Opana ER

See also Warning section. This medication is used to treat moderate-to-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). This medication should not be used during the first 12 to 24 hours after surgery if you were not taking this medication or another strong narcotic pain medication (e.g., morphine) before surgery. It should also not be used if the pain is mild or not expected to last for a long time.

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.

See also Warning section. Take this medication by mouth without food (1 hour before or 2 hours after eating), usually every 12 hours or as directed by your doctor. If you have nausea and take this drug with food, your body may absorb more of the drug and increase the risk of side effects. Consult your doctor or pharmacist about other ways to decrease nausea (e.g., antihistamines, lying down for 1-2 hours with as little head movement as possible). The dosage is based on your medical condition and response to therapy. 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. Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Inform your doctor if your pain persists or worsens.

Your health care professionals may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. This drug should not be used with the following medication because very serious interactions may occur: naltrexone. If you are currently using this medication listed above, tell your doctor or pharmacist before starting oxymorphone. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergic medications (e.g., scopolamine), cimetidine, drugs that lower blood pressure (e.g., "water pills"/diuretics such as hydrochlorothiazide, furosemide), other medications for pain (e.g., pentazocine, nalbuphine), MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine). Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, phenothiazines (e.g., prochlorperazine, chlorpromazine), psychiatric medicines (e.g., risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. 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. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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 overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness, very small pupils.

Before taking oxymorphone, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., codeine, morphine); 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercarbia, severe asthma), certain bowel diseases (e.g., paralytic ileus, infectious diarrhea), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives), moderate/severe liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat), lung diseases (e.g., chronic obstructive pulmonary disease-COPD, mild asthma, hypoxia, hypercapnia), disease of the pancreas (e.g., pancreatitis), mental/mood disorders (e.g., toxic psychosis), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, kidney disease, mild liver disease, adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), severe obesity, underactive thyroid (hypothyroidism), intestinal diseases (e.g., colitis), recent bowel/abdominal surgery. Before having surgery, tell your doctor or dentist that you are using this medication. 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. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing and drowsiness. During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. 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. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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 prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener). 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 immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, shortness of breath, mental/mood changes, fainting, vision changes. Tell your doctor immediately if any of these rare but very serious side effects occur: slow/fast heartbeat, difficulty urinating, severe stomach/abdominal pain, change in the amount of urine, seizures. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

This medication provides ongoing control of moderate-to-severe pain that is expected to last for a long time. It should be used on a regular schedule as prescribed by your doctor, not as needed. 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. 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. Get immediate help if you notice unusual slow/shallow breathing. 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.