NALOXONE HYDROCHLORIDE INJECTION, USP SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE DIHYDRATE)

Disponible desde:

STRIDES PHARMA CANADA INC

Código ATC:

V03AB15

Designación común internacional (DCI):

NALOXONE

Dosis:

0.4MG

formulario farmacéutico:

SOLUTION

Composición:

NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE DIHYDRATE) 0.4MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

OPIATE ANTAGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0108981002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2020-08-04

Ficha técnica

Page 1 of 12
PRODUCT MONOGRAPH
Pr
NALOXONE HYDROCHLORIDE INJECTION, USP
Preservative Free
Naloxone Hydrochloride Dihydrate
0.4 mg / mL
Solution for Intravenous, Intramuscular and Subcutaneous use
Opioid Antagonist
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet,
Varennes, QC J3X 1P7
Canada
Date of Preparation:
July 31, 2020
Submission Control No: 241159
Page 2 of 12
Pr
NALOXONE HYDROCHLORIDE INJECTION, USP
Preservative Free
Naloxone Hydrochloride Dihydrate
0.4 mg / mL
THERAPEUTIC CLASSIFICATION
Opioid Antagonist
CLINICAL PHARMACOLOGY
Naloxone
hydrochloride
prevents
or
reverses
the
effects
of
opioids,
including
respiratory
depression, sedation, and hypotension. Also, it can reverse the
psychosomimetic and dysphoric
effects of agonist-antagonists such as pentazocine. Naloxone
hydrochloride is an essentially pure
opioid antagonist, i.e. it does not possess the agonistic or
morphine-like properties characteristic
of other opioid antagonists; naloxone does not produce respiratory
depression, psychosomimetic
effects or pupillary constriction. In the absence of opioids or
agonistic effects of other opioid
antagonists it exhibits essentially no pharmacologic activity.
Naloxone has not been shown to
produce tolerance or to cause physical or psychological dependence. In
the presence of physical
dependence on opioids naloxone will produce withdrawal symptoms.
While the mechanism of action of naloxone is not fully understood, the
preponderance of
evidence suggests that naloxone antagonizes the opioid effects by
competing for the same
receptor sites.
Following parenteral administration naloxone is rapidly distributed in
the body. It is metabolized
in the liver, primarily by glucuronide conjugation, and excreted in
urine.
INDICATIONS AND CLINICAL USE
Naloxone is indicated for the complete or partial reversal of opioid
depression, including
respiratory
depression
induced
by
opioids,
including
natural
and
synthetic
opioids,
propoxyphene, methadone and the agonist-antagonist analgesics
nalbuphine, pentazocine and
butorphanol