PYRAZINAMIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Novitium Pharma LLC

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Pyrazinamide Tablets, USP 500 mg are round, white, scored tablets, debossed "N" above the score and "484" below the score. NDC 70954-484-10 - Bottle of 60 NDC 70954-484-20 - Bottle of 90 NDC 70954-484-30 - Bottle of 100 NDC 70954-484-40 - Bottle of 500 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

PYRAZINAMIDE - PYRAZINAMIDE TABLET
NOVITIUM PHARMA LLC
----------
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: 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 (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.
Approximately 70% of an oral dose is excreted in urine, mainly by
glomerular filtration
within 24 hours.
1
2
1/2
3
3
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 & 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