What Is ZELAPAR?
ZELAPAR is a once-daily form of a medicine called selegiline that offers many patients with Parkinson's disease more active hours. What makes ZELAPAR tablets unique is that they are orally disintegrating, meaning a tablet dissolves within seconds after being placed in the mouth. This makes ZELAPAR easy to take and allows ZELAPAR to deliver more active drug at a lower dose than the swallowed pill formulations.
In clinical studies, ZELAPAR, on average, provided 2.2 hours less OFF time per day and 1.8 hours more dyskinesia-free ON time compared with baseline (before starting ZELAPAR). People who did not add ZELAPAR to their usual treatment had, on average, 0.6 fewer OFF hours and 0.4 more ON hours daily over the same time period.
How is ZELAPAR different from conventional-tablet selegiline?
ZELAPAR was developed to increase the predictability and speed of absorption. Unlike conventional selegiline, ZELAPAR goes through the lining of the mouth right into the bloodstream, where it starts to work. Below is a chart that summarizes the differences between conventional selegiline and ZELAPAR.
IMPORTANT SAFETY INFORMATION
Zelapar is added to levodopa/carbidopa treatment of Parkinson’s disease in patients who are experiencing a reduced response to this therapy. There is no evidence from clinical studies that Zelapar provides any benefit if used without levodopa therapy.
Important Safety Information
Zelapar should not be taken by patients who are allergic to selegiline or any of the ingredients in Zelapar. Zelapar should not be taken along with certain other medications, including:
Zelapar is not usually recommended in combination with antidepressant medications such as tricyclic antidepressants, serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Be sure to discuss with your doctor any medication you are taking.
Do not take more than 2 tablets of Zelapar a day (2.5 mg) because of rare cases of high blood pressure reported when conventional selegiline tablets were taken along with foods containing tyramine.
In clinical studies, cases of low blood pressure were higher in elderly patients taking Zelapar than in patients taking placebo (a sugar pill), but this was not seen in nonelderly patients. Zelapar may increase some side effects of levodopa and may cause or worsen dyskinesia. Lowering the dose of levodopa may reduce this side effect. Tell your doctor if you are pregnant or may become pregnant, because Zelapar is used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
The most common side effects reported in clinical studies were dizziness, nausea, pain, headache, sleeplessness, runny nose, dyskinesia, back pain, soreness in the mouth or throat, and indigestion.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 800.FDA.1088.
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