INDICATIONS & USAGE: Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents.

(The current recommendation of the CDC for drug- susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.* 4 ) (Patients with drug-resistant disease should be treated with regimens individualized to their situation.

Pyrazinamide frequently will be an important component of such therapy.) (In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC.

It is possible these patients may require a longer course of treatment).

It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis.

Pyrazinamide should only be used in conjunction with other effective antituberculous agents.

*See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.

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WARNINGS: Patients started on pyrazinamide should have baseline serum uric acid and liver function determinations.

Those patients with preexisting liver disease or those at increased risk for drug related hepatitis (e.g.,alcohol abusers) should be followed closely.

Pyrazinamide should be discontinued and not be resumed if signs of hepatocellular damage or hyperuricemia accompanied by an acute gouty arthritis appear.

ADVERSE REACTIONS: General: Fever, porphyria and dysuria have rarely been reported.

Gout (see PRECAUTIONS: ).

Gastrointestinal: The principal adverse effect is a hepatic reaction (see WARNINGS:).

Hepatotoxicity appears to be dose related, and may appear at any time during therapy.

GI disturbances including nausea, vomiting and anorexia have also been reported.

Hematologic and Lymphatic: Thrombocytopenia and sideroblastic anemia with erythroid hyperplasia, vacuolation of erythrocytes and increased serum iron concentration have occurred rarely with this drug.

Adverse effects on blood clotting mechanisms have also been rarely reported.

Other: Mild arthralgia and myalgia have been reported frequently.

Hypersensitivity reactions including rashes, urticaria, and pruritis have been reported.

Fever, acne, photosensitivity, porphyria, dysuria and interstitial nephritis have been reported rarely.