NALOXONE HYDROCHLORIDE injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

McKesson Corporation

INN (Nama Antarabangsa):

Naloxone Hydrochloride

Komposisi:

Naloxone Hydrochloride 0.4 mg in 1 mL

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

Product: 63739-463 NDC: 63739-463-21 1 mL in a AMPULE / 1 in a POUCH / 5 in a BOX

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION
MCKESSON CORPORATION
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NALOXONE HYDROCHLORIDE
Injection, USP
AMPUL, FLIPTOP VIAL, OPIOID ANTAGONIST
PROTECT FROM LIGHT.
R 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 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.
x
19
21
4
Naloxone is an essentially pure opioid antagonist, i.e., it does not
possess the "agonistic" or morphine-
like properties characteristic of other opioid antagonists.