Land: Canada
Taal: Engels
Bron: Health Canada
FOMEPIZOLE
PALADIN LABS INC.
V03AB34
FOMEPIZOLE
1G
LIQUID
FOMEPIZOLE 1G
INTRAVENOUS
1.5 ML
Prescription
ANTIDOTES
Active ingredient group (AIG) number: 0142261001; AHFS:
APPROVED
2006-07-04
_ _ _Antizol - Product Monograph _ _Page 1 of 30_ PRODUCT MONOGRAPH Including Patient Medication Information PR ANTIZOL ® (fomepizole) Injection 1.5 mL (1 g/mL) Synthetic Alcohol Dehydrogenase Inhibitor Paladin Labs Inc. Date of Revision: October 23, 2017 100 Alexis Nihon Blvd., Suite 600 St-Laurent, Québec H4M 2P2 Version: 6.0 Submission Control No.: CN 207700 ANTIZOL ® is a registered trademark of Paladin Labs Inc. _ _ _Antizol - Product Monograph _ _Page 2 of 30_ P RODUCT N AME ANTIZOL ® (FOMEPIZOLE) INJECTION 1.5 ML (1 G/ML) T HERAPEUTIC C LASSIFICATION Synthetic Alcohol Dehydrogenase Inhibitor A CTION AND C LINICAL P HARMACOLOGY MECHANISM OF ACTION: Antizol (fomepizole) is a competitive inhibitor of alcohol dehydrogenase (ADH). Alcohol dehydrogenase catalyzes the oxidation of ethanol to acetaldehyde. Alcohol dehydrogenase also catalyzes the initial steps in the metabolism of ethylene glycol and methanol to their toxic metabolites. Ethylene glycol, the main component of most antifreezes and coolants, is metabolized to glycoaldehyde, which undergoes subsequent sequential oxidations to yield glycolate, glyoxylate, and oxalate. Glycolate and oxalate are the metabolic by-products primarily responsible for the metabolic acidosis and renal damage seen in ethylene glycol toxicosis which presents with the following morbidities: nausea/vomiting, seizures, cardiac arrhythmias, stupor, coma, calcium oxaluria, acute tubular necrosis and death, depending on the amount of ethylene glycol ingested _ _ _Antizol - Product Monograph _ _Page 3 of 30_ and the time elapsed since ingestion. The lethal dose of ethylene glycol in humans is approximately 1.4 mL/kg. Methanol, the main component of windshield washer fluid, is slowly metabolized via alcohol dehydrogenase to formaldehyde with subsequent oxidation via formaldehyde dehydrogenase to yield formic acid. Formic acid is primarily responsible for the metabolic acidosis and visual disturbances (e.g., decreased visual acuity and potential blindness) associated with methanol po Lees het volledige document