ANTIZOL- fomepizole injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

FOMEPIZOLE (UNII: 83LCM6L2BY) (FOMEPIZOLE - UNII:83LCM6L2BY)

Pieejams no:

PALADIN LABORATORIES (USA) INC

SNN (starptautisko nepatentēto nosaukumu):

FOMEPIZOLE

Kompozīcija:

FOMEPIZOLE 1 g in 1 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Antizol®  is supplied as a sterile, preservative-free solution for intravenous use as: Supplied in packages of four vials or one vial. Each vial contains 1.5 mL (1 g/mL) of fomepizole. NDC 46129-200-02 (four vials) NDC 46129-200-01 (one vial) Store at controlled room temperature, 20° to 25° C (68° to 77° F) Distributed in the U.S. by: Paladin Labs (USA) Inc.

Autorizācija statuss:

New Drug Application

Produkta apraksts

ANTIZOL- FOMEPIZOLE INJECTION
PALADIN LABORATORIES (USA) INC
----------
Sterile
Rx Only
_CAUTION: MUST BE DILUTED PRIOR TO USE._
DESCRIPTION
Antizol
(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 as
solid 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: Antizol
(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 1-2 mL/kg.
Fomepizole has been shown _in vitro_ to block alcohol dehydrogenase
enzyme activity in dog, monkey,
and human liver. The concentration of fomepizole at which alcohol
dehydrogenase is inhibited by 50%
_in vitr