Generic Name and Formulations:
Modafinil 100mg, 200mg+; tabs; +scored.

Company:
Cephalon, Inc.
Indications for PROVIGIL:
To improve wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD). Adjunct to standard treatment for underlying airway obstruction in OSAHS.

Adult:
≥16yrs: 200mg once daily in the AM; SWSD: take dose 1hr before work. Max 400mg/day. Severe hepatic impairment: 100mg once daily in the AM. Elderly, severe renal impairment, concomitant CYP3A4 substrates or drugs eliminated by CYP2C19: see literature.

Children:
<16yrs: not recommended.

Pharmacological Class:
Wakefulness-promoter.

Warnings/Precautions:
OSAHS: treat underlying obstruction. History of LV hypertrophy or symptomatic mitral valve prolapse (eg, ischemic ECG changes, chest pain, arrhythmias associated with CNS stimulants): not recommended. Discontinue if rash appears (unless clearly not drug-related), or if angioedema, anaphylaxis, or multi-organ hypersensitivity reaction occurs. Recent MI. Unstable angina. Hypertension (monitor BP). Cardiovascular disease. Psychosis. Severe hepatic or renal impairment. Reeva luate periodically. Elderly. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

Interactions:
May antagonize hormonal contraceptives; use alternative or additional contraceptive method during and for one month after treatment. Avoid alcohol. Caution with MAOIs. Modafinil levels may be decreased by CYP3A4 inducers (eg, carbamazepine, phenobarbital, rifampin) and increased by CYP3A4 inhibitors (eg, ketoconazole, itraconazole). May decrease levels of drugs metabolized by CYP3A4 or CYP1A2 (eg, cyclosporine), or CYP2B6. May increase levels of drugs metabolized by CYP2C9 (eg, warfarin) or CYP2C19 (eg, phenytoin, diazepam, propranolol), and levels of tricyclics and SSRIs in patients deficient in CYP2D6 (consider dose reduction). Monitor warfarin, phenytoin.

Adverse Reactions:
Headache, infection, GI upset, nervousness, rhinitis, back pain, anxiety, depression, insomnia, other CNS effects, rash (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis): may be serious, life-threatening, or become permanently disabling or disfiguring.

How Supplied:
Tabs—100