Opana ER

Pronunciation

Generic Name: oxymorphone (Oral route)

ox-i-MOR-fone

Oral route(Tablet, Extended Release)

Use of oxymorphone hydrochloride extended-release tablets increases the risk of opioid addiction, abuse, or misuse, which may cause overdose or death. Assess the risk prior to therapy and monitor for signs of addiction, abuse, or misuse during therapy. Serious, life-threatening, or fatal respiratory depression may occur, particularly at treatment initiation and with dose increases. Monitor for signs of respiratory depression during treatment. Instruct patients on proper administration to reduce the risk of accidental overdose. Accidental ingestion can result in a fatal overdose, especially in children. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome, which may be life-threatening if unnoticed and untreated. If prolonged use is required in a pregnant woman, advise patient of fetal risk and ensure treatment availability. Instruct patients to avoid alcohol and alcohol-containing products as concomitant use may increase exposure and potentially cause a fatal overdose .

Commonly used brand name(s)

In the U.S.

  • Opana
  • Opana ER

Available Dosage Forms:

  • Tablet, Extended Release
  • Tablet

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Opana ER

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".

Slideshow: Are You at Risk of Prescription Drug Addiction?

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.

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:

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

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.

Breast Feeding

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

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

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. 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 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.

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 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.

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.

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
  • confusion
  • decreased urination
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast, pounding, racing, or irregular heartbeat or pulse
  • headache
  • nervousness
  • pounding in the ears
  • rapid breathing
  • sunken eyes
  • sweating
  • swelling of the hands, ankles, or feet
  • thirst
  • tightness in the chest
  • unusual tiredness or weakness
  • wrinkled skin
Rare
  • Abdominal or stomach pain
  • chest pain or discomfort
  • chills
  • cold sweats
  • cough
  • decrease in consciousness
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • difficulty with sleeping
  • difficulty with swallowing
  • disorientation
  • drowsiness to profound coma
  • fever
  • hallucination
  • hives, itching, or skin rash
  • hyperventilation
  • hoarseness
  • irregular, slow, or shallow breathing
  • irritability
  • irritation
  • joint pain, stiffness, or swelling
  • lethargy
  • 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 the skin
  • restlessness
  • severe constipation
  • severe vomiting
  • shaking
  • trouble in holding or releasing urine

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 the 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
  • sleepiness
Less common
  • Acid or sour stomach
  • belching
  • decreased appetite
  • decreased weight
  • diarrhea
  • discouragement
  • excess air or gas in the stomach or intestines
  • feeling of warmth
  • feeling sad or empty
  • full or bloated feeling
  • heartburn
  • indigestion
  • 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 the abdominal or stomach area
  • tiredness
  • trouble concentrating
Rare
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry, scaly skin
  • difficulty with 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
  • 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.

See also: Side effects (in more detail)

The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products.

Copyright 2014 Truven Health Analytics, Inc. All Rights Reserved.

Hide
(web1)