Oxycodone and naloxone

Generic name: Oxycodone And Naloxone
Drug class: Narcotic analgesic combinations

Usage of Oxycodone and naloxone

Oxycodone and naloxone combination is used to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and when other pain medicines did not work well enough or cannot be tolerated.

Oxycodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain. Naloxone is used to treat an opioid emergency such as an overdose or a possible overdose of a narcotic medicine.

Oxycodone and naloxone combination should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain, or in situations when non-narcotic medication is effective. This medicine should not be used to treat pain that you only have once in a while or "as needed".

When oxycodone 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 gradually reducing the dose 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.

Oxycodone and naloxone 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:

Incidence not known

  • Agitation
  • blurred vision
  • confusion
  • cough
  • darkening of the skin
  • diarrhea
  • difficult or troubled breathing
  • difficulty swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast heartbeat
  • fever
  • hives, itching, skin rash
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • mental depression
  • nausea
  • 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
  • tightness in the chest
  • trembling or shaking
  • twitching
  • unusual tiredness or weakness
  • vomiting
  • Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

  • Bigger, dilated, or enlarged pupils (black part of the eye)
  • change in consciousness
  • chest pain or discomfort
  • cold, clammy skin
  • coughing that sometimes produces a pink frothy sputum
  • decreased awareness or responsiveness
  • difficult, fast, noisy breathing
  • increased sensitivity of the eyes to light
  • increased sweating
  • loss of consciousness
  • severe sleepiness
  • sleepiness or unusual drowsiness
  • slow or irregular heartbeat
  • swelling in the legs and ankles
  • 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:

    Less common

  • Back pain
  • difficulty having a bowel movement
  • difficulty with moving
  • fear or nervousness
  • feeling of warmth
  • headache
  • muscle pain or stiffness
  • pain in the joints
  • redness of the face, neck, arms, and occasionally, upper chest
  • stomach pain
  • sudden sweating
  • trouble sleeping
  • 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 Oxycodone and naloxone

    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 oxycodone and naloxone combination 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 oxycodone and naloxone combination in the elderly. However, 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 oxycodone and naloxone combination.

    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.

  • Levoketoconazole
  • 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.

  • 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
  • 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
  • Oxycodone
  • 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 medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clonidine
  • St John's Wort
  • Yohimbine
  • 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
  • Grapefruit Juice
  • 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:

  • Adrenal problems or
  • Alcohol abuse, or history of or
  • Brain tumor, history of or
  • Breathing problems (eg, hypoxia) or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Depression or
  • Drug dependence, especially with narcotics, or history of or
  • Gallbladder disease or gallstones or
  • Head injuries, history of or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Asthma, acute or severe or
  • Liver disease, moderate to severe or
  • Respiratory depression (very slow breathing) or
  • Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.
  • Hypotension (low blood pressure) 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.
  • Relate drugs

    How to use Oxycodone and naloxone

    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).

    It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone. 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.

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

    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:
  • Patients who are not taking narcotic medicines:
  • Adults—At first, 10 milligrams (mg) of oxycodone and 5 mg of naloxone every 12 hours. Your doctor may adjust your dose as needed.
  • Children—Use and dose must be determined by your doctor.
  • Patients who are taking regular oxycodone:
  • Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day is half of the total amount of regular oxycodone that is taken per day. The total amount per day will be given as 2 divided doses during the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg of oxycodone and 40 mg of naloxone per day.
  • Children—Use and dose must be determined by your doctor.
  • Patients switching from other narcotic medicines:
  • Adults—The tablet 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 given as 2 divided doses during the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg of oxycodone and 40 mg of naloxone per day.
  • Children—Use and dose must be determined by your doctor.
  • 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.

    Oxycodone 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 while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

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

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

    Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

    This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for 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 these medicines 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.

    Dizziness, lightheadedness, or 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 the dizziness or lightheadedness.

    This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    Using narcotics 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.

    If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

    Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

    For nursing mothers taking Belbuca®:

  • Talk to your doctor if you have any questions about taking oxycodone and naloxone combination 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 for more than 4 hours at a time.
  • Check with your doctor or hospital emergency room 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.
  • 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 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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    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

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