" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
(oxymorphone hydrochloride) Extended-release Tablets, for Oral use
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short-term (acute) pain when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
- An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about OPANA:
- Get emergency help right away if you take too much OPANA (overdose). When you first start taking OPANA, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
- Taking OPANA with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- Never give anyone your OPANA. They could die from taking it. Store OPANA away from children and in a safe place to prevent stealing or abuse. Selling or giving away OPANA is against the law.
Do not take OPANA if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
Before taking OPANA, tell your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Prolonged use of OPANA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- breastfeeding. OPANA passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking OPANA with certain other medicines can cause serious side effects that could lead to death.
When taking OPANA:
- Do not change your dose. Take OPANA exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- OPANA should be taken on an empty stomach, at least one hour prior to or two hours after eating.
- Take your prescribed dose at the same time every day. Do not take more than your prescribed dose.
- If you miss a dose, take your next dose at your usual time.
- Call your healthcare provider if the dose you are taking does not control your pain.
- If you have been taking OPANA regularly, do not stop taking OPANA without talking to your healthcare provider.
- After you stop taking OPANA, flush any unused tablets down the toilet.
While taking OPANA DO NOT:
- Drive or operate heavy machinery, until you know how OPANA affects you. OPANA can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with OPANA may cause you to overdose and die.
The possible side effects of OPANA:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat or hands, hives, itching, rash, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of OPANA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Last reviewed on RxList: 1/3/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Opana Information
Opana - User Reviews
Opana User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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