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Prescribing Information
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IMPORTANT SAFETY INFORMATION
Indication
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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