PYRAZINAMIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

A-S Medication Solutions

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Product: 50090-0521 NDC: 50090-0521-0 100 TABLET in a BOTTLE

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PYRAZINAMIDE- PYRAZINAMIDE TABLET
A-S MEDICATION SOLUTIONS
----------
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.
5
5
3
1
2
3
3
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
recomm