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Modafinil (Provigil)
(moh- DEH-fin-ill)
Pregnancy Category: C Provigil (Rx) (C-IV)

Classification: Analeptic

Action/Kinetics: Precise mechanism unknown. Has wake-promoting effects similar to amphetamine and methylphenidate. Produces psychoactive and euphoric effects; alterations in mood, perception, and thinking; and, feelings typical of other CNS stimulants. Rapidly absorbed. Peak plasma levels: 2-4 hr. Absorption may be delayed by about 1 hr if taken with food. Metabolized by the liver and excreted in the urine. After chronic use, may induce its own metabolism. Clearance may be decreased in the elderly.

Uses: Improve wakefulness in clients with excessive daytime sleepiness associated with narcolepsy.

Special Concerns: Use with caution, and at reduced doses, in severe hepatic impairment. Safety and efficacy in clients over 65 years of age or in children less than 16 years of age have not been determined. Use with caution during lactation. Is a reinforcing drug; use may lead to abuse/dependence. Thus, use with caution in those with a history of drug or stimulant abuse. Use with caution when coadministered with drugs that depend on CYP1A2, CYP2B6, or CYP3A4 for their clearance as lower blood levels of such drugs could result.

Side Effects: CNS: Headache, nervousness, dizziness, depression, anxiety, cataplexy, insomnia, paresthesia, oro-facial dyskinesia, hypertonia, confusion, amnesia, emotional lability, ataxia, tremor. GI: N&V, diarrhea, dry mouth, anorexia, mouth ulcer, gingivitis, thirst. CV: Hypotension, hypertension, vasodilation, arrhythmia, syncope. Dermatologic: Herpes simplex, dry skin. GU: Abnormal urine, urinary retention, abnormal ejaculation. Respiratory: Rhinitis, pharyngitis, lung disorder, dyspnea, asthma, epistaxis. Ophthalmic: Amblyopia, abnormal vision. Miscellaneous: Infection, chest pain, neck pain, eosinophilia, rigid neck, fever, chills, joint disorder.

Laboratory Test Alterations: Liver enzymes, GGT. Albuminuria, hyperglycemia.

Overdose Management: Symptoms: Excitation, agitation, insomnia, slight to moderate increases in hemodynamic parameters. Treatment: Supportive care, including CV monitoring. Consider inducing emesis or gastric lavage.

Drug Interactions: Cyclosporine / Possible blood levels of modafinil MAO inhibitors / Use caution when taken together Methylphenidate / Delayed absorption (by 1 hr) of modafinil Oral contraceptives / Possible effectiveness of oral contraceptives Phenytoin / Possible phenytoin toxicity Tricyclic antidepressants / Possible plasma levels of clomipramine or desipramine Warfarin / Possible effects of warfarin

How Supplied: Tablets: 100 mg, 200 mg

?Tablets Narcolepsy.
Adults: 200 mg/day as a single dose in the morning. Doses of 400 mg/day are well tolerated but no data to indicate increased beneficial effect. In clients with impaired hepatic function reduce the dose by 50%. Consider lower doses in elderly clients.

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