Armodafinil: uses, dosing, side effects & brands

The following serious adverse reactions are described below and elsewhere in the labeling: Serious Dermatologic Reactions [see Warnings and Precautions ( 5.1 )] Drug Reaction with Eosinophilia and System Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.2 )] Angioedema and Anaphylaxis Reactions [see Warnings and Precautions ( 5.3 )] Persistent Sleepiness [see Warnings and Precautions ( 5.4 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.5 )] Effects on Ability to Drive and Use Machinery [see Warnings and Precautions ( 5.6 )] Cardiovascular Events [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥5%): headache, nausea, dizziness, and insomnia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. NUVIGIL has been evaluated for safety in over 1,100 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy. Most Common Adverse Reactions In the placebo-controlled clinical trials, the most common adverse reactions (≥5%) associated…

NUVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . NUVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil. ( 4 )

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 one month 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 one month 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. Steroidal contraceptives (e.g., ethinyl estradiol): use alternative or concomitant methods of contraception while taking NUVIGIL and for one month after discontinuation of NUVIGIL treatment. ( 7 ) Cyclosporine: blood concentrations of cyclosporine may be reduced. ( 7 ) CYP2C19 substrates, such as omeprazole, phenytoin, and diazepam: exposure of these medications may be increased. ( 7 )