Opana ER (Oxymorphone Hydrochloride Extended Release) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Opana ER

Pain Management »

Introduction to pain management

Pain management can be simple or complex, depending on the cause of the pain. An example of pain that is typically less complex would be nerve root irritation from a herniated disc with pain radiating down the leg. This condition can often be alleviated with an epidural steroid injection and physical therapy. Sometimes, however, the pain does not go away. This can require a wide variety of skills and techniques to treat the pain. These skills and techniques include:

Interventional procedures
Medication management
Physical therapy or chiropractic therapy
Psychological counseling and support
Acupuncture and other alternative therapies; and
Referral to other medical specialists

All of these skills and services are necessary because pain can involve many aspects of a person's daily life.

How is pain tre...

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OPANA® ER
(oxymorphone hydrochloride)

WARNING

POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE

Potential for Abuse

OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.

Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Proper Patient Selection

OPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

OPANA ER is NOT intended for use as an as needed analgesic.

OPANA ER tablets are to be swallowed whole and are not to be cut, broken, chewed, dissolved, or crushed. Taking cut, broken, chewed, dissolved, or crushed OPANA ER tablets leads to rapid release and absorption of a potentially fatal dose of oxymorphone.

Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

DRUG DESCRIPTION

OPANA ER (oxymorphone hydrochloride) extended-release tablet is a semi-synthetic opioid analgesic 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, polyethylene oxide, polyethylene glycol, α-tocopherol, citric acid, polyvinyl alcohol, titanium dioxide, macrogol and talc. 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, and D&C yellow No. 10.

Chemically, 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 very slightly soluble in 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:

OPANA® ER (oxymorphone hydrochloride) Structural Formula Illustration

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;
confusion;
severe weakness or dizziness; or
feeling light-headed, fainting.

Less serious side effects are more likely to occur, such...

Read All Potential Side Effects and See Pictures of Opana ER »

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), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives),...

Read All Potential Precautions of Opana ER »

Last reviewed on RxList: 12/28/2011
This monograph has been modified to include the generic and brand name in many instances.