Safinamide Application Scope

Safinamide 50mg (brand name Xadago) is a reversible monoamine oxidase-B (MAO-B) inhibitor primarily used as an adjunctive treatment for Parkinson’s disease (PD) in patients experiencing “off” episodes.

It is indicated for use in combination with levodopa/carbidopa to manage motor fluctuations in mid- to late-stage PD.

Safinamide tablets have both dopaminergic and non-dopaminergic effects, including inhibition of glutamate release, which may provide additional benefits in managing PD symptoms.

Safinamide Characteristics

Ingredients:

Active ingredient: Safinamide mesylate.

Properties:

Molecular formula: C17H19FN2O2
Molecular weight: 302.349 g/mol
Appearance: White to off-white film-coated tablets.

Specification:

Tablet strengths: 50 mg and 100 mg.

Packaging Specification:

Available in blister packs or bottles, typically containing 30 tablets.

Storage:

Store at room temperature (15°C to 30°C or 59°F to 86°F). Protect from moisture and light.

Expiry Date:

Typically 24-36 months from the date of manufacture, as indicated on the packaging.

Executive Standard:

Complies with international pharmacopeial standards (e.g., USP, EP).

Approval Number:

Varies by region (e.g., FDA NDA 207145 for the US, EMA approval for the EU).

Date of Revision:

Refer to the latest package insert or regulatory updates for specific revision dates.

Manufacturer:

Zambon Italia S.R.L. (EU), US WorldMeds LLC (US), and other licensed manufacturers globally.

Guidelines For The Use Of Safinamide

Dosage and Administration:

Initial dose: 50 mg once daily, taken at the same time each day.
After 2 weeks, the dose may be increased to 100 mg once daily based on patient tolerance and clinical response.
Administered orally with or without food.

Adverse Reactions:

Common side effects: Uncontrolled movements (dyskinesia), falls, nausea, insomnia.
Serious side effects: Hypertension, serotonin syndrome, hallucinations, retinal changes, and impulse control disorders.

Contraindications:

Severe liver impairment (Child-Pugh C).
Concurrent use of other MAO inhibitors, opioids (e.g., tramadol), dextromethorphan, or certain antidepressants.
History of hypersensitivity to safinamide.

Precautions:

Monitor blood pressure regularly.
Avoid high-tyramine foods (e.g., aged cheeses, cured meats) to prevent hypertensive crises.
Use with caution in patients with a history of retinal disorders or impulse control issues.

Safinamide Interactions

Drug Interactions:

MAO Inhibitors: Risk of hypertensive crisis.
Opioids (e.g., tramadol): Risk of serotonin syndrome.
Dextromethorphan: May cause psychosis or abnormal behavior.
SSRIs/SNRIs: Increased risk of serotonin syndrome.
Tyramine-rich foods: Potential for severe hypertension.

Food Interactions:

Avoid high-tyramine foods and excessive alcohol consumption

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong DengYue Medicine. It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.