Oxymorphone (Oral)

Generic name: Oxymorphone
Drug class: Opioids (narcotic analgesics)

Usage of Oxymorphone (Oral)

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.

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 where a 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 under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

Oxymorphone (Oral) 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

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 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.

Before taking Oxymorphone (Oral)

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.

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.

Nalmefene

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

Alfentanil

Almotriptan

Alprazolam

Alvimopan

Amifampridine

Amineptine

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphetamine

Anileridine

Aripiprazole

Asenapine

Baclofen

Benperidol

Benzhydrocodone

Benzphetamine

Bromazepam

Bromopride

Butorphanol

Calcium Oxybate

Cannabis

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 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

Relate drugs

How to use Oxymorphone (Oral)

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

Warnings

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.

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.

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 cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

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 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.

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.

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).

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.

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.

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Oxymorphone (Oral)

Usage of Oxymorphone (Oral)

Oxymorphone (Oral) side effects

Before taking Oxymorphone (Oral)

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Relate drugs

How to use Oxymorphone (Oral)

Dosing

Missed Dose

Storage

Warnings

Disclaimer

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