Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)
General Injectables & Vaccines, Inc.
NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE 1 mg in 1 mL
PARENTERAL
PRESCRIPTION DRUG
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 and butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the 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 it or to any of the other ingredients in naloxone hydrochloride. Naloxone hydrochloride is an opioid antagonist. Physical dependence associated with the use of naloxone hydrochloride has not been reported. Tolerance to the opioid antagonist effect of naloxone hydrochloride is not known to occur.
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. Shrink Wrapped Packages of 10. NDC 76329-1469-1 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) 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 create the other syringe systems. Assembly directions remain essentially the same. USE ASEPTIC TECHNIQUE Do not assemble until ready to use.
Abbreviated New Drug Application
NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION GENERAL INJECTABLES & VACCINES, INC. ---------- NALOXONE HYDROCHLORIDE INJECTION, USP OPIOID ANTAGONIST RX ONLY DESCRIPTION NALOXONE HYDROCHLORIDE INJECTION, USP Opioid Antagonist Rx Only Naloxone hydrochloride, 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 (-)-17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride 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 sterile solution for intravenous, intramuscular and subcutaneous administration in 1 mg/mL concentration. pH is adjusted to 3.5 ± 0.5 with hydrochloric acid. Each mL also contains 8.35 mg of sodium chloride. Naloxone Hydrochloride Injection is preservative-free. CLINICAL PHARMACOLOGY Complete or Partial Reversal of Opioid Depression 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 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 activity. Naloxone hydrochloride has not been shown to produce tolerance or cause physical or psychological dependence. In the presence of physical dependence on opioids, naloxone hydrochloride will produce withdrawal symptoms. However, in the presence of opioid dependence, opiate withdrawal symptoms may appear within minutes of nalo Les hele dokumentet