Страна: Канада
Язык: английский
Источник: Health Canada
ISONIAZID
BAUSCH HEALTH, CANADA INC.
J04AC01
ISONIAZID
100MG
TABLET
ISONIAZID 100MG
ORAL
100/1000
Prescription
ANTITUBERCULOSIS AGENTS
Active ingredient group (AIG) number: 0107349002; AHFS:
APPROVED
2005-05-05
PRESCRIBING INFORMATION INCLUDING PATIENT MEDICATION INFORMATION PR ISOTAMINE ® Isoniazid, USP 100 mg and 300 mg Tablets 10 mg/mL Syrup Powder ANTITUBERCULOSIS AGENT BAUSCH HEALTH, CANADA INC. DATE OF REVISION: 2150 St-Elzear Blvd. West December 7, 2020 Laval, Quebec H7L 4A8 Control No.: 245927 _Pr_ _ISOTAMINE _ _®_ _ Prescribing Information Page 2 of 19_ PRESCRIBING INFORMATION PR ISOTAMINE ® Isoniazid, USP 100 mg and 300 mg Tablets 10 mg/mL Syrup Powder ACTION Isoniazid may be bacteriostatic or bactericidal in action, depending on the concentration of the drug attained at the site of infection and the susceptibility of the infecting organism. The exact mechanism of action of isoniazid has not been fully elucidated, but several mechanisms including interference with metabolism of bacterial proteins, nucleic acids, carbohydrates, and lipids have been proposed. One of the principal actions of the drug appears to be inhibition of mycolic acid synthesis in susceptible bacteria which results in loss of acid-fastness and disruption of the bacterial cell wall. Isoniazid is active against susceptible bacteria only when they are undergoing cell division. Susceptible bacteria may undergo 1 or 2 divisions before multiplication is arrested. SPECTRUM Isoniazid is a highly specific agent and is active only against organisms of the genus Mycobacterium. Isoniazid is active _in vitro_ and _in vivo_ against M. tuberculosis, M. bovis, and some strains of M. kansasii. _In vitro_, the minimum inhibitory concentration (MIC) for most susceptible mycobacteria is 0.02-0.2 mcg/mL in Lowenstein-Jensen media. CLINICAL PHARMACOLOGY ABSORPTION Isoniazid is readily absorbed from the GI tract. When given with food, the extent of absorption and peak plasma concentrations of the drug may be reduced. Following oral application of the drug, peak plasma concentrations are attained within 1-2 hours. Plasma concentrations of the drug in rapid isoniazid inactivators are 20-50 % of those in slow isoniazid inactivators. DISTRIBUTION Isoniazid is dist Прочитать полный документ