देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
NALMEFENE HYDROCHLORIDE (UNII: K7K69QC05X) (NALMEFENE - UNII:TOV02TDP9I)
Chengdu Shuode Pharmaceutical Co., Ltd
INTRAVENOUS
PRESCRIPTION DRUG
Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose. Nalmefene Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to the product. Nalmefene hydrochloride injection is an opioid antagonist with no agonist activity. It has no demonstrated abuse potential, is not addictive, and is not a controlled substance.
Nalmefene Hydrochloride Injection is available in the following presentations: A single-dose vial containing 1 mL of 100 µg/mL nalmefene base (Blue Label) Box of 1 (NDC 82432-101-01) A single-dose vial containing 2 mL of 1 mg/mL nalmefene base (Green Label) Box of 1 (NDC 82432-102-02) Protect from light, store at 20°C-25°C (68°F to 77°F). [see USP Controlled Room Temperature] Discard unused portion. Manufacturer Chengdu Shuode Pharmaceutical Co., Ltd No. 9 Lekang Road, Shuangliu District Chengdu, Sichuan 610200 China (CHN) Revision date: 06/27/2023
Abbreviated New Drug Application
NALMEFENE HYDROCHLORIDE- NALMEFENE HYDROCHLORIDE INJECTION SOLUTION CHENGDU SHUODE PHARMACEUTICAL CO., LTD ---------- NALMEFENE HYDROCHLORIDE INJECTION RX ONLY DESCRIPTION Nalmefene Hydrochloride Injection, an opioid antagonist, is a 6-methylene analogue of naltrexone. The chemical structure is shown below: Molecular Formula: C H NO •HCl•H O Molecular Weight: 393.91, CAS # 1228646-72-7 Chemical Name: 17-(Cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol, hydrochloride salt, monohydrate Nalmefene hydrochloride is a white to almost white crystalline powder which is freely soluble in water up to 130 mg/mL and slightly soluble in chloroform up to 0.13 mg/mL, with a pK of 7.6. Nalmefene Hydrochloride Injection is available as a sterile solution for intravenous, intramuscular, and subcutaneous administration in two concentrations, containing 100 µg or 1.0 mg of nalmefene free base per mL. The 100 µg/mL concentration contains 110.8 µg of nalmefene hydrochloride and the 1.0 mg/mL concentration contains 1.108 mg of nalmefene hydrochloride per mL. Both concentrations contain 9.0 mg of sodium chloride per mL and the pH is adjusted in the range of 3.3-3.5 with hydrochloric acid. Concentrations and dosages of Nalmefene Hydrochloride Injection are expressed as the free base equivalent of nalmefene. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Nalmefene hydrochloride injection prevents or reverses the effects of opioids, including 21 25 3 2 a respiratory depression, sedation, and hypotension. Pharmacodynamic studies have shown that nalmefene hydrochloride injection has a longer duration of action than naloxone at fully reversing doses. Nalmefene hydrochloride injection has no opioid agonist activity. Nalmefene hydrochloride injection is not known to produce respiratory depression, psychotomimetic effects, or pupillary constriction. No pharmacological activity was observed when nalmefene hydrochloride injection was administered in the absence of opioid agonists. Nalmefene hydrochloride injection has not been shown t पूरा दस्तावेज़ पढ़ें