"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
OPANA ER contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see WARNINGS AND PRECAUTIONS]. Assess each patient's risk for opioid abuse or addiction prior to prescribing OPANA ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OPANA ER for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence].
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of OPANA ER, even when the drug has been used as recommended and not misused or abused [see WARNINGS AND PRECAUTIONS]. Proper dosing and titration are essential and OPANA ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OPANA ER or following a dose increase. Instruct patients to swallow OPANA ER tablets whole. Crushing, dissolving, or chewing OPANA ER can cause rapid release and absorption of a potentially fatal dose of oxymorphone.
Accidental ingestion of OPANA ER, especially in children, can result in a fatal overdose of oxymorphone [see WARNINGS AND PRECAUTIONS].
Interaction with Alcohol
The co-ingestion of alcohol with OPANA ER may result in an increase of plasma levels and potentially fatal overdose of oxymorphone [see WARNINGS AND PRECAUTIONS]. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on OPANA ER.
OPANA ER tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. OPANA ER 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 per tablet.
The tablets contain the following inactive ingredients: hypromellose, methylparaben, silicified microcrystalline cellulose, sodium stearyl fumarate, TIMERx®-N, titanium dioxide, and triacetin. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets also contain macrogol, and polysorbate 80.
In addition, the 5 mg, 7.5 mg and 30 mg tablets contain iron oxide red. The 7.5 mg tablets contain iron oxide black, and iron oxide yellow. The 10 mg tablets contain FD&C yellow No. 6. The 20 mg tablets contain FD&C blue No. 1, FD&C yellow No. 6, and D&C yellow No. 10. The 40 mg tablets contain FD&C yellow No. 6, D&C yellow No. 10, and lactose monohydrate.
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 molecular weight of oxymorphone hydrochloride is 337.80. 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:
What are the possible side effects of oxymorphone (Opana, Opana ER)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- seizure (convulsions);
- cold, clammy skin;
- severe weakness or dizziness; or
- feeling light-headed, fainting.
Less serious side effects are more likely to occur, such as:
- nausea, vomiting, constipation;
What are the precautions when taking oxymorphone hydrochloride extended release (Opana ER)?
Before taking oxymorphone, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., codeine, morphine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercarbia, severe asthma), certain bowel diseases (e.g., paralytic ileus, infectious diarrhea), moderate/severe liver disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders...
Last reviewed on RxList: 7/27/2012
This monograph has been modified to include the generic and brand name in many instances.
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