NALOXONE HYDROCHLORIDE- naloxone hydrochloride injection

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Physicians Total Care, Inc.

INN (Isem Internazzjonali):

Naloxone Hydrochloride

Kompożizzjoni:

Naloxone Hydrochloride 1 mg in 1 mL

Rotta amministrattiva:

PARENTERAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

Available as follows: 1 mg/mL 2 mL single dose disposable Luer-Jet™ Luer-Lock Prefilled Syringe.                 Shrink Wrapped Packages of 20        NDC 54868-6259-0 (contains no preservative) Syringe Assembly Directions 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 createthe other syringe systems. Assembly directions remain essentially the same. USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Protect from light. Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP]. Rx Only INTERNATIONAL MEDICATION SYSTEMS, LIMITED SO. EL MONTE, CA 91733, U.S.A An Amphastar Pharmaceuticals Company 6914660M REV. 8-01 Relabeling of "Additional" label by: Physicians Total Care, Inc. Tulsa, OK      74146

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

NALOXONE HYDROCHLORIDE - NALOXONE HYDROCHLORIDE INJECTION
PHYSICIANS TOTAL CARE, INC.
----------
NALOXONE HYDROCHLORIDE 1MG/1ML 2ML SYRINGE
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-4,5a-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride
C19H21NO4• HCl 363.84
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 the 0.4 mg/mL and 1
mg/mL concentrations. Each mL of
the 0.4 mg strength contains 8.6 mg of sodium chloride. 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
sugge