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:

Somerset Therapeutics, LLC

INN (International Name):

NALOXONE HYDROCHLORIDE

Composition:

NALOXONE HYDROCHLORIDE 0.4 mg in 1 mL

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, 4 mg/10 mL (0.4 mg/mL) is a clear, colorless solution. Naloxone Hydrochloride Injection USP, 4 mg/10 mL (0.4 mg/mL) for intravenous, intramuscular, and subcutaneous administration is available as:  NDC 70069-072 -01   - 10 mL vials are Multiple-Dose Vials, packaged as monocarton. NDC 70069-072 -10   - 10 monocartons are packaged in an Inner Carton. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from light. Store in the carton until contents have been used. Discard unused portion. For Product Inquiry call 1-800-417-9175. ST-NLX12/P/04 Revised: February, 2020 Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024   Made in India Code No.: KR/DRUGS/KTK/28/289/97

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
SOMERSET THERAPEUTICS, LLC
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NALOXONE HYDROCHLORIDE INJECTION, USP
USP TYPE-I CLEAR TUBULAR GLASS VIAL, OPIOID ANTAGONIST
PROTECT FROM LIGHT BY RETAINING IN THE CARTON UNTIL READY FOR USE.
DISCARD UNUSED PORTION.
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 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
19
21
4
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 agonistic
effects of other
opioid antagonists, it exhibits essentially no pharmacologic