Generic Name: oxymorphone (Oral route)
Opana(R) 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(R) ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Opana(R) 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.
Opana(R) ER is NOT intended for use as a prn analgesic.
Opana(R) ER tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed Opana(R) ER tablets leads to rapid release and absorption of a potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol, while on Opana(R) ER therapy. The co-ingestion of alcohol with Opana(R) ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone .
OPANA(R) ER contains oxymorphone, a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. OPANA(R) 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. Extended release tablets should be swallowed whole; not broken, chewed, dissolved, or crushed. Avoid alcohol and alcohol-containing medications as consumption of alcohol may result in increased plasma levels and a potentially fatal overdose of oxymorphone .
Commonly used brand name(s):
In the U.S.
- Opana ER
Available Dosage Forms:
- Tablet, Extended Release
Therapeutic Class: Analgesic
Chemical Class: Opioid
Uses For Opana ER
Oxymorphone is a narcotic analgesic. It acts in the central nervous system (CNS) to relieve pain. Many of its side effects are also caused by actions in the CNS .
When oxymorphone is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely. Your doctor will take this into consideration when deciding on the amount of oxymorphone you should receive .
This medicine is available only with your doctor's prescription .
Before Using Opana ER
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of oxymorphone in the pediatric population. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of oxymorphone in the elderly. However, elderly patients are more likely to have age-related liver, kidney or heart problems, which may require an adjustment of dosage in patients receiving oxymorphone .
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Morphine Sulfate Liposome
- Sodium Oxybate
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, or history of, or
- Addison's disease or
- Drug dependence, especially narcotic abuse, or history of or
- Enlarged prostate or
- Mental problems or
- Pancreatitis (swelling of the pancreas) or
- Urinating problems—The chance of side effects may be increased .
- Asthma or
- Brain disease or
- Chronic obstructive pulmonary disease (COPD) or
- Depression or
- Head injury or
- Heart disease or
- Obesity, severe or
- Scoliosis (an abnormal spine curve) or
- Sleep apnea (breathing stops during sleep) or
- Underactive thyroid—Use with caution. May increase risk of having breathing problems .
- Breathing problems (e.g., asthma attack or severe asthma) or
- Liver disease, moderate to severe or
- Paralytic ileus (blockage of the bowel)—Should not be used in patients with these conditions .
- Kidney disease or
- Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body .
- Seizures—Use with caution. This medicine may worsen this condition .
- Shock—Blood pressure–lowering effects of this medicine may be increased .
Proper Use of oxymorphone
This section provides information on the proper use of a number of products that contain oxymorphone. It may not be specific to Opana ER. Please read with care.
It is best to take this medicine on an empty stomach, at least one hour before or two hours after a meal .
Swallow the extended-release tablet whole. Do not crush, dissolve, break, or chew it .
Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Withdrawal side effects may occur when the medicine is stopped suddenly because your body has become used to this medicine .
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For pain:
- For oral dosage form (tablets):
- Adults—At first, 5 milligrams (mg) every four to six hours. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor .
- For oral dosage form (extended-release tablets):
- Adults—At first, 5 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor .
- For oral dosage form (tablets):
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Opana ER
If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.
Oxymorphone may increase your risk of having serious breathing problems. Check with your doctor right away if you are having difficult or troubled breathing; irregular, fast, slow, or shallow breathing; pale or blue lips, fingernails, or skin; or shortness of breath .
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine .
Oxymorphone may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded.
Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness .
Using this medicine for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems .
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using oxymorphone .
Opana ER Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Less common
- Blurred vision
- decreased urination
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- dry mouth
- fast, pounding, racing, or irregular heartbeat or pulse
- pounding in the ears
- rapid breathing
- shortness of breath
- sunken eyes
- swelling of hands, ankles, or feet
- tightness in chest
- unusual tiredness or weakness
- wrinkled skin
- Abdominal pain
- chest pain or discomfort
- cold sweats
- decrease in urine volume
- decrease in consciousness
- difficulty in passing urine [dribbling]
- difficulty sleeping
- difficulty swallowing
- drowsiness to profound coma
- irregular, slow, or shallow breathing
- joint pain, stiffness or swelling
- mood or other mental changes
- painful urination
- pale or blue lips, fingernails, or skin
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- redness of skin
- severe constipation
- severe vomiting
- shortness of breath
- skin rash
- swelling of eyelids, face, or lips
- trouble in holding or releasing urine
- trouble sleeping
- troubled breathing or swallowing
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
- Cold and clammy skin
- constricted, pinpoint, or small pupils [black part of eye]
- decreased awareness or responsiveness
- muscle weakness
- no blood pressure or pulse
- not breathing
- severe sleepiness or unusual drowsiness
- stopping of heart
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Difficulty having a bowel movement (stool)
- feeling of constant movement of self or surroundings
- increased sweating
- nausea or vomiting
- relaxed and calm
- sensation of spinning
- Acid or sour stomach
- decreased appetite
- decreased weight
- excess air or gas in stomach or intestines
- feeling of warmth
- feeling sad or empty
- full or bloated feeling
- lack of appetite
- loss of interest or pleasure
- passing gas
- pressure in the stomach
- redness of the face, neck, arms and occasionally, upper chest
- stomach discomfort or upset
- swelling of abdominal or stomach area
- trouble concentrating
- unable to sleep
- Blistering, crusting, irritation, itching, or reddening of skin
- cracked, dry, scaly skin
- difficulty in thinking or concentrating
- disturbed color perception
- double vision
- false or unusual sense of well-being
- feeling jittery
- halos around lights
- loss of vision
- mental depression
- night blindness
- nightmares or unusually vivid dreams
- overbright appearance of lights
- sudden sweating
- tunnel vision
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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