INDICATION and IMPORTANT SAFETY INFORMATION
Indication
Zelapar is indicated as an adjunct therapy for Parkinson's disease patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this strategy. There is no evidence from controlled studies that Zelapar has any beneficial effect in the absence of concurrent levodopa therapy.
Important Safety Information
Contraindications
Zelapar is contraindicated in patients with a known hypersensitivity to any formulation of selegiline or any of the inactive ingredients of Zelapar. Zelapar is also contraindicated for use with meperidine and other selegiline products; at least 14 days should elapse between discontinuation of Zelapar and beginning these therapies. Zelapar should not be administered with the analgesic agents tramadol, methadone and propoxyphene, or with the antitussive agent dextromethorphan. In general, treatment with tricyclic antidepressants, SSRIs, and SNRIs should be avoided in combination with Zelapar.
Warnings
Daily doses of Zelapar should not exceed 2.5 mg/day because of the risks associated with nonselective inhibition of MAO.
In clinical trials, the incidence of adverse orthostatic hypotension was higher in geriatric patients but not in non-geriatric patients. Zelapar may potentiate the dopaminergic side effects of levodopa and may cause or worsen preexisting dyskinesia. Decreasing the dose of levodopa may improve this side effect. Zelapar should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Precautions
Zelapar may potentiate the dopaminergic side effects of levodopa and may cause or worsen preexisting dyskinesia. Decreasing the dose of levodopa may improve this side effect. Zelapar should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Adverse Reactions
The most common adverse events in controlled trials were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, stomatitis and dyspepsia.
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