ISOTAMINE B 300 TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ISONIAZID; PYRIDOXINE HYDROCHLORIDE

Διαθέσιμο από:

BAUSCH HEALTH, CANADA INC.

Φαρμακολογική κατηγορία (ATC):

J04AC51

INN (Διεθνής Όνομα):

ISONIAZID, COMBINATIONS

Δοσολογία:

300MG; 15MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ISONIAZID 300MG; PYRIDOXINE HYDROCHLORIDE 15MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/1000

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTITUBERCULOSIS AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0207350001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2005-05-05

Αρχείο Π.Χ.Π.

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
ISOTAMINE
® B 300
Isoniazid and Pyridoxine Hydrochloride Tablets
300 mg / 15 mg Tablets
ANTITUBERCULOSIS AGENT
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
December 14, 2020
Laval, Quebec
H7L 4A8
Control No.: 245977
_Pr_
_ISOTAMINE_
_®_
_ B 300 Prescribing Information Page 2 of 20_
PR
ISOTAMINE
® B 300
Isoniazid and Pyridoxine Hydrochloride Tablets
300 mg / 15 mg Tablets
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