Clinical Information
Gen. Code and Des.
4518 naltrexone HCl ORAL TABLET 50 MG
GCN and Des.
17070 naltrexone HCl ORAL TABLET 50 MG
Strength
50MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
28100000 OPIATE ANTAGONISTS
92040000 ALCOHOL DETERRENTS
Active Ingredients
1615 naltrexone HCl 16676292
Inactive Ingredients
2432 lactose 64044515
REVIA- naltrexone hydrochloride tablet, film coated
Rx only
DESCRIPTION
REVIA� (naltrexone hydrochloride tablets USP), 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. REVIA 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, (5?)-.
C20 H23 NO4 �HCl M.W. 377.86
REVIA is a white, crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL. REVIA is available in scored film-coated tablets containing 50 mg of naltrexone hydrochloride.
REVIA Tablets also contain: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, yellow iron oxide and titanium dioxide.
CLINICAL PHARMACOLOGY
Pharmacodynamic Actions
REVIA 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, REVIA blocks the physical dependence to morphine, heroin and other opioids.
REVIA 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 REVIA is not associated with the development of tolerance or dependence. In subjects physically dependent on opioids, REVIA will precipitate withdrawal symptomatology.
INDICATIONS AND USAGE
REVIA (naltrexone hydrochloride tablets, USP) is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.
REVIA has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
