Finapark 100

Indications

Finapark is a monoamine oxidase B (MAO-B) inhibitor used as an adjunct to levodopa/carbidopa therapy in patients with Parkinson’s disease who experience “off” episodes. It is not effective as a standalone treatment for Parkinson’s disease.

Always use under the supervision of a registered healthcare provider.

Pharmacology

The exact mechanism of action of Safinamide Mesylate in Parkinson’s disease is not fully understood. As a selective MAO-B inhibitor, it prevents the breakdown of dopamine, thereby increasing dopamine levels and enhancing dopaminergic activity in the brain.

Dosage & Administration

• Initial Dosage: The starting dose is 50 mg once daily, preferably at the same time each day.
• Maintenance Dosage: After 2 weeks, the dose may be increased to 100 mg daily, depending on the patient’s response and tolerance.
• Tapering: If discontinuing Safinamide, reduce the dose to 50 mg for one week before stopping.

Use in Special Populations:

• Children: Safety and effectiveness in pediatric patients have not been established.
• Geriatric Use: No significant differences in safety or efficacy between older and younger patients.
• Hepatic Impairment: Safinamide concentrations may increase in patients with liver impairment.

Interactions

• Selective Serotonin Reuptake Inhibitors (SSRIs): Risk of serotonin syndrome, monitor patients carefully.
• Sympathomimetic Medications: Increased risk of hypertension.
• Tyramine-rich Foods: Risk of severe hypertension.
• BCRP Substrates: Potential for increased plasma concentration of BCRP substrates.

Contraindications

• Monoamine Oxidase Inhibitors (MAOIs): Do not use with other MAO inhibitors or potent MAO inhibitors like linezolid.
• Opioid Drugs and Other Medications: Contraindicated with opioids (e.g., tramadol), tricyclic antidepressants, certain stimulants (e.g., methylphenidate, amphetamines), and St. John’s Wort.
• History of Hypersensitivity: Do not use in patients with a history of hypersensitivity to Safinamide.
• Severe Hepatic Impairment: Contraindicated in patients with severe liver damage (Child-Pugh C).

Side Effects

Common side effects include dyskinesia, falls, nausea, and insomnia. Rare but serious side effects may involve severe mood changes or hallucinations.

Pregnancy & Lactation

• Pregnancy: Category C. No well-controlled studies have been conducted in pregnant women. Animal studies have shown developmental toxicity, including teratogenic effects.
• Lactation: The safety of Safinamide in breastfeeding is unknown. It is excreted in animal milk and could potentially affect the infant.

Precautions & Warnings

• Hypertension: May cause or worsen high blood pressure.
• Serotonin Syndrome: Monitor patients for serotonin syndrome when used with other serotonergic drugs.
• Dyskinesia: Can exacerbate dyskinesia, consider reducing levodopa dosage.
• Behavioral Changes: May lead to hallucinations, psychosis, or compulsive behaviors.
• Sleepiness: May cause excessive drowsiness during daily activities.

Overdose Effects

While human data is limited, overdose may lead to symptoms such as acute dystonia, hypotension, confusion, and sweating. In case of overdose, discontinue Safinamide and provide supportive care. Avoid tyramine-containing foods for several weeks.

Therapeutic Class

• Antiparkinson drugs

Storage Conditions

Store below 30°C. Protect from light and moisture. Keep out of the reach of children.