Oxymorphone

Oxymorphone is used to manage pain severe enough to require an opioid pain medicine when other pain medicines do not treat pain well enough, or are not tolerated. It is a strong prescription oral pain medicine that contains an opioid (narcotic)

Oxymorphone tablets are used to manage short-term (acute) pain. Oxymorphone extended-release tablets are used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine.

Oxymorphone can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics to balance benefits against risks of addiction and misuse. Prescribers must complete REMS-compliant education, counsel patients on safe use and disposal, ensure patients read Medication Guides, and consider patient-prescriber agreements to enhance safety.

Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. It provides analgesia with no ceiling effect, meaning doses are limited only by adverse effects like respiratory and CNS depression. Its precise analgesic mechanism is unknown, but CNS opioid receptors throughout the brain and spinal cord are believed to be involved.

Oxymorphone first gained FDA approval on April 2, 1959 and is a Schedule II controlled substance.

Oxymorphone is only available as a generic as the brand names Opana, Opana ER and Numorphan have been discontinued.

Get emergency help or call 911 right away if you take too much oxymorphone (overdose). When you first start taking oxymorphone, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.

Taking oxymorphone with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Never give anyone else your oxymorphone. They could die from taking it. Selling or giving away oxymorphone is against the law.

Store oxymorphone securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take oxymorphone if you have:

• Severe asthma
• Trouble breathing or other lung problems
• A bowel blockage or a narrowing of the stomach or intestines
• An allergy to oxymorphone or any of the ingredients in your oxymorphone preparations
• Moderate or severe liver problems.

Before taking oxymorphone, tell your healthcare provider if you have a history of:

• Head injury, seizures
• Liver, kidney, thyroid problems
• Problems urinating
• Pancreas or gallbladder problems
• Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

• Noticing your pain is getting worse. If your pain gets worse after you take oxymorphone, do not take more of oxymorphone without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking oxymorphone.
• Pregnant or planning to become pregnant. Using oxymorphone for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• Breastfeeding. Oxymorphone passes into breast milk and may harm your baby. Breastfeeding is not recommended during treatment with extended-release tablets. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
• Living in a household where there are small children or someone who has abused street or prescription drugs.
• Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxymorphone with certain other medicines can cause serious side effects that could lead to death.

Common Side Effects

The possible side effects of oxymorphone are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain.

Call your healthcare provider if you have any of these symptoms and they are severe.

Serious Side Effects

Get emergency medical help or call 911 right away if you have:

• Trouble breathing
• Shortness of breath
• Fast heartbeat
• Chest pain
• Swelling of your face, tongue, throat, or hands, hives, itching, or rash
• Extreme drowsiness
• Light-headedness when changing positions
• Feeling faint
• Agitation
• High body temperature
• Trouble walking
• Stiff muscles
• Mental changes such as confusion.

These are not all the possible side effects of oxymorphone. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

When taking oxymorphone, do not change your dose. Take oxymorphone exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

Oxymorphone Tablets (Immediate-Release)

• For acute (short-term) pain, you may only need to take oxymorphone tablets for a few days.
• Take your prescribed dose every 4 to 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Oxymorphone tablets should be taken on an empty stomach, at least one hour prior to or two hours after eating.

You may have some oxymorphone left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused oxymorphone.

Oxymorphone Extended-Release Tablets

• Your healthcare prescriber will prescribe the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals
• Take your prescribed dose twice daily (every 12 hours) at the same time every day.
• Swallow oxymorphone extended-release tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject oxymorphone extended-release tablets because this may cause you to overdose and die.
• Oxymorphone extended-release tablets should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing it in your mouth to avoid choking on the tablet.
• Administer on an empty stomach at least 1 hour before food or 2 hours after food.
• Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.

Comments

• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking oxymorphone regularly, do not stop taking oxymorphone without talking to your healthcare provider.

How do I Dispose of Oxymorphone?

Dispose of expired, unwanted, or unused oxymorphone by promptly flushing it down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking oxymorphone, DO NOT:

• Drive or operate heavy machinery until you know how oxymorphone affects you. oxymorphone can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with oxymorphone may cause you to overdose and die.

Oxymorphone can interact dangerously with many medications, potentially causing serious side effects or death. Always inform your doctor of all medications you take, including:

• Other opioids, pain medicines, or prescription cough medicines
• Sedatives, such as Xanax, Valium, Ativan, Klonopin, or Restoril
• Sleeping pills, muscle relaxants, or tranquilizers
• Mental health medications for depression, anxiety, or other conditions
• Neurological medications for Parkinson's disease, migraines, or seizures
• Antibiotics, antifungals, or HIV/hepatitis C treatments
• Heart or blood pressure medications
• Cold, allergy, or asthma medications
• Nausea, motion sickness, or bladder medications

Some medications affect how oxymorphone is processed in the body, potentially raising levels to dangerous concentrations. This list is not complete; always check with your doctor or pharmacist before starting or stopping any medication, including over-the-counter products, vitamins, and herbal supplements.

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