NALOXONE HYDROCHLORIDE injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Hospira, Inc.

INN (Kansainvälinen yleisnimi):

NALOXONE HYDROCHLORIDE

Koostumus:

NALOXONE HYDROCHLORIDE 0.4 mg in 1 mL

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 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 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 kno

Tuoteyhteenveto:

Naloxone hydrochloride injection, USP for intravenous, intramuscular, and subcutaneous administration is available as: NDC 0409-1782-69 Box of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 0.4 mg/mL Instructions for Use of the Syringe Systems Needle not included . Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02. Protect from light. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                    LAB-1215-3.0 Revised: 03/2023

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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NALOXONE HYDROCHLORIDE
INJECTION, USP
_Opioid Antagonist_
Rx Only
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. It is known chemically as
17-allyl-4,5α-epoxy,3-14-
dihydroxymorphinan-6-one hydrochloride. It has a molecular weight of
363.84, and the
following structural formula:
Naloxone hydrochloride occurs as a white to slightly off-white powder,
and is soluble in
water, in dilute acids, and in strong alkali; slightly soluble in
alcohol; practically insoluble in
ether and in chloroform.
Naloxone hydrochloride injection is available as a sterile solution
for intravenous,
intramuscular, and subcutaneous administration. Each mL contains 0.4
mg of naloxone
hydrochloride. Each mL contains 8.9 mg of sodium chloride. The pH is
adjusted between
3.0 to 6.5 with hydrochloric acid or sodium hydroxide. The air in the
cartridges has been
displaced by nitrogen gas.
CLINICAL PHARMACOLOGY
Naloxone prevents or reverses the effects of opioids including
respiratory depression,
sedation and hypotension. Also, it 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 in the absence of opioids or agonistic
effects of other opioid
antagonists, it exhibits essentially no pharmacologic activity.
Naloxone has not been shown to produce tolerance or cause physical or
psychological
dependence. In the presence of physical dependence on opioids,
naloxone will produce
withdrawal symptoms. However, in the presence of opioid dependence,
withdrawal
symptoms will appear within minutes of naloxone administration and
will subside in
about 2 hours. The sev