PYRAZINAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRAZINAMIDE (UNII: 2KNI5N06TI) (PYRAZINAMIDE - UNII:2KNI5N06TI)

Available from:

Major Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Contr

Product summary:

Pyrazinamide Tablets, USP 500 mg are round, white, scored tablets, debossed S above the score, 660 below the score. Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6696-61 Bottle of 90 tablets, NDC 0904-6696-89 Bottle of 100 tablets, NDC 0904-6696-60 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PYRAZINAMIDE- PYRAZINAMIDE TABLET
MAJOR PHARMACEUTICALS
----------
PYRAZINAMIDE TABLETS, USP
500 MG
RX ONLY
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 H N 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.
CLINICAL PHARMACOLOGY
Pyrazinamide is well absorbed from the GI tract and attains peak
plasma concentrations within 2 hours.
Plasma concentrations generally range from 30 to 50 mcg/mL with doses
of 20 to 25 mg/kg. It is widely
distributed in body tissues and fluids including the liver, lungs and
cerebrospinal fluid (CSF). The CSF
concentration is approximately equal to concurrent steady-state plasma
concentrations in patients with
inflamed meninges.
Pyrazinamide is approximately 10% bound to plasma proteins.
The half-life (t1/2) of pyrazinamide is 9 to 10 hours in patients with
normal renal and hepatic function.
The plasma half-life may be prolonged in patients with impaired renal
or hepatic function. Pyrazinamide
is hydrolyzed in the liver to its major active metabolite, pyrazinoic
acid. Pyrazinoic acid is hydroxylated
to the main excretory product, 5-hydroxypyrazinoic acid.
Approximately 70% of an oral dose is excreted in urine, mainly by
glomerular filtration within 24
hours.
Pyrazinamide may be bacteriostatic or bactericidal against
_Mycobacterium tuberculosis_ depending on the
concentration of the drug attained at the site of infection. The
mechanism of action is unknown. _In vitro_
and _in vivo _the drug is active only at a slightly acidic pH.
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-