OPANA (oxymorphone hydrochloride) tablet is an opioid agonist available in 40mg tablet strengths for oral administration. The chemical name for oxymorphone hydrochloride is 4, 5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 337.80. The molecular formula is C17H19NO4. HCl and it has the following chemical structure.
OPANA (oxymorphone hydrochloride) Structural Formula Illustration
Oxymorphone hydrochloride is white to off white odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water
The inactive ingredients in OPANA include: lactose monohydrate, magnesium stearate, and pregelatinized starch. In addition, the 40 mg tablets contain FD&C blue No. 2 aluminum lake. The 10 mg tablets contain D&C red No. 30 aluminum lake.
OPANA is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Dosage Forms And Strengths
Tablets 40 mg: red, round, convex tablet debossed with E613 over 40 on one side and plain on the other.
Storage And Handling
OPANA (oxymorphone hydrochloride) tablets are supplied as follows:
40 mg Tablet
Red, round, convex tablets debossed with E613 over 40 on one side and plain on the other.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
Dispense in tight container as defined in the USP, with a child-resistant closure (as required).
Limitations Of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS], reserve OPANA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
-Have not been tolerated, or are not expected to be tolerated,
-Have not provided adequate analgesia, or are not expected to provide adequate analgesia