Armodafinil

Strong CYP3A4 inducer may reduce plasma macimorelin concentrations and lead to false positive test results. Discontinue prior to use.

Elimination of clomipramine may be prolonged by armodafinil via inhibition of metabolic enzymes, resulting in higher systemic exposure. Dose reduction may be required.

Blood levels of cyclosporine may be reduced when used with armodafinil. Monitoring of circulating cyclosporine concentrations and dosage adjustment should be considered.

Elimination of diazepam may be prolonged by armodafinil via inhibition of metabolic enzymes, resulting in higher systemic exposure. Dose reduction may be required.

Concomitant use may increase blood pressure. Closely monitor blood pressure with concomitant use.

Effectiveness of steroidal contraceptives may be reduced when used with armodafinil. Alternative or concomitant methods of contraception are recommended during treatment and for one month after discontinuation.

Binds to dopamine transporter with high affinity and may interfere with Ioflupane I-123 imaging results.

Caution should be used when concomitantly administering MAO inhibitors and armodafinil.

Clearance of midazolam may be increased by armodafinil, resulting in lower systemic exposure. Dosage adjustment should be considered.

Caution should be used when concomitantly administering MAO inhibitors and armodafinil.

Effects of Armodafinil Tablets on CYP2C19 Substrates: Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by armodafinil tablets via inhibition of metabolic enzymes, with resultant higher systemic exposure. ( 7 ) • CYP2C19 substrates, such as omeprazole, phenytoin, and diazepam: exposure of these medications may be increased. In a clinical study, concomitant administration of armodafinil tablets 400 mg resulted in a 40% increase in exposure to omeprazole after a single oral dose (40 mg), as a result of moderate inhibition of CYP2C19 activity [see Drug Interactions (7) ].

Effectiveness of steroidal contraceptives may be reduced when used with armodafinil via CYP3A4/5 induction. Alternative or concomitant contraception methods recommended.

Elimination of phenytoin may be prolonged by armodafinil via inhibition of metabolic enzymes, resulting in higher systemic exposure. Dose reduction may be required.

Elimination of propranolol may be prolonged by armodafinil via inhibition of metabolic enzymes, resulting in higher systemic exposure. Dose reduction may be required.

Clearance of triazolam may be increased by armodafinil, resulting in lower systemic exposure. Dosage adjustment should be considered.

More frequent monitoring of prothrombin times/INR should be considered whenever armodafinil is coadministered with warfarin.

However, due to the partial involvement of CYP3A enzymes in the metabolic elimination of armodafinil, coadministration of potent inducers of CYP3A4/5 (e.g., carbamazepine, phenobarbital, rifampin) or inhibitors of CYP3A4/5 (e.g., ketoconazole, erythromycin) could alter the plasma concentrations of armodafinil.

However, due to the partial involvement of CYP3A enzymes in the metabolic elimination of armodafinil, coadministration of potent inducers of CYP3A4/5 (e.g., carbamazepine, phenobarbital, rifampin) or inhibitors of CYP3A4/5 (e.g., ketoconazole, erythromycin) could alter the plasma concentrations of armodafinil.