NALOXONE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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.

Product summary:

Naloxone Hydrochloride Injection, USP is supplied in the following: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-1217-5.0 Revised: 9/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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NALOXONE HYDROCHLORIDE
Injection, USP
FLIPTOP VIAL, OPIOID ANTAGONIST
PROTECT FROM LIGHT.
RX ONLY
DESCRIPTION
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
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-
dihydroxymorphinan-6-one hydrochloride (C
H NO • HCl), a white to slightly off-white powder
soluble in water, in dilute acids, and in strong alkali; slightly
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.
19
21
4
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
administe