Interactions : אינטראקציות

7. DRUG INTERACTIONS

Effects of NUVIGIL on CYP3A4/5 Substrates
The clearance of drugs that are substrates for CYP3A4/5 (e.g., steroidal contraceptives, cyclosporine, midazolam, and triazolam) may be increased by NUVIGIL via induction of metabolic enzymes, which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when these drugs are used concomitantly with NUVIGIL [see Clinical Pharmacology (12.3)].

The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for two months after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with NUVIGIL and for two months after discontinuation of NUVIGIL treatment.

Blood levels of cyclosporine may be reduced when used with NUVIGIL. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when used concomitantly with NUVIGIL.

Effects of NUVIGIL on CYP2C19 Substrates

Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by
NUVIGIL via inhibition of metabolic enzymes, with resultant higher systemic exposure. Dose reduction of these drugs may be required when these drugs are used concomitantly with NUVIGIL.

Warfarin

More frequent monitoring of prothrombin times/INR should be considered whenever NUVIGIL is coadministered with warfarin [see Clinical Pharmacology (12.3)].

Monoamine Oxidase (MAO) Inhibitors

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