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Equfina

Equfina

safinamide

Manufacturer:

Eisai

Distributor:

DKSH
Concise Prescribing Info
Contents
Safinamide mesilate
Indications/Uses
Improvement of wearing-off phenomenon in Parkinson's disease currently treated w/ l-dopa-containing products.
Dosage/Direction for Use
Adult 50 mg once daily. May be administered at 100 mg once daily according to the patient's condition. Moderate hepatic impairment (Child-Pugh B) Max: 50 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ other MAOIs; pethidine- & tramadol HCl-containing products or tapentadol HCl; TCAs, tetracyclic antidepressants, SSRIs, SNRIs, noradrenergic & serotonergic antidepressant or CNS stimulants. Severe hepatic impairment (Child-Pugh C). Pregnancy or women suspected of being pregnant.
Special Precautions
Discontinue use if dizziness, lightheadedness, wobble or any other orthostatic hypotension or hypotension suspected symptoms are observed. May induce daytime somnolence or sudden sleep onset w/o signs; impulse-control disorder; orthostatic hypotension or hypotension. 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 affecting retina (eg, retinitis pigmentosa, active retinopathy, family history of hereditary retinal disease) & albinism. May affect ability to drive & use machines. Not to be used in severe hepatic impairment. Moderate hepatic impairment (Child-Pugh B). Women of childbearing potential must use effective contraception. Not to be used during pregnancy & lactation. Childn.
Adverse Reactions
Dyskinesia. Visual hallucinations, hallucination; daytime somnolence, sudden sleep onset w/o signs; impulse-control disorder eg, pathological gambling & hypersexuality, compulsive shopping, hyperphagia. Insomnia, headache, dizziness; nausea, constipation; fall; increased ALT.
Drug Interactions
Additive effect w/ MAOIs (eg, selegiline HCl, rasagiline mesilate); linezolid. Possible serious adverse reactions including serotonin syndrome w/ pethidine- & tramadol HCl-containing products or tapentadol HCl. 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). Increased brain serotonin conc w/ SSRIs (eg, fluvoxamine maleate, paroxetine HCl hydrate, sertraline HCl, escitalopram oxalate); trazodone HCl. Increased brain monoamine total amount w/ SNRIs (eg, milnacipran HCl, duloxetine HCl, venlafaxine HCl), atomoxetine HCl; mirtazapine; CNS stimulants eg, methylphenidate HCl, lisdexamfetamine mesilate. Reduced effect w/ reserpine derivatives, phenothiazines, chlorpromazine, butyrophenones, haloperidol, sulpiride, metoclopramide. Serotonin syndrome w/ dextromethorphan HBr hydrate. Enhanced sympathomimetic effect of sympathomimetic agents eg, ephedrine HCl, methylephedrine HCl, pseudoephedrine HCl- & 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.
Presentation/Packing
Form
Equfina FC tab 50 mg
Packing/Price
28's
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