Before Using

Drug information provided by: Merative, Micromedex®

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 acetaminophen combination in the pediatric population. Use of Xartemis™ is not recommended in children. 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 acetaminophen combination extended-release tablet, solution, or tablet in the elderly. However, elderly patients are more likely to have age-related kidney, heart, lung, or liver problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone and acetaminophen combination capsules in the pediatric population. Safety and efficacy have not been established.

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.

  • 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
  • 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
  • Enasidenib
  • Enflurane
  • Enzalutamide
  • 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
  • Isoniazid
  • 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
  • Nalorphine
  • Naloxone
  • Naratriptan
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nevirapine
  • Nialamide
  • Nicomorphine
  • Nilotinib
  • Nirogacestat
  • 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
  • Pixantrone
  • Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
  • 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
  • Repotrectinib
  • 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
  • Vonoprazan
  • 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.

  • Acenocoumarol
  • Fosphenytoin
  • Lixisenatide
  • Phenytoin
  • St John's Wort
  • Warfarin
  • Zidovudine

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
  • Grapefruit Juice
  • Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects 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.

  • Cabbage

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 abuse, history of or
  • Brain tumor, history of or
  • Breathing or lung problems (eg, low oxygen levels, sleep apnea) or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart problem) or
  • Drug dependence, especially with narcotic abuse or dependence, or history of or
  • Gallbladder disease or
  • Head injury, history of or
  • Hypothyroidism (an underactive thyroid) or
  • Hypovolemia (low blood volume) or
  • Kyphoscoliosis (curvature of the spine with breathing problems) or
  • Mental health problems or
  • Problems with passing urine or
  • Prostatic hypertrophy (enlarged prostate, BPH) or
  • Trouble swallowing or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Asthma, acute or severe or
  • Lung disease or breathing problems (eg, asthma, respiratory depression), severe 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—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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