Home Drug Guide Safinamide Mesylate

Drug Guide

Generic Name

Safinamide Mesylate

Brand Names Xadago

Classification

Therapeutic: Parkinson's disease adjunct therapy

Pharmacological: Selective reversible MAO-B inhibitor

FDA Approved Indications

Treatment of Parkinson's disease as an add-on to levodopa/carbidopa therapy

Mechanism of Action

Inhibits monoamine oxidase B (MAO-B), increasing dopaminergic activity; also modulates glutamate release.

Dosage and Administration

Adult: Initially 50 mg once daily; can increase to 100 mg once daily if tolerated.

Pediatric: Not approved for pediatric use.

Geriatric: No specific dosage adjustment required, but caution advised due to possible comorbidities.

Renal Impairment: Use with caution; no specific dose adjustment recommended.

Hepatic Impairment: Use with caution; initiate at lower doses due to potential for increased plasma levels.

Pharmacokinetics

Absorption: Rapidly absorbed, bioavailability approximately 95%.

Distribution: Widely distributed; protein binding ~70%.

Metabolism: Metabolized mainly by amide hydrolysis, minor oxidative pathways.

Excretion: Primarily renal excretion of metabolites, with some fecal excretion.

Half Life: Approximately 20 hours.

Contraindications

Use with other MAO inhibitors or within 14 days of discontinuing MAO inhibitors.
Known hypersensitivity.

Precautions

Risk of serotonin syndrome when combined with other serotonergic medications.
Monitor for impulsive or compulsive behaviors.
Caution in patients with hepatic impairment; may need dose adjustments.

Adverse Reactions - Common

Dyskinesia (Common)
Nausea (Common)
Fall (Common)
Insomnia (Common)

Adverse Reactions - Serious

Serotonin syndrome (Uncommon)
Hypersensitivity reactions including angioedema (Rare)
Hallucinations or psychosis (Rare)

Drug-Drug Interactions

Other serotonergic agents (SSRIs, SNRIs, triptans), other MAO inhibitors, dopamine agonists.

Drug-Food Interactions

Moderate alcohol intake may increase adverse effects.

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of dyskinesia, serotonin syndrome, and behavioral changes.

Diagnoses:

Risk for injury due to fall or dyskinesia.
Risk for serotonin syndrome.

Implementation: Administer as per prescribed dose; monitor for adverse effects.

Evaluation: Assess for Improvement in motor symptoms and monitor for adverse reactions.

Patient/Family Teaching

Take medication exactly as prescribed.
Avoid concurrent use of other serotonergic drugs without medical advice.
Report any unusual changes in mood, behavior, or new onset of involuntary movements.
Limit alcohol intake.

Special Considerations

Black Box Warnings:

Serotonin syndrome risk when combined with other serotonergic agents.

Genetic Factors: Limited data available.

Lab Test Interference: None noted.

Overdose Management

Signs/Symptoms: Altered mental status, hyperthermia, hypertension, tachycardia, agitation, seizures.

Treatment: Supportive care, intravenous fluids, monitoring vital signs, and managing symptoms; no specific antidote.

Storage and Handling

Storage: Store at room temperature away from light and moisture.

Stability: Stable under recommended storage conditions for the duration of its shelf life.