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 the 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 in 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).
Please see accompanying
complete prescribing information. |