INDICATIONS AND USAGE（适应症）

XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.

DOSAGE（服用剂量）

The recommended starting dosage of XADAGO is 50 mg administered orally once daily (at the same time of day), without regard to meals. After two weeks, the dosage may be increased to 100 mg once daily, based on individual need and tolerability.

Daily dosages of XADAGO above 100 mg have not been shown to provide additional benefit, and higher dosages increase the risk for adverse reactions. XADAGO has been shown to be effective only in combination with levodopa/carbidopa.

If a dose is missed, the next dose should be taken at the same time the next day.

XADAGO 100 mg should be tapered by decreasing the dose to 50 mg for one week before stopping.

ADVERSE REACTIONS（不良反应）

Hypertension

Serotonin Syndrome

Falling Asleep During Activities of Daily Living

Dyskinesia

Hallucinations / Psychotic Behavior

Impulse Control / Compulsive Behaviors

Withdrawal-Emergent Hyperpyrexia and Confusion

Retinal Pathology

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/c4d65f28-983f-42b4-bb23-023ae0fe81b2/spl-doc?hl=Safinamide

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