Azithromycin tablets are 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.

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Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Azithromycin tablets are contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic.

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Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Rare serious allergic reactions, including angioedema and anaphylaxis, have been reported rarely in patients on azithromycin therapy.

(See CONTRAINDICATIONS).

Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure.

These patients required prolonged periods of observation and symptomatic treatment.

The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown at present.If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.

Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile.

C.

difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C.

difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.

difficile, and surgical evaluation should be instituted as clinically indicated.

The following US Branded drugs contain Azithromycin

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ZITHROMAX -- PFIZER CHEMICALS DIV PFIZER INC

ZMAX -- PFIZER GLOBAL RESEARCH DEVELOPMENT

ZITHROMAX -- PFIZER CENTRAL RESEARCH

ZITHROMAX -- PFIZER INC

AZASITE -- INSPIRE PHARMACEUTICALS INC