Country: Canada
Language: English
Source: Health Canada
ISONIAZID
PENDOPHARM DIVISION OF PHARMASCIENCE INC
J04AC01
ISONIAZID
50MG
SOLUTION
ISONIAZID 50MG
ORAL
500ML
Prescription
ANTITUBERCULOSIS AGENTS
Active ingredient group (AIG) number: 0107349003; AHFS:
APPROVED
2013-12-02
_pdp-ISONIAZID Prescribing Information Page 1 of 12_ _ _ PRESCRIBING INFORMATION PR PDP-ISONIAZID Isoniazid Tablets USP 50 mg, 100 mg, 300 mg Isoniazid Oral Solution USP 50 mg / 5 mL TUBERCULOSIS THERAPY ANTIMYCOBACTERIAL PENDOPHARM, DIVISION OF PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 DATE OF REVISION: November 26, 2020 Submission Control No: 240769 _pdp-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 gene Read the complete document