NALOXONE HYDROCHLORIDE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Hospira, Inc.

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

Naloxone Hydrochloride Injection, USP is supplied in the following: NDC 0409-1215-01 Carton of 10 - Single-dose Fliptop Vials 0.4 mg/1 mL (0.4 mg/mL) NDC 0409-1219-01 Case of 25 Cartons (Each Carton includes 1 Multiple-dose Fliptop Vial) 4 mg/10 mL (0.4 mg/mL) Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from light. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1216-6.0 Revised: 07/2023

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
REFERENCE LABEL SET ID: BE337CB8-4026-45D2-A0BD-0801E5488A8E
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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:
19
21
4
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 propertie