ISOTAMINE POWDER

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ISONIAZID

Dostopno od:

BAUSCH HEALTH, CANADA INC.

Koda artikla:

J04AC01

INN (mednarodno ime):

ISONIAZID

Odmerek:

500G

Farmacevtska oblika:

POWDER

Sestava:

ISONIAZID 500G

Pot uporabe:

ORAL

Enote v paketu:

500G

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTITUBERCULOSIS AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2005-05-05

Lastnosti izdelka

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