

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

Zmax is supplied in bottles (NDC 0069-4170-21) containing 2.0 g of azithromycin and should be constituted with 60 mL of water. See DOSAGE AND ADMINISTRATION for constitution instructions.

Storage

Before constitution, store dry powder at or below 30°C (86°F).

After constitution, store suspension at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze.

Constituted suspension should be consumed within 12 hours.

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