Zelapar®
Indication
Zelapar® (selegiline hydrochloride) is indicated as an adjunct in the management of patients with Parkinson's disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that Zelapar® has any beneficial effect in the absence of concurrent levodopa therapy.
Product Description
Zelapar® is a special once-daily formulation of the drug selegiline that adds more active hours to the lives of people with Parkinson's disease (PD). Doctors may recommend adding once-daily Zelapar® to patients' current levodopa/carbidopa medication if they are having a reduced response to this therapy. Studies have shown that adding Zelapar® reduces OFF time by about 2 hours per day.
Product Availability
- United States
Important Safety Information
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 should not be administered with the analgesic agents tramadol, methadone, and propoxyphene. Zelapar® should not be used with antitussive agent dextromethorphan and should not be administered along with other selegiline products. Daily doses of Zelapar® should not exceed 2.5 mg/day because of the risks associated with nonselective inhibition of MAO. In general, the combination of Zelapar® and tricyclic antidepressants, as well as Zelapar® and serotonin reuptake inhibitors, should be avoided. In clinical trials, the incidence of adverse orthostatic hypotension was higher in geriatric patients than the nongeriatric 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.
The most commonly observed adverse events reported during clinical trials were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, skin disorders, stomatitis, and dyspepsia. In addition, 5.2% of patients discontinued Zelapar® therapy due to adverse events (versus 1% with placebo).