NALOXONE HYDROCHLORIDE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Medical Purchasing Solutions, LLC

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 injection is also indicated for 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 to any of the other ingredients contained in the formulation. Naloxone hydrochloride is an opioid antagonist. Physical dependence associated with the use of naloxone hydrochloride has not been reported. Tolerance to the opioid antagonist effect of n

Produkt oppsummering:

Naloxone hydrochloride injection, USP is a sterile, clear colorless solution for intravenous, intramuscular, or subcutaneous administration and is available as: 4 mg per 10 mL (0.4 mg / mL) 10 mL Multiple Dose Vials in a Carton of 10                                                        NDC 55150-328-10 10 mL Multiple Dose Vials in a Carton of 25                                                        NDC 55150-328-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store in carton until contents have been used. The vial stopper is not made with natural rubber latex. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India Revised: August 2019

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
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NALOXONE HYDROCHLORIDE INJECTION, USP
_OPIOID ANTAGONIST_
RX ONLY
DESCRIPTION
Naloxone hydrochloride injection USP, 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.
Naloxone hydrochloride USP 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, USP is available as a sterile, clear
colorless solution for
intravenous, intramuscular or subcutaneous administration in the
concentration 0.4 mg
of naloxone hydrochloride per mL.
pH is adjusted to 3.0 to 6.5 with hydrochloric acid.
The 0.4 mg/mL vial contains 8.6 mg/mL of sodium chloride and 2 mg/mL
of
methylparaben and propylparaben as preservatives in a ratio of 9:1.
CLINICAL PHARMACOLOGY
COMPLETE OR PARTIAL REVERSAL OF OPIOID DEPRESSION
Naloxone hydrochloride prevents or reverses the effects of opioids
including respiratory
depression, sedation and hypotension. Also, naloxone hydrochloride can
reverse the
psychotomimetic and dysphoric effects of agonist-antagonists such as
pentazocine.
Naloxone hydrochloride 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
agonistic effects of
other opioid antagonists, it exhibits essentially no pharmacologic
activity.
Naloxone hydrochloride has not been shown to produce tolerance or
cause physical or
psychological dependence. In the presence of physical dependence on
opioids, naloxone
hydrochloride will produce withdrawal symptoms. However, in the
presence of opioid
dependence, opiate withdrawal symptoms may appear within minutes of
naloxone
hydrochlorid