Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride USP per tablet.
The tablets contain the following inactive ingredients: hypromellose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, talc, and titanium dioxide. Additionally, the 5 mg, 10 mg, and 30 mg tablets contain iron oxide red. The 7.5 mg and 10 mg tablets contain iron oxide black. The 10 mg tablets contain iron oxide yellow. The 20 mg tablets contain FD&C Blue No. 1/Brilliant Blue FCF Aluminum Lake. The 40 mg tablets contain D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6/Sunset Yellow FCF Aluminum Lake.
The chemical name of oxymorphone hydrochloride is 4,5α-epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white or slightly off-white, odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The pKa1 and pKa2 of oxymorphone at 37°C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37°C and pH 7.4 is 0.98.
The structural formula for oxymorphone hydrochloride is as follows: