Names and pronunciation
(mo-daf′i-nil) Alertec , Provigil
PDF page 907
Loading InternPractice…
Drug reference
(mo-daf′i-nil) Alertec , Provigil
PDF page 907
Func. class.: CNS stimulant
PDF page 907
Chem. class.: Racemic compound Controlled Substance Schedule IV
PDF page 907
ACTION: Similar action as that of sympathomimetics; does not alter release of DOPamine, norepinephrine
PDF page 907
USES: Narcolepsy, shift-work sleep disturbance, obstructive sleep apnea
PDF page 907
Unlabeled uses: ADHD, fatigue in MS, Parkinson’s disease
PDF page 907
CONTRAINDICATIONS: Hyper- sensitivity, ischemic heart disease, left ventricular hypertrophy, chest pain, dysrhythmias Precautions: Pregnancy, breastfeeding, child <16 yr, geriatric patients, unstable angina, history of MI, severe hepatic disease
PDF page 907
SIDE EFFECTS CNS: Headache, anxiety, cataplexy, depression, dizziness, insomnia, amnesia, confusion, ataxia, tremors, paresthesia, dyskinesia, suicidal ideation CV: Dysrhythmias, hypo/hypertension, chest pain, vasodilation EENT: Change in vision, rhinitis, pharyn- gitis, epistaxis GI: Nausea, vomiting, changes in LFTs, anorexia, diarrhea, thirst, mouth ulcers GU: Ejaculation disorder, urinary reten- tion, albuminuria HEMA: Eosinophilia INTEG: Rash, dry skin, herpes simplex, Stevens-Johnson syndrome MISC: Infection, hyperglycemia, neck pain RESP: Dyspnea, lung changes
PDF page 907
INTERACTIONS Increase: altered levels of CYP3A4 inhibitors (azole antibiotics, some SSRIs); reaction difficult to predict; monitor for reaction Increase: levels of CYP2C19 substrates (diazePAM, phenytoin, some tricyclics), adjust dose if needed Decrease: effects of—cycloSPORINE, hormonal contraceptives, theophylline, estrogens Delayed effect modafinil by 1 hr: methylphenidate Altered: levels of CYP3A4 inducers (car- BAMazepine, phenytoin, rifAMPin, cyclo- SPORINE, theophylline) Drug/Herb Increase: stimulation—cola nut, gua- rana, yerba maté, coffee, tea Drug/Lab Test Increase: LFTs, glucose, eosinophils
PDF page 908
DOSAGE AND ROUTES To improve wakefulness with daytime sleepiness • Adult/adolescent ≥17 yr: PO 200 mg daily Hepatic dose (severe hepatic disease) • Adult: PO 100 mg daily
PDF page 907
Available forms: Tabs 100, 200 mg M
PDF page 907
Administer: • Give 1 hr before start of shift work or in AM for those with narcolepsy or sleep apnea • Store at room temperature • Give without regard to food
PDF page 907
Assess: • Narcolepsy, shift work, history of sleep apnea • Stevens-Johnson syndrome: rash, fever, fatigue, blisters; discontinue imme- diately if these occur; provide supportive therapy • Depression, suicidal ideation • Monitor B/P in those with hypertension • Pregnancy/breastfeeding: pregnant pa- tients should enroll in the pregnancy regis- try, 1-866-404-4106; use only when bene- fits outweigh risk to the fetus; avoid use in breastfeeding • Beers: avoid in older adults; CNS stim- ulant effects
PDF page 908
Evaluate: • Ability to stay awake
PDF page 908
CLINICAL CONSIDERATIONS
PDF page 908
Patient and caregiver information: • To take only as directed; that product may be taken with/without food • To use other form of contraception dur- ing and for ≥30 days after discontinuing medication if using hormonal birth con- trol; to notify prescriber if pregnancy is planned or suspected or if breastfeeding • To notify prescriber of allergic reaction, tremors, confusion, trouble breathing • To avoid all OTC medications unless approved by prescriber; not to use alcohol • To avoid hazardous activities until drug effect is known
PDF page 908
PHARMACOKINETICS Absorbed rapidly, 60% protein binding, metabolized by the liver (90%), half-life 15 hr, peak 2-4 hr
PDF page 908
• Adult/adolescent ≥17 yr: PO 200 mg daily Hepatic dose (severe hepatic disease)
PDF page 907