NALOXONE HYDROCHLORIDE injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)

Disponible desde:

REMEDYREPACK INC.

Designación común internacional (DCI):

NALOXONE HYDROCHLORIDE

Composición:

NALOXONE HYDROCHLORIDE 1 mg in 1 mL

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION
REMEDYREPACK INC.
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NALOXONE HYDROCHLORIDE
INJECTION, USP
OPIOID ANTAGONIST
Rx Only
DESCRIPTION
Naloxone hydrochloride, an opioid antagonist, is a synthetic congener
of oxymorphone. In structure it
differs from oxymorphone in that the methyl group on the nitrogen atom
is replaced by an allyl group.
NALOXONE HYDROCHLORIDE
(-)-17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride
Naloxone hydrochloride occurs as a white to slightly off-white powder,
and is soluble in water, in
dilute acids, and in strong alkali; slightly soluble in alcohol;
practically insoluble in ether and in
chloroform.
Naloxone Hydrochloride Injection is available as a sterile solution
for intravenous, intramuscular and
subcutaneous administration in 1 mg/mL concentration. pH is adjusted
to 3.5 ± 0.5 with hydrochloric
acid. Each mL also contains 8.35 mg of sodium chloride. Naloxone
Hydrochloride Injection is
preservative-free.
CLINICAL PHARMACOLOGY
COMPLETE OR PARTIAL REVERSAL OF OPIOID DEPRESSION
Naloxone hydrochloride prevents or reverses the effects of opioids
including respiratory depression,
sedation, and hypotension. Also, it can reverse the psychotomimetic
and dysphoric effects of agonist-
antagonist 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. When administered
in usual doses and in the absence of opioids or agonistic effects of
other opioid antagonists, it exhibits
essentially no pharmacologic activity.
Naloxone hydrochloride has not been shown to produce tolerance or
cause physical or psychological
dependence. In the presence of physical dependence on opioids,
naloxone hydrochloride will produce
withdrawal symptoms. However, in the presence of opioid dependence,
opiate withdrawal symptoms
may appear within minutes of naloxone hydrochloride administration and
subside in about 2 hours. The
severity and d