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PROVIGIL
Sleep-wake disorders
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Drug Name:

PROVIGIL CIV

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

Company:
Cephalon, Inc.

Therapeutic Use:

Indications for PROVIGIL:

To improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

Limitations Of use:

In OSA: not for treating underlying obstruction.

Adult:

≥17yrs: 200mg once daily in the AM; SWD: take dose 1hr before work. Max 400mg/day. Severe hepatic impairment: 100mg once daily in the AM. Elderly, concomitant CYP3A4 substrates or drugs eliminated by CYP2C19: see full labeling.

Children:

<17yrs: not established.

Warnings/Precautions:

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. Monitor HR and BP. Cardiovascular disease. Psychosis. Depression. Mania. Severe hepatic impairment. Reevaluate periodically. Elderly. 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, erythromycin). May decrease levels of drugs metabolized by CYP3A4 (eg, cyclosporine, midazolam), CYP1A2 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.

Pharmacological Class:

Wakefulness-promoter.

Adverse Reactions:

Headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, dyspepsia; rash (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis).

How Supplied:

Tabs—30

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