ANTIZOL LIQUID

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

FOMEPIZOLE

Dostopno od:

PALADIN LABS INC.

Koda artikla:

V03AB34

INN (mednarodno ime):

FOMEPIZOLE

Odmerek:

1G

Farmacevtska oblika:

LIQUID

Sestava:

FOMEPIZOLE 1G

Pot uporabe:

INTRAVENOUS

Enote v paketu:

1.5 ML

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTIDOTES

Povzetek izdelek:

Active ingredient group (AIG) number: 0142261001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2006-07-04

Lastnosti izdelka

_ _
_Antizol - Product Monograph _
_Page 1 of 30_
PRODUCT MONOGRAPH
Including Patient Medication Information
PR
ANTIZOL
®
(fomepizole) Injection
1.5 mL (1 g/mL)
Synthetic Alcohol Dehydrogenase Inhibitor
Paladin Labs Inc.
Date of Revision: October 23, 2017
100 Alexis Nihon Blvd., Suite 600
St-Laurent, Québec
H4M 2P2
Version: 6.0
Submission Control No.: CN 207700
ANTIZOL
®
is a registered trademark of Paladin Labs Inc.
_ _
_Antizol - Product Monograph _
_Page 2 of 30_
P
RODUCT
N
AME
ANTIZOL
®
(FOMEPIZOLE) INJECTION
1.5 ML (1 G/ML)
T
HERAPEUTIC
C
LASSIFICATION
Synthetic Alcohol Dehydrogenase Inhibitor
A
CTION AND
C
LINICAL
P
HARMACOLOGY
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
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 by-products
primarily responsible for the
metabolic acidosis and renal damage seen in ethylene glycol toxicosis
which presents with the
following morbidities: nausea/vomiting, seizures, cardiac arrhythmias,
stupor, coma, calcium
oxaluria, acute tubular necrosis and death, depending on the amount of
ethylene glycol ingested
_ _
_Antizol - Product Monograph _
_Page 3 of 30_
and the time elapsed since ingestion. The lethal dose of ethylene
glycol in humans is
approximately 1.4 mL/kg.
Methanol, the main component of windshield washer 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
po