NALOXONE HYDROCHLORIDE injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

General Injectables and Vaccines, Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Naloxone Hydrochloride Injection, USP is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural or synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone 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 contained in the formulation. Naloxone hydrochloride injection is an opioid antagonist. Physical dependence associated with the use of naloxone hydrochloride injection has not been reported. Tolerance to the opioid antagonist effect of naloxone is not known to occur.

Resumen del producto:

Naloxone Hydrochloride Injection, USP (Preservative Free ) is supplied in a single dose vial as follows: NDC 17478-041-01                           10 Single-dose vials (1 mL each) Naloxone Hydrochloride Injection, USP (Preserved ) is supplied in a multiple dose vial as follows: NDC 17478-042-10                           10 mL Multi-dose vial, 4 mg/10 mL (0.4 mg/mL)

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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NALOXONE HYDROCHLORIDE
DESCRIPTION
RX ONLY
Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic
solution of naloxone hydrochloride
in water for injection. Each milliliter (mL) contains 0.4 mg naloxone
hydrochloride and sodium chloride
8.9 mg to adjust tonicity in water for injection. May contain
hydrochloric acid for pH adjustment; pH 4.0
(3.0 to 6.5).
The single-dose solution contains no bacteriostat, antimicrobial agent
or added buffer (except for pH
adjustment) and is intended for use only as a single-dose injection.
When smaller doses are required, the
unused portion should be discarded.
The multiple-dose solution contains, in addition, 1.8 mg/mL
methylparaben and 0.2 mg/mL
propylparaben added as preservatives.
Naloxone Hydrochloride Injection, USP may be administered
intravenously, intramuscularly, or
subcutaneously.
Naloxone, an opioid antagonist, is a synthetic congener of
oxymorphone. It differs from oxymorphone
in that the methyl group on the nitrogen atom is replaced by an allyl
group.
Naloxone Hydrochloride, USP is chemically designated
17-Allyl-4,5α-epoxy-3,14-
dihyroxymorphinan-6-one hydrochloride (C
H NO •HCI), a white to slightly off-white powder
soluble in water, in dilute acids, and in strong alkali; slight
soluble in alcohol; practically insoluble in
ether and chloroform. It has a molecular weight of 363.84. It has the
following structural formula:
CLINICAL PHARMACOLOGY
COMPLETE OR PARTIAL REVERSAL OF OPIOID DEPRESSION
Naloxone prevents or reverses the effects of opioids including
respiratory depression, sedation and
hypotension. Also, naloxone can reverse the psychotomimetic and
dysphoric effects of agonist-
antagonists, such as pentazocine.
Naloxone 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 op