Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
NALTREXONE HYDROCHLORIDE (UNII: Z6375YW9SF) (NALTREXONE - UNII:5S6W795CQM)
NuCare Pharmaceuticals, Inc.
NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE 50 mg
ORAL
PRESCRIPTION DRUG
Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions. Naltrexone is contraindicated in: - Patients receiving opioid analgesics. - Patients currently dependent on opioids, including those currently maintained on opiate agonists [e.g., methadone or LAAM (levo- alpha-acetyl-methadol)]. - Patients in acute opioid withdrawal (see WARNINGS ). - Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids. - Any individual with a history of sensitivity to naltrexone or any other components of this product. It is not known if there is any cross-sensitivity with naloxone or the phenanthrene containing opioids. - Any individual with acute hepatitis or liver failure. Naltrexone is a pure opioid antagonist. It does not lead
Naltrexone Hydrochloride Tablets, USP 50 mg are yellow, round film-coated tablets, bisected on one side, debossed with "EL" on one side of the bisect and "15" on the other side of the bisect. They are available in bottles of: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light.
Abbreviated New Drug Application
NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED NUCARE PHARMACEUTICLS, INC. ---------- NALTREXONE HYDROCHLORIDE TABLETS USP, FILM COATED RX ONLY DESCRIPTION Naltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone hydrochloride differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. The chemical name for naltrexone hydrochloride is Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, hydrochloride, (5a)-. The structural formula is as follows: C H NO ·HCl Molecular Weight: 377.87 Naltrexone hydrochloride is a white, crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL. Each film-coated tablet, for oral administration, contains 50 mg of naltrexone hydrochloride. In addition each film-coated tablet contains the following inactive ingredients: carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and yellow iron oxide. CLINICAL PHARMACOLOGY PHARMACODYNAMIC ACTIONS Naltrexone hydrochloride is a pure opioid antagonist. It markedly attenuates or completely blocks, reversibly, the subjective effects of intravenously administered opioids. When co-administered with morphine, on a chronic basis, naltrexone blocks the physical dependence to morphine, heroin and other opioids. Naltrexone has few, if any, intrinsic actions besides its opioid blocking properties. However, it does produce some pupillary constriction, by an unknown mechanism. 20 23 4 The administration of naltrexone is not associated with the development of tolerance or dependence. In subjects physically dependent on opioids, naltrexone will precipitate withdrawal symptoma Прочетете целия документ