Equfina Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Safinamide

Indications/Uses

Idiopathic Parkinson's disease in adults as add-on therapy to a stable dose of l-dopa alone or in combination w/ other Parkinson's disease medicinal products in mid- to late-stage fluctuating patients.

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Dosage/Direction for Use

Initially 50 mg daily, may be increased to 100 mg daily on the basis of individual clinical need. Patients w/ moderate hepatic impairment 50 mg daily.

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Overdosage

View Equfina overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Concomitant use w/ other MAOIs or pethidine. Patients w/ severe hepatic impairment, albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy.

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Warnings

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Special Precautions

Avoid concomitant use w/ fluoxetine or fluvoxamine. At least 7 days must elapse between safinamide discontinuation & treatment initiation w/ MAOIs or pethidine. Impulse control disorders (ICDs) can occur in patients treated w/ dopamine agonists &/or dopaminergic treatments. Some reports of ICDs have also been observed w/ other MAOIs. Safinamide has not been associated w/ any increase in ICDs. May potentiate l-dopa side effects & exacerbate existing dyskinesia. This effect was not seen when safinamide was used as an adjunct to dopamine agonists in early stage PD patients. Potential retinal effects in patients w/ ophthalmological history. Stop treatment in case patients progress from moderate to severe hepatic impairment. May affect ability to drive & use machines. Not recommended during pregnancy & in women of childbearing potential not using contraception. Not to be used during breastfeeding. Safety & efficacy have not been established in childn & adolescents <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Insomnia; dyskinesia, somnolence, dizziness, headache, Parkinson's disease; cataract; orthostatic hypotension; nausea; fall.

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Drug Interactions

Risk of non-selective MAO inhibition w/ other MAOIs (including moclobemide). Risk of serious adverse reactions w/ pethidine; fluoxetine, fluvoxamine, SSRIs, SNRIs, TCAs, tetracyclic antidepressants & MAOIs. Antidepressants may be used at the lowest doses necessary. Potential interaction w/ sympathomimetic medicinal products; dextromethorphan. Monitoring is recommended when co-administered w/ BCRP substrates (eg, rosuvastatin, pitavastatin, pravastatin, ciprofloxacin, MTX, topotecan, diclofenac or glyburide). Potential increased exposure of organic cation transporter 1 substrates w/ t_max similar to safinamide eg, metformin, aciclovir, ganciclovir.

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Caution For Usage

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Storage

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Description

View Equfina description for details of the chemical structure and excipients (inactive components).

Action

View Equfina mechanism of action for pharmacodynamics and pharmacokinetics details.

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.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Equfina FC tab 50 mg

Packing/Price

28's

Equfina

safinamide

Manufacturer:

Eisai

Distributor:

The Glory Medicina

DKSH

Marketer:

Eisai