Concise Prescribing Info
Adults w/ idiopathic Parkinson’s disease (PD) for improvement of wearing-off phenomenon as add-on therapy to a stable dose of l-dopa alone or in combination w/ other PD medicinal products in late-stage PD.
Dosage/Direction for Use
Adult 50 mg orally once daily in combination w/ l-dopa-containing products. May be administered at 100 mg once daily according to the patient's condition. Moderate hepatic impairment (Child-Pugh B) Max: 50 mg daily.
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), tetracyclic antidepressants (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
Discontinue use in patients observed w/ impulse-control disorder eg, pathological gambling (persistent repetition of gambling despite socially adverse consequences including disruption of personal life), pathological hypersexuality, compulsive shopping & hyperphagia; dizziness, lightheadedness, wobble, or any other symptoms which are suspected orthostatic hypotension or hypotension. Monitor 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), & albinism for any change in acuity- & field-related symptoms. Caution patients against engaging in dangerous activities eg, driving a car, operating machinery, or working at heights. Not to be administered in patients w/ severe hepatic impairment (Child-Pugh C). Increased blood conc in patients w/ moderate hepatic impairment (Child-Pugh B). Women of childbearing potential should use appropriate contraception during treatment & for a certain period of time after completion. Not to be used in pregnant women or women who may possibly be pregnant. Breastfeeding should be discontinued during treatment. 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. Dyskinesia; insomnia, headache, dizziness; nausea, constipation; fall; increased ALT.
Drug Interactions
May induce additive effect w/ MAOIs; additive or synergistic effects w/ TCA, tetracyclic antidepressants. May increase brain serotonin conc w/ SSRIs; total amount of monoamine in the brain w/ SNRIs. Enhanced neurotransmission w/ noradrenergic & serotonergic antidepressant. Possible serious AR including hypertensive crisis w/ 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. May induce additive effect w/ linezolid. Possible 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
2 × 14's
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