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.
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