Meiji Seika




Concise Prescribing Info
Safinamide mesilate
Improvement of wearing-off phenomenon in Parkinson's disease currently treated w/ levodopa-containing products.
Dosage/Direction for Use
Adult 50 mg orally once daily in combination w/ levodopa-containing products. May be administered at 100 mg once daily according to the patient's condition.
May be taken with or without food.
Hypersensitivity. Patients using other MAOI (eg, selegiline HCl, rasagiline mesilate); pethidine HCl-containing products, tramadol HCl-containing products, or tapentadol HCl; TCAs (eg, amitriptyline HCl, amoxapine, imipramine HCl, clomipramine HCl, dosulepin HCl, trimipramine maleate, nortriptyline HCl, lofepramine HCl), TeCA (eg, maprotiline HCl, mianserin HCl, setiptiline maleate), SSRIs (eg, fluvoxamine maleate, paroxetine HCl hydrate, sertraline HCl, escitalopram oxalate), SNRI (eg, milnacipran HCl, duloxetine HCl, venlafaxine HCl), selective noradrenaline reuptake inhibitor (atomoxetine HCl), noradrenergic & serotonergic antidepressant (mirtazapine), or CNS stimulants (eg, methylphenidate HCl, lisdexamfetamine mesilate). Severe hepatic impairment (Child-Pugh C). Pregnancy or women suspected being pregnant.
Special Precautions
Should not exceed 50 mg daily for patients w/ moderate hepatic impairment (Child-Pugh B). Co-administration w/ levodopa-containing products may cause adverse reactions of levodopa origin (eg, dyskinesia). Regularly monitor for any change in acuity- & field-related symptoms of patients w/ retinal degeneration, uveitis, hereditary retinopathy, or severe progressive diabetic retinopathy, history of eye disorders that are highly likely to affect the retina (eg, retinitis pigmentosa, any form of active retinopathy, family history of hereditary retinal disease), and albinism. May induce impulse-control disorder eg, pathological gambling (persistent repetition of gambling despite socially adverse consequences including disruption of personal life), pathological hypersexuality, compulsive shopping, & hyperphagia; orthostatic hypotension or hypotension. Patients w/ complication or history of diseases, active or a history of retina-related disease. If the press-through package (PTP) is swallowed, it may cause perforation of the punctured esophageal mucosa due to the sharp corners of the sheet, resulting in severe complications including mediastinitis. Not to be administered w/ severe hepatic impairment (Child-Pugh C). Caution patients against engaging in dangerous activities (eg, driving a car, operating machinery, or working at heights. Women of childbearing potential to use appropriate contraception during treatment & for a certain period of time after the completion of treatment. Not to be used during pregnancy & lactation. Childn.
Adverse Reactions
Visual hallucinations, hallucination; daytime somnolence or sudden onset of sleep w/ no signs; impulse-control disorder including pathological gambling & hypersexuality, compulsive shopping or hyperphagia; serotonin syndrome (eg, anxiety, restlessness, excitement, confusion, fever, myoclonus, sweating, & tachycardia); rapid dose reduction/discontinuation may cause high fever, consciousness disorder, severe muscle rigidity, involuntary movement, increased serum CK.
Drug Interactions
May induce additive effect w/ MAOIs; additive or synergistic effects w/ TCA, tetracyclic antidepressants. May increase serotonin reuptake w/ SSRIs; may increase monoamine w/ serotonin-noradrenaline reuptake inhibitors & NRIs; enhanced neurotransmission w/ noradrenergic & serotonergic antidepressant; may increase total amount of CNS stimulants. May increase brain serotonin conc w/ trazodone HCl & dextromethorphan HBr hydrate. Reduced brain dopamine w/ reserpine derivative (eg, reserpine), phenothiazines (eg, chlorpromazine), butyrophenones (eg, haloperidol), sulpiride, & metoclopramide. Induced additive effect w/ linezolid. Enhanced sympathomimetic effect w/ sympathomimetic agents (eg, ephedrine HCl, methylephedrine HCl, pseudoephedrine HCl-containing drugs, phenylpropanolamine-containing drugs).
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BD03 - safinamide ; Belongs to the class of dopaminergic agents, monoamine oxidase B inhibitors. Used in the management of Parkinson's disease.
Equfina FC tab 50 mg
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