Xartemis XR Dosage
Generic name: OXYCODONE HYDROCHLORIDE 7.5mg, ACETAMINOPHEN 325mg
Dosage form: tablet, coated
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XARTEMIS XR is not interchangeable with other oxycodone/acetaminophen products because of differing pharmacokinetic profiles that affect the frequency of administration.
2.1 Initial Dosage
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 (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with XARTEMIS XR [see Warnings and Precautions (5.2)].
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 Counseling Information (17)]. 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 (5.1)].
The total daily dose of acetaminophen from all drug products should not exceed 4000 milligrams.
2.2 Hepatic Impairment
In patients with hepatic impairment start with one tablet and adjust dosage as needed. Monitor closely for respiratory depression [see Clinical Pharmacology (12.3)].
2.3 Renal Impairment
In patients with renal impairment start with one tablet and adjust dosage as needed. Monitor closely for respiratory depression [see Clinical Pharmacology (12.3)].
2.4 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.