ISOTAMINE SYRUP

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ISONIAZID

Dostopno od:

BAUSCH HEALTH, CANADA INC.

Koda artikla:

J04AC01

INN (mednarodno ime):

ISONIAZID

Odmerek:

10MG

Farmacevtska oblika:

SYRUP

Sestava:

ISONIAZID 10MG

Pot uporabe:

ORAL

Enote v paketu:

500ML

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTITUBERCULOSIS AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0107349003; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-12-07

Lastnosti izdelka

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