NALOXONE HYDROCHLORIDE- naloxone hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Naloxone Hydrochloride (UNII: F850569PQR) (Naloxone - UNII:36B82AMQ7N)

Available from:

Cardinal Health

INN (International Name):

Naloxone Hydrochloride

Composition:

Naloxone Hydrochloride 1 mg in 1 mL

Administration route:

PARENTERAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naloxone hydrochloride injection is indicated for the complete or partial reversal of narcotic depression, including respiratory depression, induced by opioids including natural and synthetic narcotics, propoxyphene, methadone and certain narcotic-antagonist analgesics: nalbuphine, pentazocine and butorphanol. Naloxone hydrochloride is also indicated for the diagnosis of suspected acute opioid overdosage. Naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock. Naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to it.

Product summary:

1 mg/mL naloxone hydrochloride injection USP, for intravenous, intramuscular and subcutaneous administration. Available as follows: 1 mg/mL 2 mL single dose disposable prefilled syringes, in the MIN-I-JET® system with 21 G. x 11/2” needle. Boxes of 25.  NDC 76329-1469-5             Stock No. 1469 (contains no preservative) 2 mL single dose disposable Luer-JetTM Luer-Lock Prefilled Syringe. Shrink Wrapped Packages of 10. NDC 76329-3369-1             Stock No. 3369 (contains no preservative) The MIN-I-JET® syringe with needle, illustrated below, is the basic unit upon which all the other syringe systems are built; slight adaptations and/ or additional auxiliary parts create the other syringe systems. Assembly directions remain essentially the same. USE ASEPTIC TECHNIQUE Do not assemble until ready to use. Remove protective caps. Align vial such that the injector needle is centered on the stopper. Thread vial into injector 3 half turns, or until needle penetrates stopper. * DO NOT PUSH VIAL INTO INJECTOR; THIS MAY CAUSE MISALIGNMENT. Remove needle cap and expel air before injection. Protect from light. Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP]. Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION
CARDINAL HEALTH
----------
NALOXONE HYDROCHLORIDE
INJECTION, USP
NARCOTIC ANTAGONIST
Rx Only
DESCRIPTION
Naloxone hydrochloride, a narcotic 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.
17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride
C
H NO · HCl
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 non-preserved
sterile solution for intravenous,
intramuscular or subcutaneous administration in 1 mg/mL concentration.
Each mL of the 1 mg strength
contains 8.35 mg of sodium chloride. The pH is adjusted with
hydrochloric acid to meet USP limits of
3.0 to 4.5.
CLINICAL PHARMACOLOGY
Naloxone hydrochloride prevents or reverses the effects of opioids,
including respiratory depression,
sedation, and hypotension. Also, it can reverse the psychotomimetic
and dysphoric effects of agonist-
antagonist such as pentazocine.
Naloxone hydrochloride is an essentially pure narcotic antagonist,
i.e., it does not possess the
"agonistic" or morphine-like properties characteristic of other
narcotic antagonists; naloxone does not
produce respiratory depression, psychotomimetic effects or pupillary
constriction. In the absence of
narcotics or agonistic effects of other narcotic antagonists it
exhibits essentially no pharmacologic
activity.
Naloxone has not been shown to produce tolerance nor to cause physical
or psychological dependence.
In the presence of physical dependence on narcotics naloxone will
produce withdrawal symptoms.
MECHANISMS OF ACTION
While the mechanism of action of naloxone is not fully understood, the
preponderance of evidence
suggests that naloxone antagonizes the opioid effects by competing for
the same receptor si