Description and Brand Names

US Brand Name

1. Endocet
2. Magnacet
3. Narvox
4. Percocet
5. Perloxx
6. Primalev
7. Roxicet
8. Roxilox
9. Tylox
10. Xartemix XR
11. Xolox

Canadian Brand Name

1. oxyCODONEACET
2. Rivacocet
3. Teva-Oxycocet

Descriptions

Oxycodone and acetaminophen combination 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.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

Oxycodone belongs to the group of medicines called opioid analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain, and stops or prevents cough.

When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, under the close supervision of healthcare providers, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor’s prescription. Percocet® and Xartemis™ are 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
• Solution

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 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 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
• Mavorixafor
• 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
• Alfentanil
• Almotriptan
• Alosetron
• Alprazolam
• 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
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Celecoxib
• Cenobamate
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Cilostazol
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clofazimine
• 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
• Dicloxacillin
• Dicyclomine
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Dipyrone
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Duvelisib
• 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
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Homatropine
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Hyoscyamine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Ipratropium
• Isocarboxazid
• Isoflurane
• Isoniazid
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lanreotide
• Larotrectinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Lesinurad
• Letermovir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lonafarnib
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Maribavir
• Mavacamten
• Meclizine
• Medazepam
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaclazepam
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Methylprednisolone
• Metoclopramide
• Midazolam
• Mifepristone
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Mobocertinib
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nicomorphine
• Nilotinib
• Nirogacestat
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Nortriptyline
• Octreotide
• Olanzapine
• Oliceridine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paritaprevir
• 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
• Schisandra sphenanthera
• Scopolamine
• Secobarbital
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Solifenacin
• Sotorasib
• St John’s Wort
• Stramonium
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Taurursodiol
• Telaprevir
• Telithromycin
• Telotristat Ethyl
• Temazepam
• Terbinafine
• Terodiline
• Tetrazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Ticagrelor
• Tilidine
• Tiotropium
• Tizanidine
• Tocilizumab
• Tolonium Chloride
• Tolterodine
• Topiramate
• Tovorafenib
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Trofinetide
• Troleandomycin
• 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
• 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’s disease (adrenal gland problem) or
• Alcohol use disorder, history of or
• Brain tumor, history of or
• Breathing or lung problems (eg, COPD, low oxygen levels, sleep apnea) or
• Cor pulmonale (serious heart problem) or
• Drug use disorder or dependence, or history of or
• Gallbladder disease or
• Head injury, history of or
• Hypothyroidism (an underactive thyroid) or
• Hypovolemia (low blood volume) or
• Increased pressure in the head 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.

Proper Use

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 and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

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

You may take this medicine with or without food.

Swallow the extended-release tablet whole with water. Do not crush, break, chew, dissolve, snort, or inject it. Do not pre-soak, lick, or wet the tablet before placing it in your mouth. Do not give this medicine by feeding tubes.

Check with your doctor first before changing dosage forms (eg, capsules, extended-release tablets, tablets). These forms are very different from each other.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours). Patients with liver disease may have a lower daily maximum dose of acetaminophen.

Close follow-up with healthcare providers and creation of a pain management plan is an effective way to manage chronic pain. This plan may include limiting opioid medicines to the lowest effective dose for a limited period of time. The plan may also include non-medicine treatments such as relaxation techniques, massage therapy, or transcutaneous electrical stimulation (TENS).

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 moderate to moderately severe pain:
  • For oral dosage form (capsules):
    • Adults—1 capsule every 6 hours as needed.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • Adults—2 tablets every 12 hours as needed.
    • Children—Use is not recommended.
  • For oral dosage form (oxycodone and acetaminophen tablets):
    • Adults—1 tablet (7.5 milligrams (mg) of oxycodone and 325 mg of acetaminophen) every 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 tablets per day.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (Endocet® tablets):
    • Adults—1 or 2 tablets every 6 hours as needed.
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (Percocet® tablets):
    • Adults—1 or 2 tablets every 6 hours as needed.
      • Percocet® 2.5 mg/325 mg tablets (2.5 milligrams (mg) of oxycodone and 325 mg of acetaminophen): 1 or 2 tablets every 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 12 tablets per day.
      • Percocet® 5 mg/325 mg tablets (5 mg of oxycodone and 325 mg of acetaminophen): 1 tablet every 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 12 tablets per day.
      • Percocet® 7.5 mg/325 mg tablets (7.5 mg of oxycodone and 325 mg of acetaminophen): 1 tablet every 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 tablets per day.
      • Percocet® 10 mg/325 mg tablets (10 mg of oxycodone and 325 mg of acetaminophen) 1 tablet every 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 tablets per day.
    • 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.

If you miss a dose of Percocet®, skip the missed dose and go back to your regular dosing schedule.

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 and acetaminophen combination can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong opioid pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid 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

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:

More common

1. Black, tarry stools
2. chills
3. dark urine
4. dizziness
5. fever
6. headache
7. itching, skin rash
8. light-colored stools
9. loss of appetite
10. nausea
11. stomach pain
12. unpleasant breath odor
13. unusual tiredness or weakness
14. vomiting of blood
15. yellow eyes or skin

Rare

1. Cough
2. fever with or without chills
3. general feeling of tiredness or weakness
4. hoarseness
5. lower back or side pain
6. painful or difficult urination
7. sore throat
8. sores, ulcers, or white spots on the lips or in the mouth
9. unusual bleeding or bruising

Incidence not known

1. Back, leg, or stomach pains
2. bleeding gums
3. bloating
4. blood in the urine or stools
5. blue lips and fingernails
6. blurred vision
7. burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
8. chest pain, discomfort, or tightness
9. cloudy urine
10. clumsiness
11. confusion
12. constipation
13. coughing that sometimes produces a pink frothy sputum
14. darkening of the skin
15. decreased awareness or responsiveness
16. decreased frequency or amount of urine
17. diarrhea
18. difficult, fast, noisy breathing
19. difficulty in passing urine (dribbling)
20. difficulty with swallowing
21. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
22. drowsiness
23. dry mouth
24. extremely shallow or slow breathing
25. fainting
26. fast or deep breathing
27. fast, slow, irregular, pounding, or racing heartbeat
28. feeling of warmth
29. general body swelling
30. hives or welts
31. increased sweating
32. increased thirst
33. indigestion
34. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
35. lightheadedness
36. mental depression
37. muscle aches, tremors, or weakness
38. nervousness
39. nosebleeds
40. pains in the stomach, side, or abdomen, possibly radiating to the back
41. pale skin
42. pinpoint red spots on the skin
43. pounding in the ears
44. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
45. rapid, deep or shallow breathing
46. redness of the face, neck, arms, and occasionally, upper chest
47. restlessness
48. seizures
49. severe constipation
50. severe sleepiness
51. severe vomiting
52. skin blisters
53. sleepiness
54. stomach cramps
55. sunken eyes
56. sweating
57. swelling of the face, fingers, lower legs, or ankles
58. thirst
59. tiredness
60. trouble breathing
61. vomiting
62. weakness or heaviness of the legs
63. weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

1. Bluish lips or skin
2. change in consciousness
3. cold, clammy skin
4. extreme sleepiness
5. general feeling of discomfort or illness
6. loss of consciousness
7. low blood pressure or pulse
8. slow breathing
9. unconsciousness

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

1. Relaxed and calm feeling

Incidence not known

1. Agitation
2. bad, unusual or unpleasant (after) taste
3. belching
4. change in taste
5. cold sweats
6. constricted, pinpoint, or small pupils (black part of the eye)
7. continuing ringing or buzzing or other unexplained noise in the ears
8. cool, pale skin
9. depression
10. difficulty with moving
11. disturbed color perception
12. double vision
13. excess air or gas in the stomach or bowels
14. false or unusual sense of well-being
15. flushed, dry skin
16. fruit-like breath odor
17. full feeling
18. general feeling of discomfort or illness
19. halos around lights
20. hearing loss
21. heartburn
22. increased hunger
23. increased urination
24. indigestion
25. joint pain
26. lack or loss of strength
27. muscle cramps, spasms, pain, or stiffness
28. night blindness
29. nightmares
30. overbright appearance of lights
31. seeing, hearing, or feeling things that are not there
32. seizures
33. shakiness
34. slurred speech
35. swollen joints
36. trouble sleeping
37. tunnel vision
38. unexplained weight loss
39. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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