PMS-ISONIAZID SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ISONIAZID

Available from:

PHARMASCIENCE INC

ATC code:

J04AC01

INN (International Name):

ISONIAZID

Dosage:

50MG

Pharmaceutical form:

SOLUTION

Composition:

ISONIAZID 50MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTITUBERCULOSIS AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-04-12

Summary of Product characteristics

_pms-ISONIAZID Prescribing Information Page 1 of 12_
_ _
PRESCRIBING INFORMATION
PR
PMS-ISONIAZID
Isoniazid Tablets USP
50 mg, 100 mg, 300 mg
Isoniazid Oral Solution USP
50 mg / 5 mL
TUBERCULOSIS THERAPY
ANTIMYCOBACTERIAL
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF INITIAL AUTHORIZATION:
April 12, 2021
Submission Control No: 247000
_pms-ISONIAZID Prescribing Information Page 2 of 12_
_ _
PHARMACOLOGY
Isoniazid is a bactericidal agent active only against organisms of the
genus _Mycobacterium_,
specifically, M_. tuberculosis_, _M. avium intracellulare_, _M. bovis_
and some strains of _M. kansasii_. It
is a highly specific agent, ineffective against other microorganisms.
The mode of action is
unknown, but the drug is firmly bound to actively growing, sensitive
tubercle bacilli and does not
affect these organisms when they are in the metabolic resting state.
When used alone in the treatment of tuberculosis, resistant strains
emerge very rapidly; when
combined with other tuberculostatic drugs; the emergence of resistant
strains may be delayed or
prevented. When isoniazid is used alone in the prophylaxis of
tuberculosis, the development of
resistance does not appear to be a major problem.
PHARMACOKINETICS
Isoniazid is rapidly and almost completely absorbed, when administered
either orally or i.m. and
peak blood levels are reached in about 1 to 2 hours. Bioavailability
is reduced when isoniazid is
administered with food. It diffuses readily into all body fluids
(including cerebrospinal, pleural, and
ascitic), tissues, organs and excreta (saliva, sputum and feces). The
drug also passes through the
placental barrier and into milk in concentrations comparable to those
in the plasma. Isoniazid is
< 10% bound to plasma proteins.
Isoniazid is metabolized by the liver mainly by acetylation and
dehydrazination. The N-
acetylhydrazine metabolite is believed to be responsible for the
hepatotoxic effects seen in patients
treated with isoniazid. The rate of acetylation is genetically
determ