NALOXONE HYDROCHLORIDE injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Naloxone Hydrochloride (UNII: F850569PQR) (Naloxone - UNII:36B82AMQ7N)

Tilgjengelig fra:

Dr. Reddy’s Laboratories, Inc.

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for diagnosis of suspected or known acute opioid overdosage. Naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock ). Naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in naloxone hydrochloride. Naloxone hydrochloride is an opioid antagonist. Physical dependence associated with the use of naloxone hydrochloride has not been reported. Tolerance to the opioid antagonist effect of naloxone hydrochloride is not known to occur

Produkt oppsummering:

Naloxone hydrochloride injection USP, for intravenous, intramuscular, and subcutaneous administration is available as: 1 mg/mL Each carton contains one 2 mg/2 mL Single-Dose Luer-Lock Prefilled Syringe and a 21 G x 1 ½” safety needle. NDC 43598-750-11 (contains no preservative) Ten cartons containing 2 mL Single-Dose Prefilled Syringe are packaged in an outer shipping box. NDC 43598-750-58 (contains no preservative). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Store in carton until contents have been used. Distributor: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540   Made in India

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION
DR. REDDY’S LABORATORIES, INC.
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Naloxone Hydrochloride Injection, USP
_OPIOID ANTAGONIST_
Rx Only
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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 dihydrate occurs as a white to almost white
powder, and is freely soluble in
water, soluble in ethanol (96%); practically insoluble in toluene.
Naloxone hydrochloride injection, USP 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 9 mg of sodium chloride. Naloxone hydrochloride
injection, USP 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, naloxone hydrochloride can reverse
the psychotomimetic 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. 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