Description and Brand Names

Drug information provided by: Micromedex

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

Descriptions


Oxycodone and acetaminophen combination is used to relieve moderate to moderately severe pain.

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.

Oxycodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

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 with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet
  • Solution
  • Tablet, Extended Release
  • Capsule

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. 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 solution and tablets in the elderly. However, elderly patients are more likely to have age-related kidney 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 capsules in the pediatric population. Safety and efficacy have not been established.

Pregnancy

Information about this oxycodone-and-acetaminophen-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

  • Naltrexone

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
  • Acetophenazine
  • Alfentanil
  • Alprazolam
  • Amiodarone
  • Amobarbital
  • Amprenavir
  • Anileridine
  • Aprepitant
  • Atazanavir
  • Brofaromine
  • Bromazepam
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Ceritinib
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clorgyline
  • Cobicistat
  • Codeine
  • Crizotinib
  • Dabrafenib
  • Dantrolene
  • Darunavir
  • Dexmedetomidine
  • Dezocine
  • Diazepam
  • Diphenhydramine
  • Dixyrazine
  • Doxylamine
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Etomidate
  • Fentanyl
  • Flumazenil
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fluvoxamine
  • Fosaprepitant
  • Fospropofol
  • Furazolidone
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Imatinib
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Itraconazole
  • Ketamine
  • Ketazolam
  • Ketoconazole
  • Lazabemide
  • Levorphanol
  • Linezolid
  • Loprazolam
  • Lorazepam
  • Lormetazepam
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Metopimazine
  • Midazolam
  • Mitotane
  • Moclobemide
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nefazodone
  • Nelfinavir
  • Nialamide
  • Nitrazepam
  • Opium
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pargyline
  • Pentazocine
  • Pentobarbital
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Piperaquine
  • Pipotiazine
  • Pixantrone
  • Prazepam
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propiomazine
  • Propofol
  • Propoxyphene
  • Quazepam
  • Ramelteon
  • Rasagiline
  • Remifentanil
  • Ritonavir
  • Saquinavir
  • Secobarbital
  • Selegiline
  • Sertraline
  • Siltuximab
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Telithromycin
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioproperazine
  • Thioridazine
  • Toloxatone
  • Tranylcypromine
  • Triazolam
  • Trifluoperazine
  • Triflupromazine
  • Trimeprazine
  • Zaleplon
  • Zolpidem

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
  • Carbamazepine
  • Fosphenytoin
  • Isoniazid
  • Lixisenatide
  • Miconazole
  • Perampanel
  • Phenytoin
  • Rifampin
  • St John's Wort
  • Voriconazole
  • 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
  • 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 abuse, history of or
  • Breathing or lung problems (eg, asthma, chronic obstructive pulmonary disease [COPD], cor pulmonale) or
  • CNS depression or
  • Drug dependence, especially with narcotic abuse or dependence, or history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Hypothyroidism (an underactive thyroid) or
  • Hypovolemia (low blood volume) or
  • Kyphoscoliosis (curvature of the spine with breathing problems) or
  • Mental illness or
  • Problems with passing urine or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Asthma, severe or
  • Hypercarbia (high carbon dioxide in the blood), severe or
  • Paralytic ileus (bowels stop working and may be blocked) or
  • Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.
  • Brain tumor, history of or
  • Head injuries, history of or
  • Increased pressure in the head—Some of the side effects of oxycodone can cause serious problems in people who have these medical problems.
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation 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.
  • Stomach or digestion problems—This medicine may mask the diagnosis of these conditions.

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.

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

You may take this medicine with or without food.

Measure the oral liquid using the patient cup that comes with the package.

Swallow the extended-release tablet whole with water. Do not crush, break, chew, or dissolve 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).

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. The second dose may be given as early as 8 hours after your first dose, and the following doses are given every 12 hours.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (solution):
      • Adults—5 milliliters (mL) or one teaspoonful every 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—1 tablet every 6 hours as 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Flush any unused capsules, liquid, or tablets down the toilet.

Precautions

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

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. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and 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.

Do not use Xartermis™ XR if you have used an MAO inhibitor in the past 14 days. Using these medicine together may cause serious unwanted effects.

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. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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.

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, irritability, nausea, restlessness, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects 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.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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.

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

Rare

  1. Cough or hoarseness
  2. fever with or without chills
  3. general feeling of tiredness or weakness
  4. lower back or side pain
  5. painful or difficult urination
  6. sore throat
  7. sores, ulcers, or white spots on the lips or in the mouth
  8. 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 or discomfort
  9. clay-colored stools
  10. cloudy urine
  11. clumsiness
  12. confusion
  13. constipation
  14. coughing that sometimes produces a pink frothy sputum
  15. decrease in the frequency of urination
  16. decrease in urine volume
  17. decreased awareness or responsiveness
  18. decreased frequency or amount of urine
  19. decreased urination
  20. difficult or labored breathing
  21. difficult or painful urination
  22. difficult, fast, noisy breathing, sometimes with wheezing
  23. difficulty in passing urine (dribbling)
  24. difficulty with swallowing
  25. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  26. drowsiness
  27. dry mouth
  28. extremely shallow or slow breathing
  29. fainting
  30. fast or deep breathing
  31. fast, slow, irregular, pounding, or racing heartbeat or pulse
  32. feeling of warmth
  33. general body swelling
  34. greatly decreased frequency of urination or amount of urine
  35. increased sweating
  36. increased thirst
  37. indigestion
  38. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  39. lightheadedness
  40. muscle aches
  41. muscle tremors
  42. muscle weakness
  43. nervousness
  44. noisy breathing
  45. nosebleeds
  46. numbness or tingling in the hands, feet, or lips
  47. pains in the stomach, side, or abdomen, possibly radiating to the back
  48. pale skin
  49. pinpoint red spots on the skin
  50. pounding in the ears
  51. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  52. rapid, deep breathing
  53. rapid, shallow breathing
  54. redness of the face, neck, arms, and occasionally, upper chest
  55. redness of the skin
  56. restlessness
  57. seizures
  58. severe constipation
  59. severe sleepiness
  60. severe vomiting
  61. shivering
  62. skin blisters
  63. skin rash, hives, or welts
  64. sleepiness
  65. slow or irregular breathing
  66. sore throat
  67. stomach cramps
  68. stomach pain, continuing
  69. sudden decrease in the amount of urine
  70. sunken eyes
  71. sweating
  72. swelling in the legs and ankles
  73. swelling of the face, fingers, or lower legs
  74. thirst
  75. tightness in the chest
  76. tiredness
  77. troubled breathing
  78. unpleasant breath odor
  79. upper right abdominal or stomach pain
  80. vomiting
  81. weak or feeble pulse
  82. weakness or heaviness of the legs
  83. weight gain
  84. wrinkled skin

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. no blood pressure or pulse
  8. not breathing
  9. stopping of heart
  10. 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

Incidence not known

  1. Acid or sour stomach
  2. agitation
  3. bad or unusual or unpleasant (after) taste
  4. belching
  5. change in taste
  6. cold sweats
  7. constricted, pinpoint, or small pupils (black part of the eye)
  8. continuing ringing or buzzing or other unexplained noise in the ears
  9. cool, pale skin
  10. depression
  11. diarrhea
  12. difficulty with moving
  13. disturbed color perception
  14. double vision
  15. excess air or gas in the stomach or intestines
  16. false or unusual sense of well-being
  17. flushed, dry skin
  18. fruit-like breath odor
  19. full feeling
  20. general feeling of discomfort or illness
  21. halos around lights
  22. hearing loss
  23. heartburn
  24. increased hunger
  25. increased thirst
  26. increased urination
  27. indigestion
  28. joint pain
  29. lack or loss of strength
  30. muscle cramps or spasms
  31. muscle pain or stiffness
  32. night blindness
  33. nightmares
  34. overbright appearance of lights
  35. passing gas
  36. red eye
  37. seeing, hearing, or feeling things that are not there
  38. seizures
  39. shakiness
  40. sleepiness or unusual drowsiness
  41. slurred speech
  42. stomach discomfort, upset, or pain
  43. stomach fullness
  44. sweating
  45. swollen joints
  46. thirst
  47. trouble sleeping
  48. tunnel vision
  49. unexplained weight loss
  50. 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.