Equfina

Safinamide

Improvement of wearing-off phenomenon in idiopathic Parkinson's disease currently treated w/ l-dopa-containing products.

Adult 50 mg once daily. May be administered at 100 mg once daily according to the patient's condition. Taper 100 mg to 50 mg for 1 wk before discontinuation. Moderate hepatic impairment Max 50 mg daily.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ other MAOIs (eg, selegiline HCl, rasagiline mesilate); pethidine HCl- & 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), SNRIs (eg, milnacipran HCl, duloxetine HCl, venlafaxine HCl), selective noradrenaline reuptake inhibitor (eg, atomoxetine HCl), serotonergic antidepressant (eg, mirtazapine), CNS stimulants (eg, methylphenidate HCl, lisdexamfetamine mesilate). Severe hepatic impairment (Child-Pugh C). Pregnancy or women suspected of being pregnant.

Closely monitor patients co-administered w/ l-dopa-containing products upon initiation of therapy or increase in dosing. May induce daytime somnolence or sudden onset of sleep w/o signs; impulse-control disorder (eg, pathological gambling & hypersexuality, compulsive shopping & hyperphagia); orthostatic hypotension or hypotension. Discontinue use if dizziness, lightheadedness, wobble or any other symptoms which are suspected orthostatic hypotension or hypotension are observed. Increased risk of falls associated w/ motor dysfunction & orthostatic hypotension in patients w/ Parkinson's disease; may experience fracture &/or trauma due to fall. Regularly monitor any change in acuity- & field-related symptoms in patients w/ retinal degeneration, uveitis, hereditary 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. Not to be used in patients w/ congenital short QT syndrome. May affect the ability to drive & operate machinery. Moderate hepatic impairment (Child-Pugh B). Women of childbearing potential should use appropriate contraception during & for a certain period of time after completion of treatment. Discontinue breastfeeding during treatment. Childn.

Visual hallucinations, hallucination; daytime somnolence or sudden onset of sleep w/o signs; impulse-control disorder. Dyskinesia; insomnia, headache, dizziness; nausea, constipation; fall; increased ALT.

May induce additive effect w/ MAOIs (eg, selegiline HCl, rasagiline mesilate). Possible serious AR including serotonin syndrome w/ pethidine HCl- & tramadol HCl-containing products or tapentadol HCl. Possible additive or synergistic effects w/ 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). May increase brain serotonin conc w/ SSRIs (eg, fluvoxamine maleate, paroxetine HCl hydrate, sertraline HCl, escitalopram oxalate); trazodone HCl. May increase total amount of monoamine in the brain w/ SNRIs (eg, milnacipran HCl, duloxetine HCl, venlafaxine HCl), atomoxetine HCl & mirtazapine. Possible serious AR including hypertensive crisis w/ CNS stimulants (eg, methylphenidate HCl, lisdexamfetamine mesilate). Effect may be reduced w/ reserpine derivatives, phenothiazines, chlorpromazine, butyrophenones, haloperidol, sulpiride & metoclopramide. Serotonin syndrome may occur w/ dextromethorphan HBr hydrate. Possible additive effect w/ linezolid. Possible enhanced sympathomimetic effect of sympathomimetic agents, ephedrine HCl, methylephedrine HCl, pseudoephedrine HCl- & phenylpropanolamine-containing drugs. Possible severe HTN w/ food containing high amount of tyramine (>150 mg).

Antiparkinsonian Drugs

N04BD03 - safinamide ; Belongs to the class of dopaminergic agents, monoamine oxidase B inhibitors. Used in the management of Parkinson's disease.

POM