Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Opana
  2. Opana ER

Descriptions


Oxymorphone is used to relieve pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). It acts in the central nervous system (CNS) to relieve pain. Many of its side effects are also caused by actions in the CNS.

Oxymorphone extended-release tablets are used to relieve moderate to severe pain in patients requiring continuous, around-the-clock treatment for a long period of time, and should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain, or in situations when non-narcotic medication is effective. This medicine should not be used to treat pain that you only have once in a while or "as needed".

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.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet, Extended Release
  • Tablet

Before Using

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:

Allergies

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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxymorphone in the elderly. However, elderly patients are more likely to have unwanted effects (eg, confusion, dizziness, drowsiness, nausea) and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving oxymorphone.

Pregnancy

Information about this oxymorphone-oral-route
Pregnancy Category Explanation
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.

Breastfeeding

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.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

  • Naltrexone

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.

  • Acepromazine
  • Alfentanil
  • Alprazolam
  • Alvimopan
  • Amisulpride
  • Amitriptyline
  • Amobarbital
  • Amoxapine
  • Anileridine
  • Aripiprazole
  • Asenapine
  • Atropine
  • Baclofen
  • Belladonna
  • Benperidol
  • Benztropine
  • Biperiden
  • Bromazepam
  • Brompheniramine
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Carphenazine
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Cimetidine
  • Clemastine
  • Clidinium
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Codeine
  • Cyclobenzaprine
  • Cyclopentolate
  • Cyproheptadine
  • Darifenacin
  • Desipramine
  • Dexmedetomidine
  • Dezocine
  • Diacetylmorphine
  • Diazepam
  • Dichloralphenazone
  • Dicyclomine
  • Difenoxin
  • Dihydrocodeine
  • Dimenhydrinate
  • Diphenhydramine
  • Diphenoxylate
  • Doxepin
  • Doxylamine
  • Droperidol
  • Enflurane
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Fentanyl
  • Fesoterodine
  • Flavoxate
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fospropofol
  • Glycopyrrolate
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Homatropine
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Hyoscyamine
  • Imipramine
  • Ipratropium
  • Isoflurane
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Levorphanol
  • Loratadine
  • Lorazepam
  • Lormetazepam
  • Loxapine
  • Meclizine
  • Medazepam
  • Melperone
  • Mepenzolate
  • Meperidine
  • Mephobarbital
  • Meptazinol
  • Mesoridazine
  • Methadone
  • Methdilazine
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Methylnaltrexone
  • Midazolam
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nalmefene
  • Nalorphine
  • Naloxegol
  • Naloxone
  • Nicomorphine
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxitropium Bromide
  • Oxybutynin
  • Oxycodone
  • Oxymorphone
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Pentazocine
  • Pentobarbital
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenobarbital
  • Pimozide
  • Pipenzolate Bromide
  • Piperacetazine
  • Pipotiazine
  • Pirenzepine
  • Piritramide
  • Prazepam
  • Primidone
  • Prochlorperazine
  • Procyclidine
  • Promazine
  • Promethazine
  • Propantheline
  • Propiverine
  • Propofol
  • Propoxyphene
  • Protriptyline
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Remifentanil
  • Remoxipride
  • Samidorphan
  • Scopolamine
  • Secobarbital
  • Sertindole
  • Sodium Oxybate
  • Solifenacin
  • Stramonium
  • Sufentanil
  • Sulpiride
  • Tapentadol
  • Temazepam
  • Terodiline
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Thiothixene
  • Tilidine
  • Tiotropium
  • Tizanidine
  • Tolonium Chloride
  • Tolterodine
  • Topiramate
  • Tramadol
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trihexyphenidyl
  • Trimeprazine
  • Trimipramine
  • Tropicamide
  • Trospium
  • Umeclidinium
  • Zaleplon
  • Zolpidem
  • Zopiclone
  • Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Perampanel

Other Interactions

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

  • Ethanol

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:

  • Addison's disease (adrenal gland problem) or
  • Alcohol abuse, or history of or
  • Brain tumor or
  • Breathing or lung problems (eg, hypoxia, sleep apnea) or
  • Central nervous system (CNS) depression, history of or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Drug dependence, especially with narcotics, history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Head injuries, history of or
  • Hypothyroidism (an underactive thyroid) or
  • Kyphoscoliosis (curvature of spine with breathing problems) or
  • Mental illness, or history of or
  • Obesity, severe or
  • Problems with passing urine or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Asthma, severe or
  • Hypercarbia (high carbon dioxide in the blood), severe or
  • Liver disease, moderate to severe or
  • Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.
  • Gallbladder disease or
  • Hypotension (low blood pressure) or
  • Hypovolemia (low blood volume) or
  • Pancreatitis (inflammation or swelling of the pancreas) or
  • Seizures, history of or
  • Stomach or bowel blockage—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Paralytic ileus (intestine stops working and may be blocked)—Opana® ER should not be given in patients with this condition.
  • Shock—Blood pressure–lowering effects of this medicine may be increased.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

It is best to take this medicine on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you are using the extended-release tablets:

  • Take the tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Do not crush, break, cut, dissolve, lick, or chew it.
  • While taking this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
  • This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

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 oral dosage form (extended-release tablets):
    • For moderate to severe pain:
      • For patients who are not taking narcotic medicines:
        • Adults—At first, 5 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
      • For patients switching from Opana® to Opana® ER:
        • Adults—At first, the dose is half of the total oral Opana® that you are taking per day, every 12 hours. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
      • For patients switching from oxymorphone injection to Opana® ER:
        • Adults—At first, the dose is 10 times the total oxymorphone injection dose that you are receiving per day divided into two equal doses. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
      • For patients switching from oral opioids to Opana® ER:
        • Adults—At first, the dose is half of the total daily dose that you are taking per day, every 12 hours. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For pain:
      • Adults—At first, 5 milligrams (mg) every 4 to 6 hours. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Storage

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.

Oxymorphone can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush all unused medicine down the toilet after you have finished your treatment. Also flush old medicine after the expiration date has passed. This medicine is one of only a few medicines that should be disposed of this way.

Precautions

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.

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

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, medicine for seizures or barbiturates, 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.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

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, not alert, or lightheaded.

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.

If you have been using this medicine regularly for several weeks or more, do not change your dose or suddenly stop using it 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.

Tell your doctor if you are pregnant or plan to become pregnant while taking this medication. Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby, which can be life-threatening. Tell your doctor right away if your baby has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

  1. Blurred vision
  2. confusion
  3. decreased urination
  4. difficult or labored breathing
  5. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  6. dry mouth
  7. fast, pounding, racing, or irregular heartbeat or pulse
  8. headache
  9. nervousness
  10. pounding in the ears
  11. rapid breathing
  12. sunken eyes
  13. sweating
  14. swelling of the hands, ankles, or feet
  15. thirst
  16. tightness in the chest
  17. unusual tiredness or weakness
  18. wrinkled skin

Rare

  1. Abdominal or stomach pain
  2. chest pain or discomfort
  3. chills
  4. cold sweats
  5. cough
  6. decrease in consciousness
  7. decrease in urine volume
  8. difficulty in passing urine (dribbling)
  9. difficulty with sleeping
  10. difficulty with swallowing
  11. disorientation
  12. drowsiness to profound coma
  13. fever
  14. hallucination
  15. hives, itching, or skin rash
  16. hyperventilation
  17. hoarseness
  18. irregular, slow, or shallow breathing
  19. irritability
  20. irritation
  21. joint pain, stiffness, or swelling
  22. lethargy
  23. painful urination
  24. pale or blue lips, fingernails, or skin
  25. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  26. redness of the skin
  27. restlessness
  28. severe constipation
  29. severe vomiting
  30. shaking
  31. trouble in holding or releasing urine

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Cold and clammy skin
  2. constricted, pinpoint, or small pupils (black part of the eye)
  3. decreased awareness or responsiveness
  4. muscle weakness
  5. no blood pressure or pulse
  6. not breathing
  7. severe sleepiness or unusual drowsiness
  8. 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

  1. Difficulty having a bowel movement (stool)
  2. feeling of constant movement of self or surroundings
  3. increased sweating
  4. nausea or vomiting
  5. relaxed and calm
  6. sensation of spinning
  7. sleepiness

Less common

  1. Acid or sour stomach
  2. belching
  3. decreased appetite
  4. decreased weight
  5. diarrhea
  6. discouragement
  7. excess air or gas in the stomach or intestines
  8. feeling of warmth
  9. feeling sad or empty
  10. full or bloated feeling
  11. heartburn
  12. indigestion
  13. lack of appetite
  14. loss of interest or pleasure
  15. passing gas
  16. pressure in the stomach
  17. redness of the face, neck, arms, and occasionally, upper chest
  18. stomach discomfort or upset
  19. swelling of the abdominal or stomach area
  20. tiredness
  21. trouble concentrating

Rare

  1. Blistering, crusting, irritation, itching, or reddening of the skin
  2. cracked, dry, scaly skin
  3. difficulty with thinking or concentrating
  4. disturbed color perception
  5. double vision
  6. false or unusual sense of well-being
  7. feeling jittery
  8. halos around lights
  9. loss of vision
  10. mental depression
  11. night blindness
  12. nightmares or unusually vivid dreams
  13. overbright appearance of lights
  14. sudden sweating
  15. tunnel vision
  16. welts

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.