Opana ER (generic: oxymorphone) is a prescription medication used to treat moderate to severe constant pain. Opana ER belongs to a group of drugs called opiate analgesics. It works by changing the way the body responds to pain.
This medication comes in tablet form. It is usually taken every 12 hours, on an empty stomach. Swallow Opana ER tablets whole.
Common side effects of Opana ER include nausea, constipation, and dizziness. Do not drive or operate heavy machinery until you know how Opana ER affects you.
Opana ER is a prescription medication used to treat moderate to severe constant (around-the-clock) pain that is expected to last for an extended period of time.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Opana ER can cause trouble breathing.
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 that you have taken too much Opana ER (overdose) or the dose is too high for you, which can be dangerous and lead to death if not treated.
Opana ER can cause your blood pressure to drop. 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.
Opana ER can cause physical dependence. Your body will get used to Opana ER if you take it more than a few days. You can get sick with withdrawal symptoms if you stop taking Opana ER all at once. You can avoid getting sick with withdrawal symptoms by stopping Opana ER slowly. Your healthcare provider will tell you how to do this.
There is a chance of abuse or addiction with Opana ER. Abuse or addiction is different than a physical dependence. If you have abused prescription medicines, street drugs or alcohol in the past, you may have a higher chance of developing abuse or addiction again while using Opana ER. 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 nausea, constipation, dizziness, vomiting, itching, sleepiness, headache, increased sweating, and sedation. Some of these side effects may decrease with continued use. Talk to your healthcare provider if you continue to have these side effects.
Constipation (decrease in the usual number of hard bowel movements) is a common side effect of opioid medicines, including Opana ER. Talk to your healthcare provider or pharmacist about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Opana ER.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- other opiod narcotics
- sedatives, sleeping pills, tranquilizers
- buprenorphine (Buprenex, Butrans, Subutex, in Suboxone)
- butorphanol (Stadol)
- pentazocine (Talwin)
- cimetidine (Tagamet)
- MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Eldepryl, Zelapar) and tranylcypromine (Parnate)
Do not take Opana ER if:
- You had surgery within the past day (24 hours) and you were not taking Opana ER before your surgery.
- Your pain is mild or will go away in a few days.
- Your pain can be controlled by the occasional use of other pain medicines.
- You are having an asthma attack or have severe asthma, trouble breathing, or lung problems.
- You have liver problems.
- You are allergic to Opana ER or anything in it. See the end of this leaflet for a complete list of ingredients in Opana ER.
- You have had severe allergic reactions to other narcotic pain medicines (such as morphine or codeine medicines). A severe allergic reaction includes a severe rash, hives, breathing problems, or dizziness.
- Opana ER is not for children under 18 years of age.
Do not drive, operate heavy machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine. Opana ER can make you sleepy. Ask your healthcare provider to tell you when it is okay to do these activities.
Do not drink alcohol while using Opana ER. It may increase the chance of having dangerous side effects including overdose and death.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Opana ER there are no specific foods that you must exclude from your diet when receiving Opana ER.
Tell your healthcare provider about all of your medical problems, especially 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 problems urinating or prostate problems
- have pancreas problems
- have a drinking problem or alcoholism
- 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
- are pregnant or plan to become pregnant. Opana ER may harm your unborn baby.
- are breastfeeding. Opana ER may pass through your milk and may harm your baby. You should not breastfeed while 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 problems when taken with Opana ER, especially if they cause sleepiness (like sleeping pills, anxiety medicines, antihistamines, or tranquilizers).
Do not take any new medicines while using Opana ER until you have talked to your healthcare provider or pharmacist and they have told you it is safe.
Tell your doctor if you are pregnant or plan to become pregnant. Opana ER may harm your unborn baby.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Opana ER is excreted in human breast milk or if it will harm your nursing baby.
- Follow your healthcare provider’s directions exactly. Your healthcare provider may change your dose based on your reactions to the medicine. Do not change your dose unless your healthcare provider tells you to change it. Do not take Opana ER more often than prescribed.
- Swallow Opana ER tablets whole. Do not break, crush, dissolve, or chew Opana ER tablets before swallowing. If a tablet is broken, crushed, dissolved, or chewed, the full 12 hour dose can be taken into your body all at once. This is very dangerous. You could die from an overdose of the medicine. If you cannot swallow tablets whole, tell your healthcare provider. You may need a different medicine.
- Take Opana ER every 12 hours or as instructed by your healthcare provider. Opana ER should be taken on an empty stomach, at least one hour before or two 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 2 doses at once unless your healthcare provider tells you to. If you are not sure about your dosing call your healthcare provider.
- If you take too much Opana ER or overdose, call your local emergency number or poison control center right away.
- Talk to your healthcare provider often about your pain. Your healthcare provider can decide if you still need Opana ER.
- If you have side effects that bother you or if you continue to have pain, call your healthcare provider.
- Stopping Opana ER. If your healthcare provider decides you no longer need Opana ER, ask how to slowly reduce the dose of your medicine so you don’t get uncomfortable (withdrawal) symptoms such as nausea, sweating, and pain. You should not stop taking Opana ER all at once if you have been taking it for more than a few days without talking to your healthcare provider. Opana ER can cause physical dependence. You can get sick with withdrawal symptoms if you stop Opana ER all at once, because your body has become use to it.
Take Opana ER exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of Opana ER must be individualized.
If you take too much Opana ER, call your local Poison Control Center or seek emergency medical attention right away. Symptoms of overdose may include the following:
- breathing problems or slowed or stopped breathing
- limp, weak muscles
- cold, clammy skin
- increase or decrease in pupil (dark circle in the eye) size
- slow heart rate
- low blood pressure
Opana ER tablets are available in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg strengths.
Active Ingredient: oxymorphone hydrochloride
Inactive Ingredients: hypromellose, methylparaben, silicified microcrystalline cellulose, sodium stearyl fumarate, TIMERx-N, titanium dioxide, and triacetin. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets also contain macrogol, and polysorbate 80. In addition, the 5 mg, 7.5 mg, and 30 mg tablets contain iron oxide red. The 7.5 mg tablets contain iron oxide black, and iron oxide yellow. The 10 mg tablets contain FDandC yellow No. 6. The 20 mg tablets contain FDandC blue No. 1, FDandC yellow No. 6, and DandC yellow No. 10. The 40 mg tablets contain FDandC yellow No. 6, DandC yellow No.10, and lactose monohydrate.
- Store Opana ER at room temperature between 59F to 86F (15to 30C).
- Keep Opana ER in a childproof container and store in a safe place to protect it from being stolen.
- Keep Opana ER out of the reach of children. Accidental overdose in children is an emergency and can result in death.
Opana ER is a controlled substance (CII) because it contains a narcotic painkiller that can be a target for people who abuse prescription medicines or street drugs. Keep your tablets in a safe place to protect them from being stolen. Never give your tablets to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others, even causing death, and is against the law.
WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE.
Potential for Abuse
Opana ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Opana ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Proper Patient Selection
Opana ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Limitations of Use
Opana ER is NOT intended for use as an as needed analgesic.
Opana ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed Opana ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on Opana ER therapy. The co-ingestion of alcohol with Opana ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.