Safinamide Dosage

Medically reviewed by Drugs.com. Last updated on Sep 1, 2023.

Usual Adult Dose for Parkinson's Disease

Initial dose: 50 mg orally once a day
Maintenance dose: After 2 weeks, may increase dose to 100 mg orally once a day based on individual need and tolerability
Maximum dose: 100 mg per day

Comment:

• Higher doses have not been shown to provide additional benefit while they do increase the risk for adverse reactions.
• This drug has only been shown effective in combination with levodopa/carbidopa.

Use: As adjunctive treatment to levodopa/carbidopa in patients with PD experiencing "off" episodes.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Moderate hepatic impairment (Child-Pugh B: 7 to 9): Maximum dose: 50 mg orally once a day
Severe hepatic impairment (Child-Pugh C: 10 to 15): Contraindicated

Patients who progress from moderate to severe hepatic impairment should discontinue therapy.

Dose Adjustments

Discontinuation:

• Decrease dose to 50 mg orally once a day for 1 week before stopping.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to this drug; reactions have included swelling of the tongue and oral mucosa, and dyspnea
• Severe hepatic impairment (Child-Pugh C: 10 to 15)
• Concomitant use with monoamine oxidase inhibitors (MAOI) or other drugs that are potent inhibitors of monoamine oxidase, including linezolid; the combination may result in increased blood pressure, including hypertensive crisis
• Concomitant use with dextromethorphan; the combination of MAOIs with dextromethorphan has been reported to cause episodes of psychosis or abnormal behavior
• Concomitant use of opioid drugs (e.g. meperidine and its derivatives, methadone, propoxyphene, or tramadol); serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic, tetracyclic, or triazolopyridine antidepressants; cyclobenzaprine; methylphenidate, amphetamine, and their derivatives; or St John's wort. Concomitant use may result in life-threatening serotonin syndrome

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally once a day at the same time of day
• May take with or without food
• If a dose is missed, take the next dose at the same time the next day

General:

• Efficacy of this drug is dependent on combination use with levodopa; clinical trials have shown patients receiving this drug in combination with levodopa had longer durations of, and more beneficial "on" time as evidenced by improved motor function scores during these times.

Monitoring:

• Monitor for new onset or worsening hypertension
• Monitor for visual changes, especially in patients with a history of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, or any active retinopathy.
• Monitor for impulse control disorders
• Monitor for dopaminergic side effects; dose adjustment of levodopa dose may be necessary
• Monitor for serotonin syndrome in patients concomitantly receiving SSRIs

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
• Patients should be instructed to talk to their healthcare provider when considering adding any new medications including over the counter medications as there are potentially dangerous interactions; patients should be advised to avoid foods that contain large amounts of tyramine.
• Patients should be instructed to contact their healthcare provider if they experience blood pressure elevations, hallucinations, psychotic behavior, impulse control or compulsive behaviors as they may be attributed to use of this drug.
• Patients should be aware that increased dyskinesias are possible and they should contact their healthcare professional as medication adjustments may be necessary.
• Patients who are pregnant, breastfeeding, or planning to have a baby should discuss this with their doctor before taking this medication; women of childbearing potential should not be given this drug unless adequate contraception is practiced.
• Patients should be advised of the potential sedating effects of this drug; they should not drive or operate hazardous machinery until they have gained sufficient experience taking this drug.
• Patients should be advised of the possibility of falling asleep while engaged in activities of daily living (ADL), including driving; if they experience an episode of falling asleep during ADLs, they should not drive or participate in potentially dangerous activities until they have consulted with their healthcare provider.
• Patients should be advised that this drug should not be stopped abruptly.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer