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Drug Information

Drug Information for 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

Dose proportionality has been established for the 10 mg, 20 mg, 40 mg, and 80 mg tablet strengths for both peak plasma concentrations (C_max) 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 (C_max) 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 C_max, and similar for C_min (trough) concentrations.

TABLE 1 Mean [% coefficient variation]
Regimen	Dosage Form	AUC(ng•hr/mL)†	C_max(ng/mL)	T_max(hrs)	Trough Conc.(ng/mL)

SingleDose	10 mg OxyContin	100.7 [26.6]	10.6 [20.1]	2.7 [44.1]	n.a.
	20 mg OxyContin	207.5 [35.9]	21.4 [36.6]	3.2 [57.9]	n.a.
	40 mg OxyContin	423.1 [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.

MultipleDose	10 mg OxyContin Tablets q12h	103.6 [38.6]	15.1 [31.0]	3.2 [69.5]	7.2 [48.1]
	5 mg immediate- release q6h	99.0 [36.2]	15.5 [28.8]	1.6 [49.7]	7.4 [50.9]

TABLE 2 Mean [% coefficient variation]
Regimen	Dosage Form	AUC₈(ng•hr/mL)†	C_max(ng/mL)	T_max(hrs)	Trough Conc.(ng/mL)
† for single-dose AUC = AUC_0-inf; for multiple-dose AUC = AUC_0-T
* data obtained while volunteers received naltrexone which can enhance absorption
SingleDose	4 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 C_max 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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