"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
Limitations Of Use
Because of the risks of addiction, abuse, misuse, overdose, and death with opioids, even at recommended doses, reserve XARTEMIS XR for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate.
DOSAGE AND ADMINISTRATION
Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with XARTEMIS XR [see WARNINGS AND PRECAUTIONS].
Use Of XARTEMIS XR As The First Opioid Analgesic
The recommended dose of XARTEMIS XR is 2 tablets every 12 hours administered with or without food. The second dose of 2 tablets may be administered as early as 8 hours after the initial dose if patients require analgesia at that time. Subsequent doses are to be administered 2 tablets every 12 hours.
XARTEMIS XR is given orally. XARTEMIS XR tablets should be swallowed whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in mouth [see PATIENT INFORMATION]. Do not break, chew, crush, cut, dissolve or split the tablets. Breaking, chewing, crushing, cutting, dissolving or splitting XARTEMIS XR tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see WARNINGS AND PRECAUTIONS].
The total daily dose of acetaminophen from all drug products should not exceed 4000 milligrams.
In patients with hepatic impairment start with one tablet and adjust dosage as needed. Monitor closely for respiratory depression [see CLINICAL PHARMACOLOGY].
In patients with renal impairment start with one tablet and adjust dosage as needed. Monitor closely for respiratory depression [see CLINICAL PHARMACOLOGY].
Cessation Of Therapy
When a patient who has been taking XARTEMIS XR regularly and may be physically dependent no longer requires therapy with XARTEMIS XR use a gradual downward titration of the dose of 50% every 2 to 4 days to prevent signs and symptoms of withdrawal. Do not stop XARTEMIS XR abruptly in patients who may be physically dependent.
Dosage Forms And Strengths
XARTEMIS XR is an extended-release tablet for oral administration. Each tablet contains 7.5 mg oxycodone hydrochloride and 325 mg acetaminophen.
Storage And Handling
XARTEMIS XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets are oval shaped tablets with a blue coating, debossed with “M” in a box over “115” on one side of the tablet. Each tablet contains 7.5 mg oxycodone hydrochloride and 325 mg acetaminophen and is packaged in bottles and blister packs.
Bottles of 100 NDC 23635-115-01
Unit dose (10 x 10) NDC 23635-115-62
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
DEA FORM REQUIRED
Distributed by: Mallinckrodt Brand Pharmaceuticals, Inc., Hazelwood, MO 63042 USA, www.Mallinckrodt.com or call 1-800-778-7898. Revised: Mar 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/24/2016
Additional Xartemis XR Information
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