Oxymorphone (patient information)

IMPORTANT WARNING

• Oxymorphone may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time or in a different way than prescribed by your doctor. Taking more oxymorphone than prescribed by your doctor may cause overdose and death, especially if you also overuse other prescription medications or use street drugs or alcohol. Tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs or have overused prescription medication.
• Oxymorphone extended-release (long-acting) tablets should be used only by people who need regularly scheduled doses of pain medication to treat continuous pain for an extended period of time. Extended-release oxymorphone tablets should not be taken as needed or to treat occasional episodes of pain.
• Swallow oxymorphone extended-release tablets whole; do not break, chew, dissolve, or crush them. If you take broken, chewed, dissolved, or crushed extended-release tablets, you will receive the entire dose of oxymorphone at once, instead of slowly over 12 hours. This may cause serious problems, including overdose and death. Tell your doctor if you are unable to swallow the tablets whole. Your doctor may prescribe a different medication.
• Do not drink any drinks that contain alcohol or take any prescription or nonprescription medications that contain alcohol while you are taking oxymorphone, especially while you are taking the extended-release tablets. Ask your doctor or pharmacist or check the list of ingredients if you do not know if a medication contains alcohol. Taking alcohol with extended-release oxymorphone tablets may cause an increased amount of oxymorphone in your body and could cause an overdose or death.
• Talk to your doctor about the risks of taking oxymorphone.

Why is this medication prescribed?

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

How should this medicine be used?

• Oxymorphone comes as a tablet and an extended-release tablet to take by mouth on an empty stomach, at least 1 hour before or 2 hours after meals. The regular tablet is usually taken every 4 to 6 hours. The extended-release tablet is usually taken every 12 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxymorphone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
• Your doctor will probably start you on a low dose of oxymorphone and gradually increase your dose until your pain is controlled. Your doctor may adjust your dose at any time during your treatment if your pain is not controlled. If you feel that your pain is not controlled, call your doctor. Do not change the dose of your medication without talking to your doctor.
• 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.

Other uses for this medicine

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

What special precautions should I follow?

• Before taking oxymorphone,

• Tell your doctor and pharmacist if you are allergic to oxymorphone, oxycodone (Oxy IR, OxyContin, in Percocet, in Tylox, others), codeine (in many pain relievers and cough medications), hydrocodone (in Hycodan, in Lortab, in Vicoprofen, others), dihydrocodeine (in Synalgos-DC, others), hydromorphone (Dilaudid, Exalgo), any other medications, or any of the ingredients in oxymorphone tablets or extended-release tablets. :* Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; buprenorphine (Buprenex, Butrans, Subutex, in Suboxone); butorphanol (Stadol); cimetidine (Tagamet); ipratropium (Atrovent); medications for anxiety, irritable bowel disease, mental illness, motion sickness, nausea, Parkinson's disease, seizures, ulcers, or urinary problems; nalbuphine; narcotic medications for pain; pentazocine (Talwin); sedatives; sleeping pills; and tranquilizers. Also tell your doctor or pharmacist if you are taking any of the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Eldepryl, Zelapar), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have asthma, lung disease, chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), slowed breathing, liver disease, 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 are very overweight and if you have or have ever had a head injury; a tumor in your brain or nervous system; any condition causing increased pressure in your brain; hypothyroidism (condition in which the thyroid gland produces less hormone than normal); delirium tremens (severe withdrawal symptoms that may occur in people who drank large amounts of alcohol over time and have stopped drinking); kyphoscoliosis (curving of the spine that may cause breathing problems); low blood pressure; Addison's disease (condition in which the adrenal gland does not produce enough hormone); seizures; severe changes in mental health due to a medication; sleep apnea (condition in which breathing stops or becomes shallow during sleep); urethral stricture (blockage of the tube that allows urine to leave the body); enlarged prostate (a male reproductive gland); or heart, kidney, pancreas, or biliary tract (tubes that move bile from the liver and gallbladder to the intestine) disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking oxymorphone, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are 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 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 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.

What side effects can this medication cause?

• Oxymorphone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Constipation
• Nausea
• Vomiting
• Loss of appetite
• Dry mouth
• Stomach pain
• Headache
• Dizziness
• Confusion
• Extreme tiredness
• Difficulty falling asleep or staying asleep
• Itching
• Fever

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately

• Slow or difficult breathing
• Seizures
• Hives

• 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 [at http://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. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Flush any medication that is outdated or no longer needed down the toilet. Talk to your pharmacist about the proper disposal of your medication.
• Store oxymorphone in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.

In case of emergency/overdose

• In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following

• Difficulty breathing or slowed or stopped breathing
• Bluish-tinged skin, lips, or fingernails
• Cold, clammy skin
• Increase or decrease in pupil (dark circle in the eye) size
• Limp or weak muscles
• Extreme sleepiness
• Loss of consciousness

What other information should I know?

• Keep all appointments with your doctor.
• Do not let anyone else take your medication. Selling or giving away this medication may cause severe harm or death to others and is illegal.
• 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.
• It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

• Opana®
• Opana® ER