Información de la droga para OXYCONTIN (OXYCODONE HCl CONTROLLED-RELEASE) TABLETS CII10 mg 15 mg 20 mg 30 mg 40 mg 60 mg* 80 mg* 160 mg* (Purdue Pharma LP): Plasma Oxycodone by Time

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  • Dose proportionality has been established for the 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for both peak plasma concentrations (Cmax) and extent of absorption (AUC) (see Table 1 below). Another study established that the 160 mg tablet is bioequivalent to 2 x 80 mg tablets as well as to 4 x 40 mg for both peak plasma concentrations (Cmax) and extent of absorption (AUC) (see Table 2 below). Given the short half-life of elimination of oxycodone from OxyContin®, steady-state plasma concentrations of oxycodone are achieved within 24-36 hours of initiation of dosing with OxyContin Tablets. In a study comparing 10 mg of OxyContin every 12 hours to 5 mg of immediate-release oxycodone every 6 hours, the two treatments were found to be equivalent for AUC and Cmax, and similar for Cmin (trough) concentrations.

    TABLE 1 Mean [% coefficient variation]
    RegimenDosage FormAUC(ng•hr/mL)†Cmax(ng/mL)Tmax(hrs)Trough Conc.(ng/mL)
    SingleDose10 mg OxyContin100.7 [26.6]10.6 [20.1]2.7 [44.1]n.a.
    20 mg OxyContin207.5 [35.9]21.4 [36.6]3.2 [57.9]n.a.
    40 mg OxyContin423.1 [33.3]39.3 [34.0]3.1 [77.4]n.a.
    80 mg OxyContin*1085.5 [32.3]98.5 [32.1]2.1 [52.3]n.a.
    MultipleDose10 mg OxyContin Tablets q12h103.6 [38.6]15.1 [31.0]3.2 [69.5]7.2 [48.1]
    5 mg immediate- release q6h99.0 [36.2]15.5 [28.8]1.6 [49.7]7.4 [50.9]
    TABLE 2 Mean [% coefficient variation]
    RegimenDosage FormAUC8(ng•hr/mL)†Cmax(ng/mL)Tmax(hrs)Trough Conc.(ng/mL)
    † for single-dose AUC = AUC0-inf; for multiple-dose AUC = AUC0-T
    * data obtained while volunteers received naltrexone which can enhance absorption
    SingleDose4 x 40 mgOxyContin*1935.3 [34.7]152.0 [28.9]2.56 [42.3]n.a.
    2 x 80 mgOxyContin*1859.3 [30.1]153.4 [25.1]2.78 [69.3]n.a.
    1 x 160 mgOxyContin*1856.4 [30.5]156.4 [24.8]2.54 [36.4]n.a.

    OxyContin® is NOT INDICATED FOR RECTAL ADMINISTRATION. Data from a study involving 21 normal volunteers show that OxyContin Tablets administered per rectum resulted in an AUC 39% greater and a Cmax 9% higher than tablets administered by mouth. Therefore, there is an increased risk of adverse events with rectal administration.

  • Drug Information Provided by National Library of Medicine (NLM).
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