Rx Item-Fomepizole 1G/Ml Vial 1.5Ml By Mylan Institutional

Clinical Information
Gen. Code and Des.
37000 fomepizole INTRAVEN VIAL 1 G/ML
Strength
1 gram/mL
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
92120000 ANTIDOTES
Active Ingredients
7238 fomepizole 7554656



FOMEPIZOLE- fomepizole injection, solution
Mylan Institutional LLC

1.5 g/1.5 mL (1 g/mL)

Sterile

Rx only

Caution: Must be diluted prior to use.

DESCRIPTION

Fomepizole Injection is a competitive inhibitor of alcohol dehydrogenase.

The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C4 H6 N2 and a molecular weight of 82.1. The structural formula is:

Fomepizole Chemical Structure


It is a clear to yellow liquid at room temperature. Its melting point is 25� C (77� F) and it may present in a solid form at room temperature. Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform. Each vial contains 1.5 mL (1 g/mL) of fomepizole.

CLINICAL PHARMACOLOGY

Mechanism of Action
Fomepizole is a competitive inhibitor of alcohol dehydrogenase. 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 byproducts primarily responsible for the metabolic acidosis and renal damage seen in ethylene glycol toxicosis. The lethal dose of ethylene glycol in humans is approximately 1.4 mL/kg.

Methanol, the main component of windshield wiper 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 poisoning. A lethal dose of methanol in humans is approximately 1 to 2 mL/kg. INDICATIONS AND USAGE

Fomepizole injection 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

RX ITEM-Fomepizole 1G/Ml Vial 1.5Ml By M
NDC 67457-0211-02 UPC/GTIN No.3-67457-21102-2 Mfg.Part No.21102

Fomepizole 1G/Ml Vial 1.5Ml By Mylan Ins
BRAND: FOMEPIZOLE NDC: 67457-0211-02,67457021102 UPC: 3-67457-21102-2,367457211022 Mylan Institutional/Gen

FOMEPIZOLE INTRAVEN VIAL
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