Oxymorphone has a high risk for abuse and severe, possibly fatal, breathing problems. The risk for harm is higher if you take the wrong dose/strength, or if you take it along with other drugs that might also affect breathing. Be sure you know how to take oxymorphone and what other drugs you should avoid taking with it. The risk for breathing problems might also be higher when you start this medication and after a dose increase. Get immediate help if you notice unusual slow/shallow breathing.
This medication must be swallowed whole. Do not break, chew, dissolve, or crush the medication. This may cause a rapid release of the medication that may be fatal. Also, do not drink alcohol or take any products containing alcohol while taking this medication. This may cause an increase of the medication in your body that may be fatal.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, shaking, persistent crying, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally swallows this drug, get emergency medical help right away.Who should not take Opana ER?
This medication is used to treat severe ongoing pain. It acts on certain centers in the brain to give you pain relief. This medication is a long-acting form of a narcotic pain reliever (opiate-type).
Do not use the extended-release form of oxymorphone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
See also Warning section.
Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication on a regular schedule as directed by your doctor, not as needed for sudden (breakthrough) pain.
Take this medication by mouth without food (1 hour before or 2 hours after eating) as directed by your doctor, usually every 12 hours. Make sure to take this medication with enough water so that you swallow the tablet completely. If you have nausea, ask your doctor or pharmacist about ways to decrease nausea (e.g., lying down for 1 to 2 hours with as little head movement as possible).
The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Properly stop the medication when so directed.
You may take quick-acting narcotic pain medications for sudden (breakthrough) pain if so directed by your doctor. Also follow your doctor's or pharmacist's instructions for safely using non-narcotic pain relievers (e.g., naproxen, ibuprofen). If you have been regularly using other long-acting narcotic pain medications or narcotic patches, check with your doctor or pharmacist since they may need to be stopped before you start using this medication. If you are currently using a narcotic patch (e.g., fentanyl), the effects may continue after it is removed. Ask your doctor or pharmacist when it will be safe to start taking this medication (usually 18 hours after removing the patch).
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, irritability, tearing, runny nose, sweating, diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
Nausea, vomiting, headache, constipation, dry mouth, mild itching, lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Occasionally, a soft mass that looks like the tablet may appear in your stool. This effect is harmless because your body has already absorbed the medication.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: slow/fast heartbeat, difficulty urinating, severe stomach/abdominal pain, change in the amount of urine, shortness of breath, mental/mood changes, vision changes.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking oxymorphone, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (such as codeine, morphine, oxycodone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., head injury, tumor, seizures), breathing problems (e.g., asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (e.g., confusion, depression, thoughts of suicide), disease of the pancreas (pancreatitis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (e.g., blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (e.g., due to enlarged prostate).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Older adults may be more sensitive to the side effects of the drug, especially dizziness, drowsiness, slow/shallow breathing and confusion.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: products that contain alcohol (such as cough-and-cold syrups), certain pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol), narcotic antagonists (e.g., naltrexone).
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and other narcotic pain relievers (such as codeine, oxycodone).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
This medication may interfere with certain laboratory tests (including amylase and lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness, very small pupils.
Do not share this medication with others. It is against the law.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. See also Warning section.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. In the US, the FDA recommends flushing this medication down the toilet or pouring into a drain. Consult your pharmacist or local waste disposal company.
Information last revised September 2014. Copyright(c) 2014 First Databank, Inc.
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