国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
PYRAZINAMIDE (UNII: 2KNI5N06TI) (PYRAZINAMIDE - UNII:2KNI5N06TI)
Macleods Pharmaceuticals Limited
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
PYRAZINAMIDE - PYRAZINAMIDE TABLET MACLEODS PHARMACEUTICALS LIMITED ---------- 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 完全なドキュメントを読む