Finapark(Safinamide tablet)

Therapeutic Group: Others

Presentation

Finapark TM 50: Each tablet contains Safinamide Mesylate INN equivalent to Safinamide 50 mg.

FinaparkTM100: Each tablet contains Safinamide Mesylate INN equivalent to Safinamide 100 mg.

Description

The precise mechanism by which Safinamide exerts its effect in Parkinson’s disease is unknown. Safinamide inhibits the monoamine oxidase B (MAO-B) activity, by blocking the catabolism of dopamine, is thought to result in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain.

Indications

Safinamide is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. Safinamide has not been shown to be effective as monotherapy for the treatment of Parkinson’s disease.

Dosage & Administration

For Usual Initial Dosage:
The recommended starting dosage of Safinamide tablet is 50 mg orally once daily (at the same time of day). If a dose is missed, the next dose should be taken at the same time the next day.
For Maintenance dosage:
After 2 weeks, the dose may be increased to 100 mg once daily, based on individual need and tolerability. Safinamide 100 mg should be tapered by decreasing the dose to 50 mg for one week before stopping.

Side Effects

Most common adverse reactions of Safinamide’s are dyskinesia, fall, nausea, and insomnia.

Precautions

Patients may experience hypertension, serotonin syndrome when used with MAO inhibitors, antidepressants and opioid drugs.

Use in Pregnancy & Lactation

Pregnancy:
Pregnancy Category C.
Lactation:
It is not known whether Safinamide is present in human milk. Caution should be exercised when administered to a nursing woman.
Use in Children:
Safety & effectiveness of Safinamide in infants & children have not been established.

Drug Interaction

Concomitant use with MAO inhibitors, antidepressants or opioid drugs and dextromethorphan.

Over Dose

There is no human experience with Safinamide overdose. If an important overdose occurs, Safinamide treatment should be discontinued and supportive treatment should be administered as clinically indicated along with dietary restriction of tyramine for several weeks.

Storage

Do not store above 30C. Keep away from light and out of the reach of children.

Commercial Pack

FinaparkTM 50: Each box contains 3 blister strips of 10 tablets.
FinaparkTM 100: Each box contains 3 blister strips of 10 tablets.