Oxymorphone

Oxymorphone may be habit forming, especially with prolonged use. Take oxymorphone exactly as directed. 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. While taking oxymorphone, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse oxymorphone if you have or have ever had any of these conditions. Talk to your healthcare provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Oxymorphone may cause serious or life-threatening breathing problems, especially during the first 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing, or asthma. Your doctor will probably tell you not to take oxymorphone tablets. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema), a head injury, brain tumor, any condition that increases the amount of pressure in your brain, or sleep apnea (condition in which breathing stops or becomes shallow during sleep). The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Do not allow anyone else to take your medication. Oxymorphone may harm or cause death to other people who take your medication, especially children. Store oxymorphone in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep oxymorphone out of the reach of children. Keep track of how many tablets are left so you will know if any medication is missing.

Taking certain medications other medications with oxymorphone may increase the risk that you will develop serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medication and will monitor you carefully. If you take oxymorphone with other medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with oxycodone increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.

Tell your doctor if you are pregnant or plan to become pregnant. If you take oxymorphone regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Talk to your doctor about the risks of taking oxymorphone.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with oxymorphone and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Oxymorphone immediate-release tablets are used to relieve severe, acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in people who are expected to need an opioid pain medication and who cannot be treated with other pain medications. Oxymorphone extended-release tablets are used to relieve severe and persistent pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Oxymorphone extended-release tablets should not be used to treat pain that can be controlled by medication that is taken as needed. Oxymorphone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the body responds to pain.

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. The immediate-release tablet is usually taken every 4 to 6 hours as needed for pain. The extended-release tablets are 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.

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. Talk to your doctor about how you are feeling during your treatment with oxymorphone. 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.

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.

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

Before taking oxymorphone,

• tell your doctor and pharmacist if you are allergic to oxymorphone, any other medications, or any of the ingredients in oxymorphone tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate).
• tell your doctor if you have any of the conditions mentioned in the IMPORTANT WARNING section, 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 seizures; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); problems urinating, or kidney, pancreas, thyroid, or gall bladder disease.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking oxymorphone. Oxymorphone can cause unusual sleepiness, slowed or shallow breathing, difficulty or noisy breathing, confusion, or limpness in breastfed infants.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking oxymorphone.
• 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.

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

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.

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

• dry mouth
• stomach pain or swelling
• nausea
• vomiting
• gas
• excessive sweating
• flushing
• fast heartbeat
• red eyes
• headache
• feeling anxious or confused
• 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
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire
• 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
• chest pain
• extreme drowsiness
• fainting

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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). You must immediately 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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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.

While taking oxymorphone, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. Ask your doctor about other ways that you can obtain naloxone (directly from a pharmacy or as part of a community based program). You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

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
• limp or weak muscles
• extreme sleepiness
• unusual snoring
• slowed heartbeat
• unable to respond or wake up

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), 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.

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.

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