"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Opana ER Consumer
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
OXYMORPHONE EXTENDED-RELEASE - ORAL
COMMON BRAND NAME(S): Opana ER
WARNING: 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.
USES: 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.
HOW TO 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.
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