ISOTAMINE POWDER

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ISONIAZID

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

J04AC01

INN (International Name):

ISONIAZID

Dosage:

500G

Pharmaceutical form:

POWDER

Composition:

ISONIAZID 500G

Administration route:

ORAL

Units in package:

500G

Prescription type:

Prescription

Therapeutic area:

ANTITUBERCULOSIS AGENTS

Product summary:

Active ingredient group (AIG) number: 0107349006; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-05-05

Summary of Product characteristics

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
ISOTAMINE PREPARATIONS
Isoniazid, USP
Tablets, Powder and Syrup
TUBERCULOSIS THERAPY
Valeant Canada LP
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Date of Revision:
November 1, 2018
Control#: 215272
_Page 2 of 18 _
PRESCRIBING INFORMATION
ISOTAMINE PREPARATIONS
Isoniazid, USP
Tablets, Powder and Syrup
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 distributed into all body tissues and fluids (including
cerebrospinal fluid, pleural and
asciti