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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References in periodicals archive ?
As part of the settlement, Teva also has agreed to a prohibition on the type of anticompetitive patent settlements that Cephalon used to artificially inflate the price of Provigil.
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.
Worst of all, Provigil subdues the very natural and normal urge to sleep, masking someone's ability to tell when it's time to check out for the night.
Teva contracted not to sell generic Provigil in the United States or the European Union until 2012 as per the conditions of the deal.
Perhaps her secret is the Provigil medication spotted in her handbag in LA.
Modafinil, marketed as Provigil by Cephalon, is approved for improving wakefulness in people with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD).
Provigil has been used to treat excessive sleepiness caused by certain sleep disorders since 1999.
We believe the characteristics of the alcohol dependence market parallel those we encountered when we first launched PROVIGIL to treat excessive sleepiness.
She is being treated with a stimulant called Provigil, which is not prescribed for children in the UK.
The drug's creators hope it can enjoy similar success to Provigil - also called modafinil - which has been approved in the US to combat sleepiness
Included here are performance-enhancing surgery and medications--think of wavefront-guided laser lens sculpting for better than 20/20 vision or Provigil (modafinil), a memory enhancing drug used to combat fatigue.
The '516 patent covers the pharmaceutical compositions of the form of modafinil contained in PROVIGIL Tablets (C-IV) and does not expire until 2014.