Pyrazinamide

Indications

INDICATIONS AND 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 recommendations 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Pyrazinamide should always be administered with other effective antituberculous drugs. It is administered for the initial 2 months of a 6-month or longer treatment regimen for drug-susceptible patients. Patients who are known or suspected to have drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy. Patients with concomitant HIV infection may require longer courses of therapy. Physicians treating such patients should be alert to any revised recommendations from CDC for this group of patients.

Contraindications

CONTRAINDICATIONS Pyrazinamide is contraindicated in persons: with severe hepatic damage. who have shown hypersensitivity to it. with acute gout.

Warnings and precautions

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.

Pregnancy

Pregnancy Teratogenic Effects – Pregnancy Category C Animal reproduction studies have not been conducted with pyrazinamide. It is also not known whether pyrazinamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyrazinamide should be given to a pregnant woman only if clearly needed.

Storage and supply

HOW SUPPLIED Pyrazinamide Tablets, USP 500 mg are round, white, scored tablets, debossed "N" above the score and "484" below the score. NDC 10135-0735-60 - Bottle of 60 NDC 10135-0735-90 - Bottle of 90 NDC 10135-0735-01 - Bottle of 100 Store at 20° to 25°C (68° to 77°F) .

Source: Pyrazinamide Tablet (Pyrazinamide) — US FDA prescribing information, 2025-12-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.