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NUVIGIL (ARMODAFINIL) TABLETS: PHARMACOKINETICS FOR DRUG-DRUG INTERACTIONS

The existence of multiple pathways for armodafinil metabolism, as well as the fact that a nonCYP-related pathway is the most rapid in metabolizing armodafinil, suggest that there is a low probability of substantive effects on the overall pharmacokinetic profile of Nuvigil due to CYP inhibition by concomitant medications.

In vitro data demonstrated that armodafinil shows a weak inductive response for CYP1A2 and possibly CYP3A activities in a concentration-related manner and that CYP2C19 activity is reversibly inhibited by armodafinil. Other CYP activities did not appear to be affected by armodafinil. An in vitro study demonstrated that armodafinil is a substrate of P-glycoprotein.

Chronic administration of Armodafinil (Nuvigil) tablets at 250 mg reduced the systemic exposure to midazolam by 32% and 17% after single oral (5 mg) and intravenous (2 mg) doses, respectively, suggesting that administration of Nuvigil moderately induces CYP3A activity. Drugs that are substrates for CYP3A4/5, such as cyclosporine, may require dosage adjustment.

Chronic administration of Nuvigil (Armodafinil) at 250 mg did not affect the pharmacokinetics of caffeine (200 mg), a probe substrate for CYP1A2 activity.

Coadministration of a single 400 mg dose of Nuvigil with omeprazole (40 mg) increased systemic exposure to omeprazole by approximately 40%, indicating that armodafinil moderately inhibits CYP2C19 activity. Drugs that are substrates for CYP2C19 may require dosage reduction.

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