Rx Item-Pyrazinamide 500Mg Tab 100 By Akorn Pharma

PYRAZINAMIDE- pyrazinamide tablet
Mikart, Inc.

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
Each Pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: dibasic calcium phosphate (dihydrate), colloidal silicon dioxide, croscarmellose sodium, 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. 1 Pyrazinamide is approximately 10% bound to plasma proteins. 2 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. 3

Approximately 70% of an oral dose is excreted in the urine, mainly by glomerular filtration within 24 hours. 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 AND 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 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)

RX ITEM-Pyrazinamide 500Mg Tab 100 By Ak
NDC 61748-0012-01 UPC/GTIN No.3-61748-01201-5 Mfg.Part No.1201

Pyrazinamide 500Mg Tab 100 By Akorn Phar
BRAND: PYRAZINAMIDE NDC: 61748-0012-01,61748001201 UPC: 3-61748-01201-5,361748012015 Akorn Inc

PYRAZINAMIDE ORAL TABLET
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