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Safety and Tolerability
Zelapar® (selegiline HCl) demonstrates
excellent safety and tolerability.
Zelapar is well tolerated. The most commonly observed adverse effects include nausea, dizziness, pain, headache, insomnia, rhinitis, dyskinesia, skin disorders, stomatitis, back pain and dyspepsia.
- When combined with levodopa/carbidopa, selegiline may be associated
with dopamingeric effects that can usually be managed by reducing the
levodopa dose.
- There is minimal risk of clinically relevant MAO-A inhibition or tyramine pressor responses at recommended doses
- No hypertensive events reported
- Orthostatic hypotensive events were comparable to placebo + L-dopa
- 80–90% reduction in amphetamine metabolites with Zelapar versus 10 mg conventional selegiline oral tablets
- Incidence of abnormal dreams, somnolence, insomnia, confused or abnormal thinking, amnesia, and paranoid reactions comparable to placebo + L–dopa (incidence ≤ 1.2%)
- Rare cases of hypertensive crisis have been reported with the use of conventional oral selegiline, even at the recommended dose.
» Full Prescribing Information |
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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. |
| Zydis® is a registered trademark of R.P.
Scherer Corporation. |
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