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NUVIGIL
Sleep-wake disorders
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Drug Name:

NUVIGIL CIV

Generic Name and Formulations:
Armodafinil 50mg, 150mg, 200mg, 250mg; tabs.

Company:
Teva Pharmaceuticals

Therapeutic Use:

Indications for NUVIGIL:

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

Adult:

≥17yrs: OSAHS, narcolepsy: 150mg or 250mg once daily in the AM. SWSD: 150mg one hour before starting shift. Severe hepatic impairment: reduce dose.

Children:

<17yrs: not recommended.

Warnings/Precautions:

Discontinue if rash, sores, blistering, or ulceration appears (unless clearly not drug-related), or if angioedema, anaphylaxis, or DRESS/multi-organ hypersensitivity reaction occurs. OSAHS: treat underlying obstruction; maintain CPAP use if indicated. History of LV hypertrophy or mitral valve prolapse syndrome (eg, ischemic ECG changes, chest pain, arrhythmias associated with CNS stimulants): not recommended. Recent MI. Unstable angina. Monitor BP. History of psychosis, depression, or mania; consider discontinuing if psychiatric symptoms develop. Severe hepatic or renal impairment. Reevaluate periodically. Elderly (may need to reduce dose). Labor & delivery. Pregnancy. Nursing mothers.

Interactions:

May antagonize hormonal contraceptives; use alternative or additional contraception during and for 1 month after. Avoid alcohol. Caution with MAOIs. Armodafinil levels may be decreased by CYP3A4 inducers (eg, carbamazepine, phenobarbital, rifampin) and increased by CYP3A4 inhibitors (eg, ketoconazole, erythromycin). May reduce levels of drugs metabolized by CYP3A4 (eg, cyclosporine). May increase levels of drugs metabolized by CYP2C9 (eg, warfarin) or CYP2C19 (eg, phenytoin, diazepam, propranolol).

Pharmacological Class:

Wakefulness-promoter.

Adverse Reactions:

Headache, insomnia, other CNS effects, GI upset; rash (may be serious, eg, Stevens-Johnson, toxic epidermal necrolysis), DRESS/multiorgan hypersensitivity.

Note:

Register pregnant patients exposed to Nuvigil by calling (866) 404-4106.

Generic Availability:

YES

How Supplied:

Tabs—30

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