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Drug Catalog - Product Detail

PYRAZINAMIDE TB 500MG 100

NDC Mfr Size Str Form
67253-0660-10 PAR PHARMACEUTICAL 100 500MG TABLET
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Description
DESCRIPTION Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula: C 5 H 5 N 3 O M.W. 123.11 Each Pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: Corn Starch, Magnesium Stearate, Pregelatinized Starch and Stearic Acid. PYRAZINAMIDE Structural Formula
How Supplied
HOW SUPPLIED Pyrazinamide Tablets, USP 500 mg are round, white, scored tablets, debossed S above the score, 660 below the score. NDC 67253-660-10 - Bottle of 100 NDC 67253-660-50 - Bottle of 500 Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Indications & Usage
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. *See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations. 4
Dosage and Administration
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. Usual dose: Pyrazinamide is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 to 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 70 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. The table is taken from the CDC-American Thoracic Society joint recommendations: 4 Recommended Drugs for the Initial Treatment of Tuberculosis in Children and Adults Daily Dose* Maximal Daily Dose in Children and Adults Twice Weekly Dose Drug Children Adults Children Adults Isoniazid 10 to 20 mg/kg PO or IM 5 mg/kg PO or IM 300 mg 20 to 40 mg/kg Max. 900 mg 15 mg/kg Max. 900 mg Rifampin 10 to 20 mg/kg PO 10 mg/kg PO 600 mg 10 to 20 mg/kg Max. 600 mg 10 mg/kg Max. 600 mg Pyrazinamide 15 to 30 mg/kg PO 15 to 30 mg/kg PO 2 g 50 to 70 mg/kg 50 to 70 mg/kg Streptomycin 20 to 40 mg/kg IM 15 mg/kg** IM 1 g** 25 to 30 mg/kg IM 25 to 30 mg/kg IM Ethambutol 15 to 25 mg/kg PO 15 to 25 mg/kg PO 2.5 g 50 mg/kg 50 mg/kg Definition of abbreviations: PO = perorally; IM = intramuscularly. * Doses based on weight should be adjusted as weight changes. **In persons older than 60 yrs of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.