Oxycodone and naltrexone (Oral)

Oxycodone and naltrexone combination is used to relieve severe pain. It is part of a group of medicines called narcotic analgesics (pain medicines). Oxycodone works on the central nervous system (CNS) to relieve pain.

Oxycodone and naltrexone combination should not be used if you need pain medicine for only a short time, such as after surgery. Do not use this medicine to relieve mild pain or when non-narcotic medication is effective. This medicine should not be used to treat pain that occurs only occasionally or "as needed."

When oxycodone is used for a long time, it may become habit-forming, leading to mental or physical dependence. However, people who have ongoing pain should not let the fear of dependence stop them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to happen when narcotics are used for this purpose. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually reducing the dose over time before stopping treatment completely.

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

It is very important for your doctor to monitor your progress while you are taking this medicine. This will help your doctor determine if the medicine is effective and whether you should keep taking it.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Call your doctor right away if you experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while taking this medicine.

Do not use more of this medicine or take it more often than your doctor instructs. 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 immediately if you notice these symptoms.

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 are antihistamines or medicines for allergies or colds, sedatives, tranquilizers, or 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 medicines while using this medicine.

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

Dizziness, lightheadedness, or fainting may happen when you get up suddenly from lying or sitting down. Getting up slowly may help reduce this issue. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may cause you to feel dizzy, drowsy, or lightheaded. Make sure you know how this medicine affects you before you drive, operate machinery, or do anything else that could be dangerous if you are not alert.

Using narcotics 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. Be sure to follow these instructions carefully, as ongoing constipation can lead to more serious issues.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without consulting your doctor. Your doctor may want you to gradually reduce the amount you use before stopping completely. This may help prevent worsening of your condition and reduce the chance of withdrawal symptoms, such as chills, runny nose, muscle pain, sweating, restlessness, or yawning.

Using this medicine during pregnancy may cause serious unwanted effects in your newborn baby. Inform your doctor immediately if you think you are pregnant or plan to become pregnant while using this medicine.

Talk to your doctor before using this medicine if you plan to have children. Some men and women who take this medicine have become infertile (unable to have children).

Make sure your doctor is aware of all other medicines you are taking. This medicine may cause a serious condition called serotonin syndrome when taken with certain medicines such as linezolid, mirtazapine, trazodone, MAO inhibitors, and some pain medicines (e.g., tramadol (Ultram®), sumatriptan (Imitrex®), zolmitriptan (Zomig®), or rizatriptan (Maxalt®). Check with your doctor before taking any other medicines.

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

In deciding to use a medicine, the chances of taking the medication must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medicine, 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 medications. 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 Troxyca® ER 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 Troxyca® ER in the elderly. Nevertheless, elderly patients are more likely to have age-related lung, liver, or kidney problems, which may require caution and an adjustment in the dose for patients receiving Troxyca® ER in order to avoid potentially serious side effects.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this drug.

Interactions with Medicines

Although certain medications should not be used together at all, in other cases two different medications 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 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 advised. Your doctor may decide not to treat you with this drug or change some of the other medications you take.

• Alfentanil
• Alphaprodine
• Anileridine
• Benzhydrocodone
• Buprenorphine
• Butorphanol
• Codeine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Ethylmorphine
• Fentanyl
• Hydrocodone
• Hydromorphone
• Ketobemidone
• Levoketoconazole
• Levorphanol
• Meperidine
• Methadone
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nalmefene
• Naltrexone
• Nicomorphine
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Piritramide
• Propoxyphene
• Remifentanil
• Safinamide
• Samidorphan
• Sufentanil
• Tapentadol
• Tilidine
• Tramadol

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

• Abiraterone Acetate
• Acepromazine
• Aclidinium
• Adagrasib
• Alfentanil
• Almotriptan
• Alosetron
• Alprazolam
• Alvimopan
• Amantadine
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Apalutamide
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Asciminib
• Asenapine
• Atazanavir
• Atropine
• Avacopan
• Baclofen
• Belladonna
• Belzutifan
• Benperidol
• Bentazepam
• Benzhydrocodone
• Benzphetamine
• Benztropine
• Berotralstat
• Biperiden
• Boceprevir
• Bosentan
• Bremelanotide
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cenobamate
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Cloxazolam
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclopentolate
• Cyclosporine
• Cyproheptadine
• Dabrafenib
• Dantrolene
• Daridorexant
• Darifenacin
• Darunavir
• Delavirdine
• Delorazepam
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diacetylmorphine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Dicyclomine
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Elagolix
• Eletriptan
• Enflurane
• Enzalutamide
• Erdafitinib
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Flavoxate
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Homatropine
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Hyoscyamine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Ipratropium
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lanreotide
• Larotrectinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Letermovir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Medazepam
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaclazepam
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Methylnaltrexone
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Mobocertinib
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naldemedine
• Nalorphine
• Naloxegol
• Naloxone
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Nortriptyline
• Octreotide
• Olanzapine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimozide
• Pinazepam
• Pipenzolate Bromide
• Piperacetazine
• Pipotiazine
• Pirenzepine
• Piritramide
• Pirtobrutinib
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Procyclidine
• Promazine
• Promethazine
• Propantheline
• Propiverine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Rizatriptan
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Solifenacin
• Sotorasib
• Stramonium
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Taurursodiol
• Telaprevir
• Telithromycin
• Temazepam
• Terbinafine
• Terodiline
• Tetrazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tocilizumab
• Tolonium Chloride
• Tolterodine
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Trofinetide
• Tropicamide
• Trospium
• Tryptophan
• Tucatinib
• Umeclidinium
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Voxelotor
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

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

• Lofexidine
• St John's Wort
• Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medications 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 drugs may as well 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 doctor may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other Medical Problems

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

• Addison disease (adrenal gland issue) or
• Alcohol abuse, or history of or
• Brain tumor, history of or
• Breathing issues (eg, hypoxia) or
• Central nervous system (CNS) depression or
• Chronic obstructive pulmonary disease (COPD) or
• Drug dependence, especially with narcotics, or history of or
• Gallbladder disease or gallstones or
• Head injuries, history of or
• Psychosis (a mental disease)—Use with caution. May raise chance for more severe side effects.

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

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

Along with its helpful effects, this medicine may cause some unwanted effects. Not all side effects will happen, but if they do, you may need medical help.

Contact your doctor right away if you notice any of the following side effects:

Less common

• Fast, pounding, or irregular heartbeat or pulse
• Fever
• Hives, itching, or rash
• Hoarseness
• Irritation
• Joint pain, stiffness, or swelling
• Pale skin
• Redness of the skin
• Swelling of the eyelids, face, lips, hands, or feet
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Tightness in the chest
• Trouble breathing or swallowing
• Trouble breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Incidence not known

• Abdominal or stomach pain
• Agitation
• Blurred vision
• Confusion
• Cough
• Diarrhea
• Dizziness or fainting
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Headache
• Irregular, fast or slow, or shallow breathing
• Loss of appetite
• Nausea with or without vomiting
• Overactive reflexes
• Pale or blue lips, fingernails, or skin
• Poor coordination
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Restlessness
• Seizures
• Shivering
• Sweating
• Talking or acting with excitement you cannot control
• Trembling or shaking
• Twitching

Some side effects may occur that usually do not need medical attention. These side effects may go away as your body gets used to the medicine. Your healthcare professional might be able to suggest ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Back pain
• Difficulty having a bowel movement (stool)
• Sleepiness or unusual drowsiness
• Trouble sleeping

Less common

• Acid or sour stomach
• Belching
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Decreased appetite
• Difficulty with moving
• Dry mouth
• Feeling of warmth
• Heartburn
• Indigestion
• Muscle pain or stiffness
• Muscle spasms
• Pain in the joints
• Rapid weight gain
• Redness of the face, neck, arms, and occasionally, upper chest
• Stomach discomfort or upset
• Sudden sweating
• Tingling of the hands or feet
• Unusual weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, talk to 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.

• Troxyca ER

Pharmacologic Class: Naltrexone

Chemical Class: Oxycodone

Take this medicine only 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).

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release capsule whole. Do not dissolve, crush, break, or chew it.

If you have trouble swallowing the capsule, you may open it and pour the medicine into a small amount of applesauce. This mixture must be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets. Do not give this medicine in a nasogastric or gastric tube.

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 capsules):For severe pain: Patients who are not taking narcotic medicines or are not opioid tolerant: Adults—At first, 1 capsule (10 milligrams (mg) of oxycodone and 1.2 mg of naltrexone) every 12 hours. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor. Patients switching from regular oxycodone forms: Adults—The capsule is given every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular oxycodone that is taken per day. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor. Patients switching from other narcotic medicines: Adults—The capsule is given every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. The total amount per day will be divided and given as 2 doses during the day. 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.

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

This medicine 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.