Fomepizole

Generic Name: fomepizole

Antidote [EPC]Over-the-Counter (OTC)

Brand Names:

Fomepizole

DESCRIPTION Fomepizole Injection is a competitive inhibitor of alcohol dehydrogenase. The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C 4 H 6 N 2 and a molecular weight of 82.1. The structural formula is: It is a clear to yellow liquid at room temperature. Its melting point is 25°C(77°F) and it may present as solid form at room temperature. Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform.

Overview

DESCRIPTION Fomepizole Injection is a competitive inhibitor of alcohol dehydrogenase. The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C 4 H 6 N 2 and a molecular weight of 82.1. The structural formula is: It is a clear to yellow liquid at room temperature. Its melting point is 25°C(77°F) and it may present as solid form at room temperature. Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform.

Uses

INDICATIONS AND USAGE Fomepizole is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis ( see DOSAGE AND ADMINISTRATION ).

Dosage

DOSAGE AND ADMINISTRATION Do not use polycarbonate syringes or polycarbonate-containing needles (including polycarbonate filter needles) when diluting or administering Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL). Fomepizole can interact with polycarbonate, compromising the integrity of the syringe and/or needle component containing polycarbonate. Treatment Guidelines: If ethylene glycol or methanol poisoning is left untreated, the natural progression of the poisoning leads to accumulation of toxic metabolites, including glycolic and oxalic acids (ethylene glycol intoxication) and formic acid (methanol intoxication). These metabolites can induce metabolic acidosis, nausea/vomiting, seizures, stupor, coma, calcium oxaluria, acute tubular necrosis, blindness, and death.

Side Effects

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 fomepizole injection were headache ( 14% ), nausea (11%), and dizziness, increased drowsiness, and bad taste / metallic taste (6% each). All other adverse events in this population were reported in approximately 3% or fewer of those receiving fomepizole and were as follows: Body as a Whole: Abdominal pain, fever, multiorgan system failure, pain during fomepizole injection, inflammation at injection site, lumbalgia/backache, hangover. Cardiovascular: Sinus bradycardia/bradycardia, phlebosclerosis, tachycardia, phlebitis, shock, hypotension.

Warnings

CONTRAINDICATIONS Fomepizole should not be administered to patients with a documented serious hypersensitivity reaction to fomepizole or other pyrazoles.

Storage

HOW SUPPLIED Fomepizole Injection is available as a sterile, preservative-free solution for intravenous use, in vials containing1.5mL (1 g/mL) of fomepizole. Fomepizole injection is supplied in cartons of one single use vial (NDC 70710-1478-1) Store at controlled room temperature, 20° to 25°C (68° to 77°F). Distributed by: Zydus Pharmaceuticals USA Inc.

Frequently Asked Questions

What is Fomepizole used for?

INDICATIONS AND USAGE Fomepizole is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis ( see DOSAGE AND ADMINISTRATION ).

What are the side effects of Fomepizole?

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 fomepizole injection were headache ( 14% ), nausea (11%), and dizziness, increased drowsiness, and bad taste / metallic taste (6% each). All other adverse events in this population were reported in approximately 3% or fewer of those receiving fomepizole and were as follows: Body as a Whole: Abdominal pain, fever, multiorgan system failure, pain during fomepizole injection, inflammation at injection site, lumbalgia/backache, hangover. Cardiovascular: Sinus bradycardia/bradycardia, phlebosclerosis, tachycardia, phlebitis, shock, hypotension.

What are the important warnings for Fomepizole?

CONTRAINDICATIONS Fomepizole should not be administered to patients with a documented serious hypersensitivity reaction to fomepizole or other pyrazoles.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.