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Administration
May be taken with or without food.
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Contraindications
Uncontrolled moderate to severe hypertension, cardiac arrhythmias. Pregnancy.
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Special Precautions
Patients with history of psychiatric disorders (e.g. psychosis, depression, mania, major anxiety, agitation, insomnia), alcohol, drug or illicit substance abuse; CV disease (e.g. recent history of MI, unstable angina, coronary artery disease). Hepatic or renal impairment. Elderly. Lactation. Not recommended in patients with a history of left ventricular hypertrophy or cor pulmonale, and in patients with mitral valve prolapse induced by previous CNS stimulant use. Patient Counselling This drug may cause blurred vision or dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Perform ECG before initiation of therapy. Monitor blood pressure, heart rate, development of severe skin reactions or psychiatric symptoms.
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Adverse Reactions
Significant: Onset or worsening of anxiety, nervousness, insomnia, confusion, agitation, depression, suicide-related behaviour, psychotic or manic symptoms, aggressive or hostile behaviour, chest pain, palpitations, dyspnoea.
Cardiac disorders: Tachycardia.
Eye disorders: Blurred vision.
Gastrointestinal disorders: Abdominal pain, nausea, dry mouth, diarrhoea, dyspepsia, constipation.
General disorders and administration site conditions: Back pain.
Immune system disorders: Angioedema.
Investigations: Abnormal liver function test.
Metabolism and nutrition disorders: Decreased appetite.
Nervous system disorders: Headache, dizziness, paraesthesia.
Psychiatric disorders: Hallucinations, delusions, somnolence.
Respiratory, thoracic and mediastinal disorders: Rhinitis, pharyngitis.
Vascular disorders: Vasodilation, hypertension.
Potentially Fatal: Rarely, multi-organ hypersensitivity reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms. |
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C
Avoid using modafinil during pregnancy due to congenital malformations including increased risk of congenital cardiac anomalies
intrauterine growth restriction & spontaneous abortion.
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Drug Interactions
Altered plasma concentrations with CYP3A4 inducers (e.g. carbamazepine, phenobarbital, rifampicin) and CYP3A4 inhibitors (e.g. ketoconazole, itraconazole). Decreased clearance of phenytoin, warfarin, diazepam, propranolol, omeprazole. Reduced effectiveness of steroidal contraceptives.
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CIMS Class
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ATC Classification
N06BA07 - modafinil ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
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