ANTIZOL Solution for injection (2017)
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Περιεχόμενα
Name of the medicinal product
Antizol (fomepizole) Injection 1.5 mL (1 g/mL).
Indications and clinical use
Antizol (fomepizole) Injection is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol (such as windshield washer fluid) poisoning, or for use in suspected ethylene glycol or methanol ...
Contraindications
Antizol (fomepizole) Injection should not be administered to patients with a documented serious hypersensitivity reaction to Antizol or other pyrazoles.
Warnings and precautions
General Antizol (fomepizole) Injection should not be given undiluted or by bolus injection. Venous irritation and phlebosclerosis were noted in two of six normal volunteers given bolus injections of Antizol ...
Adverse reactions
The most frequent adverse events reported as drug-related or unknown relationship to study drug in the 78 patients and 63 normal volunteers who received Antizol (fomepizole) Injection were headache (14%), ...
Drug interactions
Oral doses of Antizol (10-20 mg/kg) significantly reduced the rate of elimination of ethanol (by approximately 40%), via alcohol dehydrogenase inhibition, when given to healthy volunteers in moderate doses. ...
Dosage and administration
Treatment Guidelines Treatment of ethylene glycol and methanol poisonings consist of blocking the formation of toxic metabolites using inhibitors of alcohol dehydrogenase, such as Antizol (fomepizole) ...
Overdosage
Nausea, dizziness, and vertigo were noted in healthy volunteers receiving 50 and 100 mg/kg doses of Antizol (fomepizole) Injection (at plasma concentrations of 290-520 mcmol/L, 23.8-42.7 mg/L). These doses ...
Action and clinical pharmacology
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 ...
Dosage forms, composition and packaging
Antizol (fomepizole) Injection is supplied as a sterile, preservative-free solution for intravenous use. Each package contains four vials, each vial containing 1.5 mL (1 g/mL) of Antizol (fomepizole) Injection. ...
Pharmaceutical information
Drug Substance Common name: fomepizole Chemical name: 4-methylpyrazole Structural formula Molecular Formula: C<sub>4</sub>H<sub>6</sub>N<sub>2</sub> Molecular weight: 82.1 Description: Fomepizole is a ...
Detailed pharmacology
Animal Studies Fomepizole has been shown in vitro and in vivo to block alcohol dehydrogenase enzyme activity in dog, monkey, and human liver. The relative affinity of fomepizole for human ADH is 80,000 ...
Clinical trials
Clinical studies demonstrate that fomepizole is rapidly and widely distributed to the total body water after IV infusion and undergoes non-linear Michealis-Menten elimination kinetics after a single dose. ...
Toxicology
Acute Toxicity An acute toxicology study has been conducted in the mouse and rat over the dose range of 0.75 to 2.00 g/kg. The oral LD<sub>50</sub> (lethal dose, 50%) of fomepizole in the mouse and rat ...
Marketing authorization holder
Paladin Labs Inc., 100 Alexis Nihon Blvd., Suite 600, St-Laurent, Québec, H4M 2P2
Submission control number
CN 207700
Date of revision
October 23, 2017
References
Barceloux DG, et al. American Academy of Clinical Toxicology Practice Guidelines on the Treatment of Ethylene Glycol Poisoning. Ad Hoc Committee. J Tox Clin Tox 1999; 37(5):537-60. Baud, FJ, Bismuth C, ...
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