Description
Oxymorphone is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. Oxymorphone 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 its 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.
This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
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, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving oxymorphone.
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
- Safinamide
- Samidorphan
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
- Aclidinium
- Alfentanil
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Anileridine
- Aripiprazole
- Aripiprazole Lauroxil
- Asenapine
- Atropine
- Baclofen
- Belladonna
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
- Benzthiazide
- Benztropine
- Biperiden
- Bromazepam
- Bromopride
- Brompheniramine
- Bumetanide
- Buprenorphine
- Bupropion
- Buspirone
- Butabarbital
- Butalbital
- Butorphanol
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 disease (adrenal gland problem) or
- Alcohol use disorder, or history of or
- Brain tumor or
- Breathing or lung problems (eg, COPD, hypoxia, sleep apnea) or
- Cor pulmonale (serious heart condition) or
- Depression, history of or
- Drug dependence, especially narcotic use disorder 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 serious 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, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Liver disease, moderate to severe or
- Lung or breathing problems (eg, asthma, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
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 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 patients who are not taking narcotic medicines:
- For moderate to severe pain:
- 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.
- For patients who are not taking narcotic medicines:
- For moderate to severe pain:
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
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may needed to check for unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
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 cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea while using this medicine.
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 an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
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 adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
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.
Oxymorphone may increase your risk of having serious breathing problems. Check with your doctor right away if you are having difficult or trouble breathing, irregular, fast, slow, or shallow breathing, or pale or blue lips, fingernails, or skin.
Using too much oxymorphone may cause an overdose, which can be life-threatening. Symptoms of an overdose include : change 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 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. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
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, or to take another narcotic for a while, to lessen the chance of withdrawal side effects (eg, anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping).
For nursing mothers taking this medicine:
- Talk to your doctor if you have any questions about taking oxymorphone or about 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 (eg, "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 need immediate medical attention.
Using too much of this medicine may cause 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 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
- Blurred vision
- chest tightness
- 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
- 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
- increased sensitivity to pain
- 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
- worsening of pain
Get emergency help immediately if any of the following symptoms of overdose occur:
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.
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