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Contraindications
Albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy. Severe hepatic impairment (Child-Pugh class C). Concomitant use with or within 2 weeks of other MAOIs or other drugs that are potent inhibitors of monoamine oxidase (including linezolid), opioids, SNRIs, TCAs, tetracyclic or triazolopyridine antidepressants, cyclobenzaprine, or St. John's wort. Concomitant use with methylphenidate, amphetamine, and their derivatives, or dextromethorphan.
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Special Precautions
Patient with major psychotic disorder, other ophthalmic disorders. Avoid abrupt withdrawal. Moderate hepatic impairment (Child-Pugh class B). Pregnancy and lactation. Patient Counselling This drug may cause dizziness or falling asleep during activities that require full attention; if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood pressure (at baseline, periodically, and as needed); hepatic function. Assess for signs and symptoms of visual changes, serotonin syndrome, new-onset or worsening hypertension and dyskinesia.
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Adverse Reactions
Significant: New-onset or worsening hypertension, CNS depression, dyskinesia, impulse control disorders; withdrawal-emergent hyperpyrexia and confusion (upon abrupt discontinuation or interruption of therapy); retinal disorder.
Blood and lymphatic system disorders: Anaemia, leucopenia, RBC abnormality.
Cardiac disorders: Palpitations, tachycardia, sinus bradycardia, arrhythmia.
Ear and labyrinth disorders: Vertigo.
Eye disorders: Cataract.
Gastrointestinal disorders: Nausea, dyspepsia.
Injury, poisoning and procedural complications: Fall.
Investigations: Increased ALT or AST.
Metabolism and nutrition disorders: Decreased or increased appetite.
Nervous system disorders: Dizziness, headache.
Psychiatric disorders: Insomnia, depression, restlessness.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, rhinorrhoea.
Vascular disorders: Orthostatic hypotension.
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Drug Interactions
Increased risk of hypertension with isoniazid, sympathomimetic agents (including nasal, oral or ophthalmic decongestants). Concurrent use with antipsychotics or metoclopramide may decrease the effectiveness of safinamide. May increase plasma concentrations of BCRP substrates (e.g. methotrexate, irinotecan, topotecan, imatinib, rosuvastatin).
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CIMS Class
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ATC Classification
N04BD03 - safinamide ; NULL
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