Xartemis Xr

Xartemis Xr Manufacturers

• Pd-rx Pharmaceuticals, Inc.
  

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  Xartemis Xr | Pd-rx Pharmaceuticals, Inc.

  

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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.

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• Mallinckrodt, Inc
  

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  Xartemis Xr | International Labs, Inc.

  

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  2.1 General Dosing Information

  The patient should be placed on a standard cholesterol-lowering diet before receiving pravastatin sodium tablets USP and should continue on this diet during treatment with pravastatin sodium tablets USP [see NCEP Treatment Guidelines for details on dietary therapy].

  2.2 Adult Patients

  The recommended starting dose is 40 mg once daily. If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. In patients with significant renal impairment, a starting dose of 10 mg daily is recommended. Pravastatin sodium tablets can be administered orally as a single dose at any time of the day, with or without food. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.

  2.3 Pediatric Patients

  Children (Ages 8 to 13 Years, Inclusive)

  The recommended dose is 20 mg once daily in children 8 to 13 years of age. Doses greater than 20 mg have not been studied in this patient population.

  Adolescents (Ages 14 to 18 Years)

  The recommended starting dose is 40 mg once daily in adolescents 14 to 18 years of age. Doses greater than 40 mg have not been studied in this patient population.

  Children and adolescents treated with pravastatin should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C [see Indications and Usage (1.2)].

  2.4 Concomitant Lipid-Altering Therapy

  Pravastatin sodium tablets may be used with bile acid resins. When administering a bile-acid-binding resin (e.g., cholestyramine, colestipol) and pravastatin, pravastatin sodium tablets should be given either 1 hour or more before or at least 4 hours following the resin [see Clinical Pharmacology (12.3)].

  2.5 Dosage in Patients Taking Cyclosporine

  In patients taking immunosuppressive drugs such as cyclosporine concomitantly with pravastatin, therapy should begin with 10 mg of pravastatin sodium once-a-day at bedtime and titration to higher doses should be done with caution. Most patients treated with this combination received a maximum pravastatin sodium dose of 20 mg/day. In patients taking cyclosporine, therapy should be limited to 20 mg of pravastatin sodium once daily [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].

  2.6 Dosage in Patients Taking Clarithromycin

  In patients taking clarithromycin, therapy should be limited to 40 mg of pravastatin sodium once daily [see Drug Interactions (7.2)].

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