Opana ER (Oral)

Oxymorphone is used to relieve pain that is severe enough to need opioid treatment, especially when other pain medications haven't worked well or can't be tolerated. Oxymorphone is part of a group of medicines called narcotic analgesics (pain medicines). It works in the central nervous system (CNS) to relieve pain, and many side effects come from its effects on the CNS.

Oxymorphone extended-release tablets are meant for relieving moderate to severe pain in patients who need continuous, around-the-clock treatment for a long time. They should not be used if you only need pain medicine for a short time, like after surgery. Do not use this medicine for mild pain or when a non-narcotic medication is effective. This medicine should not be used for pain that happens only occasionally or "as needed."

Using oxymorphone for a long time may lead to habit-forming effects (causing mental or physical dependence). However, people with ongoing pain should not avoid using narcotics to manage their pain because of concerns about dependence. Mental dependence (addiction) is unlikely when narcotics are used for pain relief. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly, but severe withdrawal side effects can usually be avoided by gradually reducing the dose over time before stopping completely.

This medicine is available only through a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause problems with your adrenal glands. Check with your doctor right away if you notice darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Oxymorphone may increase your risk of having serious breathing problems. Check with your doctor right away if you are having difficulty breathing, irregular breathing that is fast, slow, or shallow, or if you see pale or blue lips, fingernails, or skin.

Using too much oxymorphone may lead to an overdose, which can be life-threatening. Symptoms of an overdose include: changes in consciousness, extreme dizziness or weakness, loss of consciousness, pale or blue lips, fingernails, or skin, slow heartbeat or breathing, seizures, trouble breathing, cold, clammy skin, sleepiness or unusual drowsiness. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.

This medicine may cause sleep-related breathing problems (for example, sleep apnea or sleep-related hypoxemia). Your doctor may lower your dose if you have sleep apnea (which means you stop breathing for short periods during sleep) while using this medicine.

Do not use this medicine if you are currently using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®] within the past 14 days.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants include antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, sleeping medicines, other prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these other medicines while you are using this medicine.

This medicine may be habit-forming. If you believe the medicine is not working as well, do not take more than your prescribed dose. Call your doctor for guidance.

Oxymorphone may make some people feel drowsy, dizzy, or lightheaded, or give a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or even fainting may happen when you stand up quickly from lying or sitting down. Getting up slowly may help reduce this issue. Lying down for a while may also relieve dizziness or lightheadedness.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or if you see or hear things that are not there. These may be signs of a serious condition called serotonin syndrome. Your risk may be higher if you are also taking certain other medicines that affect serotonin levels in your body.

Using this medicine for a long time can lead to severe constipation. To prevent this, your doctor may advise you to take laxatives, drink plenty of fluids, or increase the fiber in your diet. Make sure to follow these directions carefully, because ongoing 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 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 your dose before stopping completely or to take another narcotic temporarily to lessen the chance of withdrawal side effects (for example, anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble sleeping).

Using this medicine while you are pregnant may lead to neonatal withdrawal syndrome in your newborn baby, which can be life-threatening. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

For nursing mothers taking this medicine:

• Talk to your doctor if you have any questions about taking oxymorphone or how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
• Check with your doctor, hospital emergency room, or local emergency services (for example, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and require immediate medical attention.

Using too much of this medicine may lead to infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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

In deciding to use a drug, the risks of taking the medication must be weighed against the good it will do. This is a decision you and your physician will make. For this drug, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other drugs. Also inform 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, heart, or lung issues, which may require caution and an adjustment in the dose for patients receiving oxymorphone.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances prior to using this medicine while breastfeeding.

Interactions with Medications

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 clinician may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially critical that your healthcare professional know if you are taking any of the medications 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.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this drug with any of the following medicines is typically not advised, but may be required in some cases. If both medications are prescribed together, your doctor may change the dose or how frequently you use one or both of the drugs.

• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Alvimopan
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Anileridine
• Aripiprazole
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Cimetidine
• Citalopram
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cocaine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Eletriptan
• Enflurane
• Escitalopram
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Imipramine
• Iproniazid
• Isocarboxazid
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lorazepam
• Lorcaserin
• Loxapine
• Magnesium Oxybate
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Methylnaltrexone
• Metoclopramide
• Midazolam
• Milnacipran
• Mirtazapine
• Moclobemide
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nalorphine
• Naloxone
• Naratriptan
• Nefazodone
• Nialamide
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Ozanimod
• Paliperidone
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 medications 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 drug with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your physician may change the dose or how frequently you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical issues may affect the use of this medication. Make sure you inform your doctor if you have any other medical issues, especially:

• Addison disease (adrenal gland problem) or
• Alcohol abuse, or history of or
• Brain tumor or
• Breathing or lung issues (eg, COPD, hypoxia, sleep apnea) or
• Cor pulmonale (serious heart condition) or
• Depression, history of or
• Drug dependence, especially narcotic abuse or dependence, 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 severe side effects.

• Gallbladder disease or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume) or
• Pancreatitis (swelling of the pancreas) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease, slight—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, moderate to serious or
• Lung or breathing issues (eg, asthma, respiratory depression), severe or
• Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects happen:

Less common

• Blurred vision
• confusion
• decreased urination
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting
• 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

• Chest pain or discomfort
• chills
• cold sweats
• confusion about identity, place, and time
• cough
• decrease in consciousness
• deep or fast breathing with dizziness
• difficulty in passing urine (dribbling)
• difficulty with sleeping
• difficulty with swallowing
• drowsiness to profound loss of consciousness
• fever
• hives, itching, or skin rash
• hoarseness
• irregular, slow, or shallow breathing
• irritability
• irritation
• joint pain, stiffness, or swelling
• numbness of the feet, hands, and around the mouth
• 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
• seeing, hearing, or feeling things that are not there
• severe constipation
• severe vomiting
• stomach pain
• shaking
• trouble in holding or releasing urine
• unusual drowsiness, dullness, or feeling of sluggishness

Incidence not known

• Agitation
• darkening of the skin
• diarrhea
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of appetite
• mental depression
• nausea
• overactive reflexes
• poor coordination
• seizures
• shivering
• talking or acting with excitement you cannot control
• twitching
• vomiting

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

Symptoms of overdose

• Change in consciousness
• cold and clammy skin
• constricted, pinpoint, or small pupils (black part of the eye)
• decreased awareness or responsiveness
• difficult or trouble breathing
• irregular, fast, slow, or shallow breathing
• loss of consciousness
• low blood pressure or pulse
• muscle weakness
• pale or blue lips, fingernails, or skin
• severe sleepiness or unusual drowsiness

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
• feeling of constant movement of self or surroundings
• relaxed and calm
• sensation of spinning
• sleepiness

Less common

• Belching
• decreased weight
• discouragement
• excess air or gas in the stomach or bowels
• 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 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
• night blindness
• nightmares or unusually vivid dreams
• overbright appearance of lights
• sudden sweating
• tunnel vision
• welts

Incidence not known

• Forgetfulness
• loss of memory
• problems with memory

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.

In the U.S.

• Opana
• Opana ER

Available Dosage Forms:

• Tablet, Extended Release
• Tablet

Therapeutic Class: Analgesic

Chemical Class: Opioid

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 very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxymorphone. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

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:

• Swallow the extended-release tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing it 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.

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® tablet 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 given in 2 divided 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 moderate to severe pain: For patients who are not taking narcotic medicines: Adults—At first, 10 to 20 milligrams (mg) every 4 to 6 hours per day. Your doctor may adjust your dose as needed. Children—Use is not recommended. For patients switching from oxymorphone injection to Opana®: Adults—At first, the dose is 10 times the total oxymorphone injection dose that you are receiving per day, divided into 4 to 6 equal doses. Your doctor may adjust your dose as needed. Children—Use is not recommended. For patients switching from oral opioids to Opana®: Adults—At first, the dose is half of the total daily dose that you are taking per day, divided into 4 to 6 equal doses, every 4 to 6 hours. Your doctor may adjust your dose as needed. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, 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.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

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