FOMEPIZOLE injection, solution

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Fomepizole (UNII: 83LCM6L2BY) (Fomepizole - UNII:83LCM6L2BY)

Disponibbli minn:

Mylan Institutional LLC

INN (Isem Internazzjonali):

Fomepizole

Kompożizzjoni:

Fomepizole 1 g in 1 mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Fomepizole Injection is supplied as a sterile, preservative-free solution for intravenous use as: NDC 67457-211-02 carton containing one single-dose vial which contains 1.5 mL (1 g/mL) of fomepizole Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 1140L100 Revised: 4/2021 MI:FOMEIJ:R5

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

FOMEPIZOLE- FOMEPIZOLE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
----------
FOMEPIZOLE INJECTION
1.5 G/1.5 ML (1 G/ML)
STERILE
RX ONLY
_CAUTION: MUST BE DILUTED PRIOR TO USE. DO NOT USE POLYCARBONATE
SYRINGES OR_
_POLYCARBONATE-CONTAINING NEEDLES (INCLUDING POLYCARBONATE FILTER
NEEDLES)_
_WITH FOMEPIZOLE INJECTION._
DESCRIPTION
Fomepizole Injection is a competitive inhibitor of alcohol
dehydrogenase.
The chemical name of fomepizole is 4-methylpyrazole. It has the
molecular formula
C H N 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 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.
4
6
2
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.
Fomepizole has been sh