NALOXONE HYDROCHLORIDE injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Akorn

INN (Mezinárodní Name):

Naloxone Hydrochloride

Složení:

Naloxone Hydrochloride 0.4 mg in 1 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Naloxone Hydrochloride Injection, USP 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.

Přehled produktů:

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) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until contents are used. AKORN Manufactured for: Akorn, Inc. Lake Forest, IL 60045 NL00N          Rev. 07/19

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
AKORN
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NALOXONE HYDROCHLORIDE INJECTION, USP
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 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-
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.
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 opioids or agonis