Clinical Pharmacology Details


MODAFINIL


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Indications & Dose:

Excessive sleepiness associated with narcolepsy with or without cataplex 



Adult: Initially 200 mg daily in 2 divided doses, dose to be taken in the morning and at noon, alternatively initially 200 mg once daily, dose to be taken in the morning, adjusted according to response to 200–400 mg daily in 2 divided doses, alternatively adjusted according to response to 200–400 mg once daily


Elderly: Initially 100 mg daily

Contraindications:

Arrhythmia . history of clinically significant signs of CNS stimulantinduced mitral valve prolapse (including ischaemic ECG changes, chest pain and arrhythmias) . history of cor pulmonale . history of left ventricular hypertrophy . moderate uncontrolled hypertension . severe uncontrolled hypertension 

Side Effects:

CNS: Headache (50%), nervousness (8%), dizziness (5%), depression (4%), anxiety (4%), and insomnia (3%), delayed sleep; euphoria, motor excitation reported with 500 mg daily doses


CV: Minimal effects on blood pressure and pulse


GI: Hypersalivation, nausea (13%), diarrhea (8%), dry mouth (5%)

Cautions:

Precautions:

Cardiovascular disease (left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, mitral valve prolapse, recent myocardial infarction, unstable angina); elderly patients (possible dose reductions); history of emotional instability, drug abuse orpsychosis, hypertension (periodic monitoring is advised); severe hepatic disease (50% dose reduction); severe renal impairment; risk of pregnancy with concurrent oral contraceptives use 

Interaction:

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Adverse Effects:

Lactations:

Pregnancy category C

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: