Xartemis XR Dosage

2.1 Important Dosage and Administration Instructions

XARTEMIS XR is not interchangeable with other oxycodone/acetaminophen products because of differing pharmacokinetic profiles that affect the frequency of administration.

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
• Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, 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 to 72 hours of initiating therapy and following dosage increases with XARTEMIS XR and adjust the dosage accordingly [see Warnings and Precautions (5.2)].

XARTEMIS XR is given orally. Instruct patients to swallow XARTEMIS XR tablets 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 4,000 milligrams.

2.2 Initial Dosage

Use of XARTEMIS XR as the First Opioid Analgesic

The recommended dosage 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.

2.3 Dosage Modifications in Patients with Hepatic Impairment

In patients with hepatic impairment start with one tablet and adjust dosage as needed. Monitor closely for respiratory depression, sedation, and hypotension [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.4 Dosage Modifications in Patients with Renal Impairment

In patients with renal impairment start with one tablet and adjust dosage as needed. Monitor closely for respiratory depression, sedation, and hypotension [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.5 Dosage Modifications with Concomitant Use of Central Nervous System Depressants

If the patient is currently taking a central nervous system (CNS) depressant and the decision is made to begin XARTEMIS XR, start with one tablet every 12 hours, consider using a lower dosage of the concomitant CNS depressant, and monitor patients for signs of respiratory depression, sedation, and hypotension [see Warnings and Precautions (5.6), Drug Interactions (7)].

2.6 Discontinuation of XARTEMIS XR

When a patient who has been taking XARTEMIS XR regularly and may be physically dependent no longer requires therapy with XARTEMIS XR, taper the dose gradually, by 25% to 50% every 2 to 4 days while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue XARTEMIS XR in a physically-dependent patient [see Warnings and Precautions (5), Drug Abuse and Dependence (9.3)].