देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)
Somerset Therapeutics, LLC
NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE 0.4 mg in 1 mL
INTRAMUSCULAR
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, 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
Naloxone Hydrochloride Injection USP, 4 mg/10 mL (0.4 mg/mL) is a clear, colorless solution. Naloxone Hydrochloride Injection USP, 4 mg/10 mL (0.4 mg/mL) for intravenous, intramuscular, and subcutaneous administration is available as: NDC 70069-072 -01 - 10 mL vials are Multiple-Dose Vials, packaged as monocarton. NDC 70069-072 -10 - 10 monocartons are packaged in an Inner Carton. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from light. Store in the carton until contents have been used. Discard unused portion. For Product Inquiry call 1-800-417-9175. ST-NLX12/P/04 Revised: February, 2020 Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97
Abbreviated New Drug Application
NALOXONE HYDROCHLORIDE- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION SOMERSET THERAPEUTICS, LLC ---------- NALOXONE HYDROCHLORIDE INJECTION, USP USP TYPE-I CLEAR TUBULAR GLASS VIAL, OPIOID ANTAGONIST PROTECT FROM LIGHT BY RETAINING IN THE CARTON UNTIL READY FOR USE. DISCARD UNUSED PORTION. RX 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 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 19 21 4 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. Naloxone 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 पूरा दस्तावेज़ पढ़ें