Provigil


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modafinil

Alertec (CA), Apo-Mofafinil (CA), Provigil

Pharmacologic class: Nonamphetamine CNS stimulant

Therapeutic class: Analeptic

Controlled substance schedule IV

Pregnancy risk category C

Action

Unknown. Thought to stimulate CNS by decreasing the release of gamma-aminobutyric acid (a CNS depressant), thereby increasing mental alertness.

Availability

Tablets: 100 mg, 200 mg

Indications and dosages

Narcolepsy

Adults: 200 mg/day P.O. as a single dose in morning

Dosage adjustment

• Severe hepatic impairment

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• recent myocardial infarction, unstable angina, severe hepatic impairment, hyperthyroidism, hypertension, glaucoma, anxiety
• history of left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmias, or mitral valve prolapse with previous CNS stimulant use
• history of psychosis
• drug abuse
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Give without food (food delays drug absorption).

Adverse reactions

CNS: headache, dizziness, nervousness, insomnia, depression, anxiety, amnesia, tremor, emotional lability

CV: hypertension, chest pain, vasodilation, hypotension, syncope, arrhythmias

EENT: abnormal vision, amblyopia, epistaxis, rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, dry mouth, anorexia

GU: abnormal urine, urinary retention, albuminuria, abnormal ejaculation

Hematologic: eosinophilia

Metabolic: hyperglycemia

Musculoskeletal: joint disorders, neck pain and rigidity

Respiratory: lung disorder, dyspnea, asthma

Skin: dry skin

Other: fever, chills, herpes simplex infection

Interactions

Drug-drug.Carbamazepine, phenobarbital, rifampin, other CYP3A4 inducers: decreased modafinil blood level

Cyclosporine, theophylline: decreased blood levels of these drugs

Diazepam, phenytoin, propranolol, tricyclic antidepressants, warfarin: increased blood levels of these drugs

Hormonal contraceptives: decreased contraceptive efficacy

Itraconazole, ketoconazole, other CYP3A4 inhibitors: increased modafinil blood level

Methylphenidate: delayed modafinil absorption

Drug-diagnostic tests.Aspartate aminotransferase, eosinophils, gamma-glutamyl transferase, glucose: increased levels

Hepatic enzymes: abnormal levels

Patient monitoring

• Monitor respiratory and cardiovascular status, including vital signs and ECG.
• Monitor neurologic status, including mood, motor function, cognition, and emotional lability.
• Monitor blood glucose level in diabetic patient.
• Monitor patient carefully if he is also receiving MAO inhibitors. (However, interaction studies with MAO inhibitors haven't been done.)

Patient teaching

• Tell patient he may take with or without food, but that food may delay drug absorption up to 1 hour.

Advise patient to immediately report chest pain, irregular heart beats, light-headedness, or fainting.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, vision, motor function, and alertness.
• Instruct female patient to use reliable nonhormonal contraception during and for 1 month after therapy.
• Tell diabetic patient to monitor blood glucose level closely and stay alert for hyperglycemia.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

Provigil

(prō-vĭj′əl)
A trademark for the drug modafinil.

Provigil®

Modafinil, see there.

Provigil

A brand name for MODAFINIL.
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in 2011, had improperly delayed the introduction of a generic competitor to Provigil.
Time, Place]: Provigil is the most effective remedy for sleep disorders and also for enhancing wakefulness in men and women.
Provigil is a drug that treats sleep disorders, and as of 2011, it made more than $1 billion in sales.
6) In addition to enhancing the user's ability to sustain concentration, Provigil promotes wakefulness even in users who have experienced prolonged sleep deprivation.
Huffing to Post journalist Johann Hari, who took Provigil for an article he wrote on the subject, said he became more productive--but also more withdrawn.
It shot to fame when Dave Asprey, the founder of The Bulletproof Executive and self-described "biohacker" credited the use of Provigil to his success in Silicon Valley.
The company's Modafinil Tablets is the generic version of Cephalon's Provigil Tablets and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder.
M2 EQUITYBITES-August 13, 2012-Mylan Inc unveils FDA approved generic Provigil Tablets(C)2012 M2 COMMUNICATIONS http://www.
Provigil is indicated for the treatment of excessive daytime sleepiness.
The transaction has been approved by the US Federal Trade Commission (FTC) last week, after Teva agreed to give marketing rights to its Provigil drug to sector firm Par Pharmaceuticals (NYSE:PRX) for one year, and to sell Par the rights and assets of the generic versions of the Actiq and Amrix drugs.
European Union regulators are checking up on whether Cephalon and generic drug giant Teva Pharmaceuticals went against antitrust rules by agreeing to a deal under which a generic for Provigil, Cephalon s narcolepsy and sleep disorder drug, won t appear in Europe until next year.
The agreement, the biggest so far in stem-cell therapies, gives Cephalon potential new products to counter the loss of revenue from Provigil, the sleep-disorder drug facing competition from cheaper generic versions.