Xartemis XR

Xartemis XR is a prescription medication used to treat certain types of short term (acute) pain. It is a single product containing 2 medications: oxycodone and acetaminophen. Xartemis XR belongs to a group of drugs called analgesics, which work by altering the way the brain and nervous system sense pain.

This medication comes in an extended release tablet formulation that is typically taken every 12 hours with or without food. 

Swallow Xartemis XR tablets whole. Do not cut, break, chew, crush, dissolve, snort or inject Xartemis XR tablets. 

Common side effects of Xartemis XR include nausea, dizziness, and headache. Xartemis XR can also cause drowsiness. Do not drive or operate heavy machinery until you know how Xartemis XR affects you.

Xartemis XR is a prescription medication used to treat certain types of short term (acute) pain. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Mallinckrodt Inc (Brand Pharmaceuticals)

Serious side effects have been reported with Xartemis XR. See the "Xartemis XR Precautions" section. 

Common side effects of Xartemis XR include the following:

• nausea
• dizziness
• headache
• vomiting
• constipation
• sleepiness

This is not a complete list of Xartemis XR side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Especially tell your doctor if you take or use:

• medications that slow the central nervous system down (CNS depressants) such as sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol
• medicines that relax skeletal muscles such as carisoprodol (Soma) and cyclobenzaprine (Flexeril)
• monoamine oxidase inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), and rasagiline (Azilect)
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin, St John's wort, and nimodipine (Nimotop)
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril), and paroxetine (Paxil)
• anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro­Banthine), and atropine (Atropen, Sal­Tropine)
• certain analgesics like pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), and buprenorphine (Butrans)

This is not a complete list of Xartemis XR drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xartemis XR including the following:

• Xartemis XR is not interchangeable with other oxycodone/ acetaminophen products because they are released in the body differently and are taken differently 
• Controlled substance: Xartemis XR is a Schedule II controlled substance with an abuse liability similar to other opioids. 
• Accidental exposure, especially in children, can result in fatal overdose of oxycodone.
• Increased tolerance and physical dependence with this medication. Xartemis XR is also a high-risk medication for addiction.
  • Tolerance - the need for increasing doses of this medication to maintain pain relief (in the absence of worsening disease or other factors)
  • Physical dependence - when withdrawal symptoms occur due to suddenly discontinuation of this medication: Withdrawal symptoms include: restlessness, excessive tears formation, runny nose, yawning, sweating, chills, muscle aches, irritability, or anxiety
  • Addiction: abnormal or compulsive use of a substance for non-medical needs
• Hypersensitivity reaction to Xartemis XR (oxycodone or acetaminophen). Tell your healthcare provider right away if you have some or all of the following symptoms of:
  • hives
  • rash
  • difficulty breathing or swallowing
  • itching
  • swelling
• Respiratory depression. Tell your healthcare provider right away if you have difficulty of breathing while taking this medication. Your doctor will monitor you especially elderly, cachectic, debilitated patients, and patients with chronic pulmonary disease. 
• Withdrawal symptoms in newborn. Prolonged use of Xartemis XR during pregnancy can result in withdrawal signs in the baby.
• Head injury. Xartemis XR may worsen the adverse of effects in patients with a previous head injury (e.g. change in mental function, increased difficulty in breathing).
• Orthostatic hypotension (low blood pressure when rising). Tell your healthcare provider right away if  have symptoms of:
  • dizziness after rising from sitting or laying down
  • low blood pressure
• Liver toxicity. This may occur with excessive use of acetaminophen (greater than 4 grams per day or with alcohol use/abuse). Do not use this medication with other acetaminophen-containing products. Tell your healthcare provider right away if have symptoms of:
  • nausea
  • vomiting
  • sweating
  • fatigue
• Serious skin reactions. Symptoms may include skin reddening, rash, blisters, and the upper surface of the skin may become separated from the lower layers. This can occur even if you have taken acetaminophen in the past without any problems. If you develop any skin rash or reaction while using a medication containing acetaminophen, including this medication, stop the medication and seek medical attention immediately. If you have had a serious skin reaction with acetaminophen, do not take it or any products containing acetaminophen again. Doing so could cause you to have another serious skin reaction.
• Difficulty swallowing. This can occur because the tablets swell and become sticky when wet. Do not pre-soak, lick or otherwise wet Xartemis XR tablets prior to placing in mouth, and take one tablet at a time with enough water to ensure complete swallowing immediately after placing in mouth.
• Multiple drug interactions. Xartemis XR can interact with many medications that can lead to profound sedation, respiratory depression, and death. If you require both medications, then your doctor may adjust your doses. 

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, low blood pressure when changing positions, or you are feeling faint.
• rash with hives, sores in your mouth or eyes, or your skin blisters and peels.

Xartemis XR can cause drowsiness. Do not drive or operate heavy machinery until you know how Xartemis XR affects you. 

Do not drink alcohol while taking Xartemis XR.

Do not take other products that contain acetaminophen while taking Xartemis XR.

Do not take Xartemis XR if you:

• are allergic to Xartemis XR or to any of its ingredients (acetaminophen or oxycodone)
• have severe asthma, trouble breathing, or other lung problems.
• have a bowel blockage or have narrowing of the stomach or intestines.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xartemis XR, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Xartemis XR, tell your doctor about all of your medical conditions. Especially tell your doctor if you have a history of:

• an allergy to Xartemis XR or to any other ingredients in this formulation
• head injury, seizures 
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.
• liver, kidney, thyroid problems       
• pancreas or gallbladder problems
• pregnant or planning to become pregnant. Prolonged use during pregnancy can cause life-threatening withdrawal symptoms in your newborn baby if not recognized and treated.
• breastfeeding or plan to breastfeed. Xartemis XR passes into breast milk and may harm your baby. 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Xartemis XR falls into category C. No well-controlled studies have been done in pregnant women. Xartemis XR cause can harm to your unborn baby. 

Prolonged use of Xartemis XR during pregnancy can cause life-threatening withdrawal symptoms in your newborn baby if not recognized and treated.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Oxycodone, one of the components of Xartemis XR, is present in human milk and may result in sleepiness and breathing issues in some infants. Acetaminophen, the other component of Xartemis XR, is present in human milk in small quantities. Because of the possibility for adverse reactions in nursing infants from Xartemis XR, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Xartemis XR exactly as prescribed.

• Do not change your dose. Take Xartemis XR exactly as prescribed by your healthcare provider.
• Take your prescribed dose every 12 hours, at the same time every day. If you miss a dose, take Xartemis XR as soon as possible, then take your next dose 12 hours later. If it is almost time for your next dose, skip the missed dose. Take your next dose at the regular time. Do not take more than your prescribed daily dose in 24 hours.
• Swallow Xartemis XR whole. Do not cut, break, chew, crush, dissolve, snort or inject Xartemis XR because this may cause you to overdose and die. You should not receive Xartemis XR through a nasogastric tube or gastric tube (stomach tube).
• Take Xartemis XR 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth. Take each Xartemis XR tablet with enough water to be sure that you swallow it completely as soon as you place it in your mouth.
• Call your healthcare provider if Xartemis XR does not control your pain.
• If you have been taking Xartemis XR for more than a few days, do not stop taking it without talking to your healthcare provider.
• Do not drive or operate heavy machinery, until you know how Xartemis XR affects you. Xartemis XR can make you sleepy, dizzy, or lightheaded.
• Do not drink alcohol while on this medication.
• Do not take other products that contain acetaminophen while taking Xartemis XR.

Take Xartemis XR exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Xartemis XR dose your doctor recommends will be based on the following:

• the condition being treated
• previous pain treatments
• risk for addiction, abuse, and misuse of Xartemis XR
• how you respond to this medication
• how well your kidney works

The recommended dose for Xartemis XR for the treatment of pain is 2 tablets every 12 hours with or without food. 

• The second dose of 2 tablets may be administered as early as 8 hours after the first dose if you require pain relief at that time. Doses that follow should be taken every 12 hours.

If you take too much Xartemis XR, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 59° to 86°F (15° to 30°C).
• Keep this medication in a secure place out of reach from children.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and HEPATOTOXICITY

Addiction, Abuse, and Misuse
XARTEMIS XR exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing XARTEMIS XR, and monitor all patients regularly for the development of these behaviors or conditions.

Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of XARTEMIS XR. Monitor for respiratory depression, especially during initiation of XARTEMIS XR or following a dose increase. Instruct patients to swallow XARTEMIS XR tablets whole; crushing, chewing, or dissolving XARTEMIS XR can cause rapid release and absorption of a potentially fatal dose of oxycodone.

Accidental Exposure
Accidental ingestion of XARTEMIS XR, especially in children, can result in a fatal overdose of oxycodone.

Neonatal Opioid Withdrawal Syndrome
Prolonged use of XARTEMIS XR during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Hepatotoxicity
XARTEMIS XR contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limit, and often involve more than one acetaminophen-containing product.