PYRAZINAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

PYRAZINAMIDE

Composition:

PYRAZINAMIDE 500 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PYRAZINAMIDE- PYRAZINAMIDE TABLET
REMEDYREPACK INC.
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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:
Each pyrazinamide tablet for oral administration contains 500 mg of
pyrazinamide and the following
inactive ingredients: colloidal silicon dioxide, croscarmellose
sodium, dibasic calcium phosphate
(dihydrate), microcrystalline cellulose, 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 (t
1/2) 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 the 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. (