PYRAZINAMIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Macleods Pharmaceuticals Limited

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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 antituberculous agents. *See recommendations of Center for Disease Cont

Produkt oppsummering:

Pyrazinamide Tablets, USP 500 mg are round, white to off white uncoated, scored tablets with notches, debossed "F" above the score and "43" below the score and plain on other side. Tablets are supplied in the following strengths and package configurations: Store at 20° to 25° C (68° F to 77° F); excursions permitted between 15° to 30° C (59° F to 86° F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by: Macleods Pharmaceutical Ltd. Daman, (U.T.), INDIA Revised: December 2022

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

PYRAZINAMIDE - PYRAZINAMIDE TABLET
MACLEODS PHARMACEUTICALS LIMITED
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PYRAZINAMIDE TABLETS, USP 500 MG
DESCRIPTION:
Pyrazinamide, USP 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 USP has the following structural formula:
Each pyrazinamide tablet, USP for oral administration contains 500 mg
of pyrazinamide
and the following inactive ingredients: corn starch, colloidal silicon
dioxide, magnesium
stearate, povidone, sodium starch glycolate and talc.
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
) 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.
1
2
1/2
3
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.
Susceptibility Testing
For specific information regarding susceptibility test interpretive
criteria and associated
test methods and quality control standards recognized by FD