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:

Mylan Institutional LLC

INN (International Name):

NALOXONE HYDROCHLORIDE

Composition:

NALOXONE HYDROCHLORIDE 0.4 mg in 1 mL

Administration route:

INTRAVENOUS

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 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 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 no

Product summary:

Naloxone Hydrochloride Injection, USP is supplied in the following: NDC 67457-299-10 carton containing ten multiple-dose vials, 4 mg/10 mL (0.4 mg/mL) 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. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 1017L102 Revised: 4/2021 MI:NALOIJM:R3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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DESCRIPTION
Naloxone, 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 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:
Naloxone hydrochloride injection 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 (3 to 6.5).
Naloxone hydrochloride injection may be administered intravenously,
intramuscularly, or
subcutaneously.
The multiple-dose solution contains, in addition, 1.8 mg/mL
methylparaben and 0.2
mg/mL propylparaben added as preservatives.
CLINICAL PHARMACOLOGY
When naloxone hydrochloride is administered intravenously, the onset
of action is
generally apparent within 2 minutes. The onset of action is slightly
less rapid when it is
administered subcutaneously or intramuscularly. The duration of action
is dependent
upon the dose and route of administration of naloxone hydrochloride.
Intramuscular
administration produces a more prolonged effect than intravenous
administration. Since
the duration of action of naloxone may be shorter than that of some
opiates, the effects
of the opiate may return as the effect of naloxone dissipates. The
requirement for
repeat doses of naloxone, however, will also be dependent upon the
amount, type and
route of administration of the opioid being antagonized.
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21
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COMPLETE OR PARTIAL REVERSAL OF OPIOID DEPRESSION