Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
NALTREXONE HYDROCHLORIDE (UNII: Z6375YW9SF) (NALTREXONE - UNII:5S6W795CQM)
SpecGx LLC
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 hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions. Naltrexone is contraindicated in: 1. Patients receiving opioid analgesics. 2. Patients currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine). 3. Patients in acute opioid withdrawal (see WARNINGS ). 4. Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids. 5. 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. Naltrexone is a pure opioid antagonist. It does not lead to physical or psychological depend
Naltrexone Hydrochloride Tablets USP 50 mg are available as a yellow film coated capsule-shaped tablet with a convex surface, debossed with a number “50” and a full bisect in between the 5 and 0 on one side and “1170” on the other side. Bottles of 30……………NDC 0406-1170-03 Bottles of 100…………..NDC 0406-1170-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2022 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 07/2022 Mallinckrodt™ Pharmaceuticals
Abbreviated New Drug Application
NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED SPECGX LLC ---------- NALTREXONE HYDROCHLORIDE TABLETS USP 50 MG OPIOID ANTAGONIST RX ONLY DESCRIPTION Naltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone 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. naltrexone hydrochloride Naltrexone hydrochloride is a white, crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL. Naltrexone Hydrochloride Tablets USP are available as film coated tablets, containing 50 mg of naltrexone hydrochloride. Naltrexone hydrochloride tablets also contain: crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide, yellow iron oxide and red iron oxide. CLINICAL PHARMACOLOGY PHARMACODYNAMIC ACTIONS Naltrexone is a pure opioid antagonist. It markedly attenuates or completely blocks, reversibly, the subjective effects of intravenously administered opioids. When coadministered 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. The administration of naltrexone is not associated with the development of tolerance or dependence. In subjects physically dependent on opioids, naltrexone will precipitate withdrawal symptomatology. Clinical studies indicate that 50 mg of naltrexone hydrochloride will block the pharmacologic effects of 25 mg of intravenously administered heroin for periods as long as 24 hours. Other data suggest that doubling the dose of naltrexone hydrochl Prečítajte si celý dokument