oxymorphone

Generic Name: oxymorphone (ox ee MOR fone)
Brand names: Opana, Opana ER, Numorphan HCl

What is oxymorphone?

Oxymorphone is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Oxymorphone is used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain.

Oxymorphone is not for treating pain just after surgery unless you were already taking oxymorphone before the surgery.

Oxymorphone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about oxymorphone?

Oxymorphone may be habit-forming and should be used only by the person it was prescribed for. Oxymorphone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking oxymorphone. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol. Never take more than your prescribed dose of oxymorphone. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Oxymorphone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before using oxymorphone?

Do not use this medication if you are allergic to oxymorphone, if you have severe liver disease, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus. You should also not take oxymorphone if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methadone, morphine, Oxycontin, Darvocet, Percocet, Vicodin, Lortab, and many others). Oxymorphone may be habit-forming and should be used only by the person it was prescribed for. Oxymorphone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using oxymorphone, tell your doctor if you are allergic to any drugs, or if you have:

• asthma, COPD, sleep apnea, or other breathing disorders;

• liver or kidney disease;

• underactive thyroid;

• curvature of the spine;

• a history of head injury or brain tumor;

• epilepsy or other seizure disorder;

• a pancreas disorder;

• Addison's disease or other adrenal gland disorders;

• enlarged prostate, urination problems;

• mental illness; or

• a history of drug or alcohol addiction.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Oxymorphone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more sensitive to the effects of this medicine.

How should I use oxymorphone?

Take this medication exactly as it was prescribed for you. Never take oxymorphone in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It will release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. The Opana ER tablet should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal. Tell your doctor if you feel sick after taking the medicine on an empty stomach. Do not stop using oxymorphone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store this medication at room temperature, away from heat, moisture, and light.

Keep track of how many tablets have been used from each new bottle of this medicine. Oxymorphone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet.

What happens if I miss a dose?

Since oxymorphone is sometimes used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Extended-release oxymorphone is not for use on an as-needed basis for pain.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of oxymorphone can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while using oxymorphone?

Do not drink alcohol while you are using oxymorphone. Dangerous side effects or death can occur when alcohol is combined with oxymorphone. Check your food and medicine labels to be sure these products do not contain alcohol. Oxymorphone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Oxymorphone side effects

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 as:

• nausea, vomiting, constipation;

• dizziness, headache;

• dry mouth;

• sweating; or

• itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Oxymorphone Dosing Information

Usual Adult Dose for Pain:

Subcutaneous or intramuscular: 1 mg to 1.5 mg repeated every 4 to 6 hours as needed.

Intravenous: 0.5 mg as an initial dose. In non-debilitated patients the dose can be cautiously increased until satisfactory pain relief is obtained.

Rectal: one suppository (5 mg) every 4 to 6 hours. In non-debilitated patients the dose can be cautiously increased until satisfactory pain relief is obtained.

Oral Immediate Release Tablets (Opana):
Initiation of Therapy for Patients Who Are Not Opioid-Experienced:
Patients who have not been receiving opioid analgesics should be started on Opana in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity. If deemed necessary to initiate therapy at a lower dose, patients may be started with Opana 5 mg. The dose should be titrated based upon the individual patient's response to their initial dose of Opana. This dose can then be adjusted to an acceptable level of analgesia taking into account the pain intensity and side effects experienced by the patient. Initiation of therapy with doses higher than 20 mg is not recommended because of potential serious side effects.

Conversion from Parenteral Oxymorphone to Opana:
Given the absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to Opana by administering 10 times the patient's total daily parenteral oxymorphone dose as Opana, in four or six equally divided doses. The dose can be titrated to optimal pain relief or combined with acetaminophen/NSAIDs for optimal pain relief. Due to patient variability with regard to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.

Oral Extended Release Tablets (Opana ER) :
Initiation of Therapy for Patients Who Are Not Opioid-Experienced:
Chronic around-the-clock opioid therapy may be started with Opana ER 5 mg every 12 hours. Thereafter, it is recommended that the dose be individually titrated, preferably at increments of 5 to 10 mg every 12 hours every 3 to 7 days, to a level that provides adequate analgesia and minimizes side effects under the close supervision of the prescribing physician.

Initiation of Therapy for Opioid-Experienced Patients:
(Conversion from Opana to Opana ER)
Patients receiving Opana may be converted to Opana ER by administering half the patient's total daily oral Opana dose as Opana ER, every 12 hours.

Conversion from Parenteral Oxymorphone to Opana ER:
Given the absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone may be converted to Opana ER by administering 10 times the patient's total daily parenteral oxymorphone dose as Opana ER in two equally divided doses. For example, approximately 20 mg of Opana ER, every 12 hours, may be required to provide pain relief equivalent to a total daily dose of 4 mg of parenteral oxymorphone. Due to patient variability with regards to opioid analgesic response, upon conversion patients should be closely monitored to ensure adequate analgesia and to minimize side effects.

Opana ER should be administered on an empty stomach, at least one hour prior to or two hours after eating.

Usual Adult Dose for Labor Pain:

During labor: 0.5 mg to 1.0 mg intramuscularly

What other drugs will affect oxymorphone?

Do not take oxymorphone with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Before taking oxymorphone, tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are using any of these drugs, you may not be able to use oxymorphone, or you may need dosage adjustments or special tests during treatment.

This list is not complete and there may be other drugs that can interact with oxymorphone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about oxymorphone.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.05. Revision Date: 4/12/2009 4:38:25 PM.