País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
NALMEFENE HYDROCHLORIDE (UNII: K7K69QC05X) (NALMEFENE - UNII:TOV02TDP9I)
Purdue Pharma L.P.
INTRAMUSCULAR
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 presentation: A single-dose vial containing 2 mg/2 mL (1 mg/mL) of nalmefene base. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in original carton. Protect from light. Discard unused portion. For additional information, contact Purdue Pharma's Medical Services Department @ 1-888-726-7535.
Abbreviated New Drug Application
NALMEFENE HYDROCHLORIDE- NALMEFENE HYDROCHLORIDE INJECTION, SOLUTION PURDUE PHARMA L.P. ---------- 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 Molecular Weight: 375.9, CAS # 58895-64-0 Chemical Name: 17-(Cyclopropylmethyl)-4,5_a_-epoxy-6-methylenemorphinan-3,14-diol, hydrochloride salt. Nalmefene hydrochloride is a white to off-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 concentration of 1 mg of nalmefene free base per mL. The 1 mg/mL concentration contains 1.108 mg of nalmefene hydrochloride per mL, 9.0 mg of sodium chloride per mL, and the pH is adjusted to 3.9 with hydrochloric acid. Concentration and dosage 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 respiratory depression, sedation, and hypotension. Pharmacodynamic studies have shown that Nalmefene hydrochloride injection has a longer duration of action than 21 25 3 a 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 to produce tolerance, physical dependence, or abuse potential. Nalmefene hydrochloride injection can produce acute withdrawal symptoms in individuals who are opioid dependent. PHARMACOKINETICS Nalmef Leer el documento completo