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Alertec (CA), Apo-Mofafinil (CA), Provigil
Pharmacologic class: Nonamphetamine CNS stimulant
Therapeutic class: Analeptic
Controlled substance schedule IV
Pregnancy risk category C
Unknown. Thought to stimulate CNS by decreasing the release of gamma-aminobutyric acid (a CNS depressant), thereby increasing mental alertness.
Tablets: 100 mg, 200 mg
⊘Indications and dosages
Adults: 200 mg/day P.O. as a single dose in morning
• Severe hepatic impairment
• Hypersensitivity to drug
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).
• Give without food (food delays drug absorption).
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
Musculoskeletal: joint disorders, neck pain and rigidity
Respiratory: lung disorder, dyspnea, asthma
Skin: dry skin
Other: fever, chills, herpes simplex infection
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
• 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.)
• 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.