Applies to the following strength(s): 50 mg ; 100 mg
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Usual Adult Dose for:
Additional dosage information:
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
-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.
-Decrease dose to 50 mg orally once a day for 1 week before stopping.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-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
-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.
-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
-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.
More about safinamide
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- Drug class: dopaminergic antiparkinsonism agents
Other brands: Xadago