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Xartemis XR extended-release tablets

Generic Name: oxycodone/acetaminophen (OX-i-KOE-done/a-SEET-a-MIN-oh-fen)
Brand Name: Xartemis XR

Xartemis XR extended-release tablets is a narcotic pain medicine that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.

Xartemis XR extended-release tablets may cause severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or whenever the dose is increased. Contact your doctor right away if you experience slow, shallow, or difficult breathing.

Be sure to swallow Xartemis XR extended-release tablets whole. Do NOT break, crush, cut, dissolve, or chew Xartemis XR extended-release tablets before swallowing it. Do NOT inject Xartemis XR extended-release tablets. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose.

Accidental swallowing of Xartemis XR extended-release tablets may be fatal, especially in children. Keep Xartemis XR extended-release tablets out of the reach of children. Seek emergency medical care right away if another person swallows Xartemis XR extended-release tablets.

Long-term use of Xartemis XR extended-release tablets during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.

Xartemis XR extended-release tablets contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.


Xartemis XR extended-release tablets is used for:

Managing certain types of short-term pain.

Xartemis XR extended-release tablets is a combination of a narcotic and an analgesic/antipyretic. It works in the brain and nervous system to decrease pain.

Do NOT use Xartemis XR extended-release tablets if:

  • you are allergic to any ingredient in Xartemis XR extended-release tablets
  • you have high blood carbon dioxide levels (hypercarbia), a certain severe bowel problem (paralytic ileus), or narrowing of the stomach or bowels
  • you have severely slow or difficult breathing or severe asthma, or you are having an asthma attack
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Before using Xartemis XR extended-release tablets:

Some medical conditions may interact with Xartemis XR extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had an allergic reaction to any codeine- or morphine-related medicine (eg, hydrocodone, dihydrocodeine, hydromorphone)
  • if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of the spine (scoliosis), a certain heart problem (cor pulmonale), high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or low levels of oxygen in the blood (hypoxia)
  • if you have severe drowsiness, a recent head injury, increased pressure in the brain, growths in the brain (eg, tumors, lesions), or a history of seizures
  • if you have a history of liver problems, kidney problems, thyroid problems, gallbladder problems, pancreas problems (eg, pancreatitis), urinary blockage or trouble urinating, an enlarged prostate, or stomach or bowel problems (eg, blockage, esophageal or colon cancer, inflammation)
  • if you have difficulty swallowing, constipation, low blood pressure, dehydration, low blood volume, poor health, or stomach pain
  • if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you or a member of your family has a history of mood or mental problems (eg, depression) or alcohol or other substance abuse or dependence
  • if you are very overweight or have recently had or will be having surgery (eg, stomach or bowel surgery)

Some MEDICINES MAY INTERACT with Xartemis XR extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticholinergics (eg, scopolamine, oxybutynin) because the risk of constipation and trouble urinating may be increased
  • Azole antifungals (eg, itraconazole, ketoconazole), macrolide antibiotics (eg, clarithromycin, erythromycin), MAOIs (eg, phenelzine), nefazodone, other narcotic pain medicines (eg, codeine, morphine), phenothiazines (eg, chlorpromazine), or protease inhibitors (eg, boceprevir, ritonavir) because they may increase the risk of Xartemis XR extended-release tablets's side effects
  • Carbamazepine, phenytoin, or rifampin because they may decrease Xartemis XR extended-release tablets's effectiveness
  • Mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or naltrexone because they may decrease Xartemis XR extended-release tablets's effectiveness and withdrawal may occur
  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xartemis XR extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xartemis XR extended-release tablets:

Use Xartemis XR extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Xartemis XR extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Xartemis XR extended-release tablets refilled.
  • Take Xartemis XR extended-release tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Xartemis XR extended-release tablets must only be taken by mouth. Do not inject Xartemis XR extended-release tablets.
  • Swallow Xartemis XR extended-release tablets whole. Do not break, cut, crush, chew, or dissolve the tablet before swallowing it. If you cannot swallow Xartemis XR extended-release tablets whole, tell your doctor.
  • Take Xartemis XR extended-release tablets 1 tablet at a time if your dose calls for more than 1 tablet. Do not presoak, lick, or wet the tablet before you place it in your mouth. Take each tablet with enough water to be sure that you swallow it completely. Swallow Xartemis XR extended-release tablets immediately after you place it in your mouth.
  • Do not suddenly stop taking Xartemis XR extended-release tablets. You may have an increased risk of withdrawal symptoms. If you need to stop Xartemis XR extended-release tablets, your doctor will gradually lower your dose.
  • If you miss a dose of Xartemis XR extended-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you are not sure what to do, call your doctor.

Ask your health care provider any questions you may have about how to use Xartemis XR extended-release tablets.

Important safety information:

  • Xartemis XR extended-release tablets may cause dizziness, light-headedness, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Xartemis XR extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Xartemis XR extended-release tablets may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking Xartemis XR extended-release tablets. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Xartemis XR extended-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or take more often than prescribed without checking with your doctor.
  • If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
  • Tell your doctor or dentist that you take Xartemis XR extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Do not switch between this product and other products that contain the same medicines without checking with your doctor.
  • Xartemis XR extended-release tablets may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Xartemis XR extended-release tablets, talk with your doctor or pharmacist.
  • Xartemis XR extended-release tablets may harm your liver. Your risk may be greater if you drink alcohol while you are using Xartemis XR extended-release tablets. Talk to your doctor before you take Xartemis XR extended-release tablets or other fever reducers if you drink alcohol.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Xartemis XR extended-release tablets has acetaminophen in it. Do not take other products that contain acetaminophen while taking Xartemis XR extended-release tablets. If you are not sure if another product contains acetaminophen, check with your doctor or pharmacist.
  • Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.
  • Xartemis XR extended-release tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Xartemis XR extended-release tablets.
  • Use Xartemis XR extended-release tablets with caution in the ELDERLY; they may be more sensitive to its side effects, especially breathing problems and drowsiness.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xartemis XR extended-release tablets while you are pregnant. Long-term use of Xartemis XR extended-release tablets during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Xartemis XR extended-release tablets is found in breast milk. Do not breast-feed while taking Xartemis XR extended-release tablets.

When used for long periods of time or at high doses, Xartemis XR extended-release tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Xartemis XR extended-release tablets stops working well. Do not take more than prescribed.

Some people who use Xartemis XR extended-release tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Xartemis XR extended-release tablets, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Xartemis XR extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); abnormal sighing; burning, numbness, or tingling; change in amount of urine produced; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; hearing loss; memory problems; mental or mood changes (eg, agitation, anxiety); seizures; severe or persistent dizziness, drowsiness, headache, or light-headedness; severe or persistent stomach pain, constipation, or vomiting; shortness of breath; slow, shallow, or difficult breathing; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, persistent loss of appetite); tremor; trouble talking, thinking, or walking; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Xartemis XR extended-release tablets:

Store Xartemis XR extended-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xartemis XR extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Xartemis XR extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Xartemis XR extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Xartemis XR extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xartemis XR extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Xartemis XR extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Xartemis XR extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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