Pyrazinamide is indicated for the initial treatment of active tubercuIosis in adults and children when combined with other antitubercu-lous 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 antituber-culous agents.

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.

Usual dose: Pyrazinamide is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 or 4 divided doses daily, but most current recommendations are for once a day. Three grams per day should not be exceeded. The CDC recommendations do not exceed 2 g per day when given as a daily regimen (see table).

Alternatively, a twice weekly dosing regimen (50 to 75 mg/kg twice weekly based on lean body weight) has been developed to promote patient compliance with a regimen on an outpatient basis. In studies evaluating the twice weekly regimen, doses of pyrazinamide in excess of 3 g twice weekly have been administered. This exceeds the recommended maximum 3 g/daily dose. However, an increased incidence of adverse reactions has not been reported.

This table is taken from the CDC-American Thoracic Society joint recommendations.⁴

Recommended Drugs for the Initial Treatment of Tuberculosis in Children and Adults

Pyrazinamide Tablets USP contain pyrazinamide 500 mg. They are supplied as white, round, scored tablets debossed “VP/012”

in containers of 60 tablets NDC 61748-012-06,
in containers of 90 tablets NDC 61748-012-09,
in containers of 100 tablets NDC 61748-012-01,
in containers of 500 tablets NDC 61748-012-05,
and in hospital unit-dose cartons of 100 tablets (in strips of 10 tablets per strip) NDC 61748-012-11.

Storage: Store in a well-closed container at controlled room temperature, 15°C to 30°C (59°F to 86°F).

Dispense in a well-closed container with a child-resistant closure.

REFERENCES

*See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.⁴

4. Treatment of tuberculosis and tuberculosis infection in adults and children. Am Rev Respir Dis. 1986 ; 134 : 363-368.

Marketed by: VersaPharm Incorporated, Marietta, GA 30062. Manufactured by: MIKART INC., Atlanta, GA 30318. Rev. 04/01. FDA revision date: 8/13/2002

Last reviewed on RxList: 12/3/2008
This monograph has been modified to include the generic and brand name in many instances.