Oxymorphone

Why is this medicine prescribed?

Oxymorphone is used to relieve severe pain. Oxymorphone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the body responds to pain.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Oxymorphone comes as an immediate-release tablet and as an extended-release (long-acting) tablet to take by mouth on an empty stomach, at least 1 hour before or 2 hours after meals. Take the immediate-release tablet every 4 to 6 hours as needed for pain. Take the extended-release tablets every 12 hours.

Swallow the extended-release tablets whole; do not break, chew, dissolve, or crush them.

Your doctor may adjust your dose of oxymorphone during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with oxymorphone. Do not take more of it or take it more often than prescribed by your doctor.

Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene,while taking oxymorphone. Rescue medications can reverse the life-threatening effects of anopioid overdose and are available over the counter or with a prescription. Make sure that youand your family members and people usually around you know how to recognize an overdose,how to use naloxone or nalmefene, and what to do until emergency medical help arrives. Yourdoctor or pharmacist will show you and others how to use it. If symptoms of an overdose occur,they should give the first dose of naloxone, call 911 immediately, and stay with you and watchyou closely until emergency medical help arrives. If your symptoms return, the person shouldgive you another dose of the rescue medication. Additional doses may be given every 2 to 3minutes, if symptoms return before medical help arrives.

Do not stop taking oxymorphone without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking oxymorphone, you may experience withdrawal symptoms such as restlessness; watery eyes; runny nose; yawning; sweating; chills; muscle, joint, or back pain; enlarged pupils (black circles in the centers of the eyes); irritability; anxiety; weakness; stomach cramps; difficulty falling asleep or staying asleep; nausea; vomiting; diarrhea; loss of appetite; fast heartbeat; and fast breathing.

What special precautions should I follow?

Before taking oxymorphone,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• some medications should not be taken with oxymorphone. Make sure you have discussed anymedications you are currently taking or plan to take before starting oxymorphone with your doctorand pharmacist. Before starting, stopping, or changing any medications while taking oxymorphone,please get the advice of your doctor or pharmacist.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, or tranylcypromine.

• the following nonprescription or herbal products may interact with oxymorphone: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking oxymorphone. Do not start these medications while taking oxymorphone without discussing it with your healthcare provider.

• tell your doctor if you have slowed breathing, asthma, chronic pulmonary disease (COPD), or other lung problems; liver disease; blockage in your stomach or intestine; or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take oxymorphone.

• tell your doctor if you have or have ever had a brain tumor, or any condition that increases the amount of pressure in your brain; seizures; or kidney, heart, pancreas, thyroid, or gall bladder disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If youbecome pregnant while taking oxymorphone, call your doctor.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking oxymorphone.

• you should know that oxymorphone may make you drowsy, dizzy, or lightheaded. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know to not drink alcoholic beverages while you are taking oxymorphone. Alcohol can make the side effects from oxymorphone worse.

• you should know that oxymorphone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that oxymorphone may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using oxymorphone.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

If you are taking oxymorphone on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take more than one dose of the extended-release tablets in 12 hours.

What side effects can this medicine cause?

Oxymorphone may cause side effects. Tell your doctor if any of these symptoms or those in the SPECIAL PRECAUATIONS section are severe or do not go away:

• dry mouth
• stomach pain
• nausea, vomiting
• decreased appetite
• excessive sweating
• headache
• decreased sexual desire, inability to get or keep an erection
• itching

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• chest pain, changes in heartbeat
• seizures
• rash; hives; itching; nausea; vomiting; hoarseness; difficulty breathing or swallowing; or swelling of the hands, eyes, face, lips, mouth, tongue or throat
• extreme drowsiness
• new pain or pain from touch or doing ordinary tasks such as combing your hair
• difficulty swallowing, regurgitation (bringing up swallowed food into throat and mouth), pain in the chest area
• unusual snoring or long pauses during breaths during sleep

Oxymorphone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children, and in a location that is not easily accessible by others, including visitors to the home. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, flush any medication that is outdated or no longer needed down the toilet so that others will not take it. Talk to your pharmacist about the proper disposal of your medication.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• difficulty breathing or slow or shallow breathing
• cold, clammy skin
• increase or decrease in pupil (dark circle in the eye) size
• unusual snoring
• slowed heartbeat
• sleepiness, unable to respond or wake up

What other information should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking oxymorphone.

This prescription is not refillable. If you are taking oxymorphone to control your pain on a long term basis, be sure to schedule appointments with your doctor regularly so that you do not run out of medication. If you are taking oxymorphone on a short term basis, call your doctor if you continue to have pain after you finish the medication.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

• Opana^®¶
• Opana^® ER¶
• also available generically