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MEDICATION GUIDE

OPANA ER
(O-pan-a)
(oxymorphone hydrochloride) Extended-Release tablets

Read this Medication Guide completely before you start taking OPANA ER and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. Be sure to share this important information with members of your household or other caregivers.

What is the most important information I should know about OPANA ER?

OPANA ER can cause serious side effects, including addiction or death.

1. Take OPANA ER exactly as prescribed. OPANA ER is not for use to treat pain that you only have now and then (“as needed”). Do not take OPANA ER for short term pain that you expect to go away in a few days, such as pain after surgery.

2. Swallow OPANA ER tablets whole. Do not cut, break, crush, dissolve, or chew OPANA ER tablets before swallowing. If OPANA ER is taken in this way, the medicine in the tablets will be released too fast. This is dangerous. It may cause you to have trouble breathing and lead to death. If you cannot swallow OPANA ER tablets whole, tell your healthcare provider. You may need a different medicine.

3. Do not drink alcohol, or take prescription or non-prescription medicines that contain alcohol while taking OPANA ER. Taking OPANA ER with alcohol may increase your risk of dangerous side effects and lead to death.

4. OPANA ER is a federally controlled substance (CII) because it is a strong opioid (narcotic) prescription pain medicine that can be misused by people who abuse prescription medicines or street drugs.

• Prevent theft, misuse or abuse. Keep OPANA ER in a safe place to protect it from being stolen. OPANA ER can be a target for people who abuse opioid (narcotic) medicines or street drugs.
• Selling or giving away this medicine is against the law.
• Never give OPANA ER to anyone else, even if they have the same symptoms you have. It may harm them and even cause death.

What is OPANA ER?

• OPANA ER is a prescription medicine used to treat moderate to severe pain around-the-clock and is expected to last for a long period of time.
• OPANA ER is not for use:
  • to treat pain that you only have now and then “as needed”.
  • right after surgery if the pain is mild or is not expected to last for a long period of time.
• Your healthcare provider may prescribe OPANA ER for pain after surgery if:
  • you were already taking OPANA ER before surgery, or
  • your pain after surgery is expected to be moderate or severe and last for a long period of time.

It is not known if OPANA ER is safe and effective in children under 18 years of age.

Who should not take OPANA ER?

Do not take OPANA ER if you:

• are allergic to oxymorphone or any of the ingredients in OPANA ER. See the end of this Medication Guide for a complete list of ingredients in OPANA ER.
• are allergic to codeine or other medicines that are like morphine. Ask your healthcare provider or pharmacist if you are not sure.
• are having an asthma attack or have severe asthma, trouble breathing, or lung problems.
• have a bowel blockage called a paralytic ileus.
• have liver problems.

What should I tell my healthcare provider before starting OPANA ER?

Before taking OPANA ER, tell your healthcare provider if you:

• have trouble breathing or lung problems
• have a head injury or brain problems
• have liver or kidney problems
• have adrenal gland problems, such as Addison's disease
• have convulsions or seizures
• have thyroid problems
• have severe scoliosis that affect your breathing
• have problems urinating or enlargement of your prostate
• have problems with your pancreas
• have a past or present drinking problem or alcoholism or a family history of this problem
• have severe mental problems or hallucinations (see or hear things that are not really there)
• have past or present drug abuse or drug addiction problems or a family history of this problem
• have any other medical problems
• are pregnant or plan to become pregnant. OPANA ER may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if OPANA ER passes into your milk. Talk to your healthcare provider about the best way to feed your baby if you are taking OPANA ER.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with OPANA ER. Your dose of OPANA ER may need to change if used with certain other medicines.

• Be especially careful about taking other medicines that may make you sleepy, such as:
  • other pain medicines
  • sleeping pills
  • anti-anxiety medicines
  • antihistamines
  • anti-depressants
  • tranquilizers
  • anti-nausea medicine
  • cimetidine (Tagamet)
  • Monoamine Oxidase Inhibitors (MAOI). You should not take OPANA ER if you take a MAOI medicine or within 2 weeks of stopping an MAOI.
• Do not take other medicines without talking to your healthcare provider or pharmacist. Your healthcare provider or pharmacist will tell you if it is safe to take other medicines while you take OPANA ER.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take OPANA ER?

• Take OPANA ER exactly as prescribed.
• Your healthcare provider will tell you how many OPANA ER tablets to take and when to take them.
• Do not change your dose unless your healthcare provider tells you to. Do not take OPANA ER more often than prescribed.
• Do not pre-soak, lick or get your OPANA ER wet before you place it in your mouth.
• Take 1 OPANA ER tablet at a time.
• Take each OPANA ER tablet with enough water to ensure the tablet is completely swallowed right after placing it in your mouth.
• Swallow OPANA ER tablets whole. Do not cut, break, crush, dissolve, or chew OPANA ER tablets. If OPANA ER is taken in this way, the medicine in the tablet will be released too fast. This is dangerous. It may cause you to have trouble breathing and lead to death.
  If you cannot swallow OPANA ER tablets whole, tell your healthcare provider. You may need a different medicine.
• Take OPANA ER on an empty stomach, at least 1 hour before meals or 2 hours after meals. Talk to your healthcare provider if you feel sick taking OPANA ER on an empty stomach.
• If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take more than your prescribed dose of OPANA ER. If you are not sure about your dosing call your healthcare provider.
• If you take too much OPANA ER, call your healthcare provider or go to the nearest hospital emergency room right away.
• Talk to your healthcare provider regularly about your pain and tell your healthcare provider if you have pain that is not relieved with OPANA ER.
• Stopping OPANA ER. You should not stop taking OPANA ER suddenly if you have been taking it more than a few days, without talking to your healthcare provider. If your healthcare provider decides you no longer need OPANA ER, ask how to slowly stop your medicine so you do not get withdrawal symptoms such as nausea, sweating, and pain.
• OPANA ER can cause physical dependence. You can get sick with withdrawal symptoms if you stop OPANA ER suddenly, because your body has become used to it. Ask your healthcare provider if this is a concern for you.

What should I avoid while taking OPANA ER?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how OPANA ER affects you. OPANA ER can make you sleepy, and can make you feel dizzy or lightheaded. OPANA ER can also affect your ability to react. Ask your healthcare provider to tell you when it is okay to do these activities.
• Do not drink alcohol or take prescription or non-prescription drugs that contain alcohol while taking OPANA ER. Taking OPANA ER with alcohol may increase your risk of dangerous side effects and lead to death.

What are the possible side effects of OPANA ER?

OPANA ER can cause serious side effects, including:

• See “What is the most important information I should know about OPANA ER?”
• Breathing problems. Call your healthcare provider or get medical help right away if:
  • your breathing slows down
  • you have shallow breathing (little chest movement with breathing)
  • you feel faint, dizzy, confused, or have any other unusual symptoms
    These can be signs or symptoms that you have taken too much OPANA ER (overdose) or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away.
• Central nervous system effects. OPANA ER can cause central nervous system effects, including sleepiness, dizziness, passing out or becoming unconscious (coma) and death, when taken with certain other medicines. See “What should I tell my healthcare provider before starting OPANA ER?”
• Decreased blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you are taking other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lost blood or take certain other medicines.
• Physical Dependence. Do not stop taking OPANA ER or any other opioid, without talking to your healthcare provider about how to slowly stop your medicine. If you have been taking OPANA ER for more than a few days, you could become sick with withdrawal symptoms if you stop taking it suddenly, because your body has become used to the medicine. Physical dependency is not the same as drug addiction.
• The chance of abuse or addiction. This chance is higher if you are or have ever been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental health problems. Abuse or addiction is different than a physical dependence. If you have more concerns, talk to your healthcare provider for more information about abuse and addiction.

The most common side effects of OPANA ER are:

Constipation is a common side effect of opioid medicines, including OPANA ER. Talk to your healthcare provider or pharmacist about the use of laxatives and stool softeners to prevent or treat constipation while taking OPANA ER.

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of OPANA ER. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store OPANA ER?

• Keep OPANA ER in a safe place away from children and from anyone for whom it has not been prescribed.
• Store OPANA ER at room temperature 68°F to 77°F (20°C to 25°C).
• Keep OPANA ER in the childproof container that it comes in.
• Flush unused OPANA ER tablets that are no longer needed down the toilet.

General information about OPANA ER

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OPANA ER for a condition for which it was not prescribed. Never give OPANA ER to other people even if they have the same symptoms you have. It may harm them and even cause death, and is against the law.

This Medication Guide summarizes the most important information about OPANA ER. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about OPANA ER that is written for healthcare professionals. For more information about OPANA ER, go to www.endo.com or call 1-800-462-3636.

What are the ingredients in OPANA ER?

Active Ingredient: oxymorphone hydrochloride

Inactive Ingredients: hypromellose, polyethylene oxide, polyethylene glycol, α­tocopherol, citric acid, polyvinyl alcohol, titanium dioxide, macrogol and talc.

In addition, the:

5 mg, 7.5 mg and 30 mg tablets contain iron oxide red.
7.5 mg tablets contain iron oxide black, and iron oxide yellow.
10 mg tablets contain FD&C yellow No. 6.
20 mg tablets contain FD&C blue No. 1, FD&C yellow No. 6, and D&C yellow No. 10.
40 mg tablets contain FD&C yellow No. 6, and D&C yellow No. 10.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 12/28/2011
This monograph has been modified to include the generic and brand name in many instances.