Pharmacokinetic Profile

Pain Relief
Dependable Product Profile
Flexible Dosing
Opioid Conversions
Drug-Drug Interactions

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Opana® ER with INTAC® technology1 had no significant difference in the rate and extent of absorption compared to the original formulation over 12 hours2,*

Mean oxymorphone plasma concentrations under fasted conditions after single oral dose of original formulation and Opana® ER (INTAC)

The correlation of pharmacokinetics to clinical effects has not been established

  • With all doses and administration conditions (fasted or fed), the oxymorphone plasma concentration versus time profile was similar overall.2

Original formulation of Opana® ER offers true 12-hour dosing

Steady-state oxymorphone plasma concentrations (Day 8)3,*

The correlation of pharmacokinetics to clinical effects has not been established

  • Steady-state plasma concentrations are achieved after 3 days of multiple-dose administration.1
  • Under both single-dose and steady-state conditions, dose proportionality has been established for the 5-mg, 10-mg, 20-mg, and 40-mg tablet strengths for both peak plasma levels (Cmax) and extent of absorption (AUC).1
  • The half-life is 9.4 to 11.3 hours.1

References

  1. Opana® ER (Oxymorphone Hydrochloride) Extended-Release Tablets CII [Prescribing Information]. Endo Pharmaceuticals. Chadds Ford, PA; 2012.
  2. Benedek IH, Jobes J, Xiang Q, Fiske WD. Bioequivalence of oxymorphone extended release and crush-resistant oxymorphone extended release. Drug Des Dev Ther. 2011;5:455-463.
  3. Adams M, Ahdieh H. Pharmacokinetics and dose-proportionality of oxymorphone extended release and its metabolites: results of a randomized crossover study. Pharmacotherapy. 2004;24(4):468-476.