zelapar (selegiline HCl) Orally Disintegrating Tablets
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Is Zelapar Right for Your Patients?

Wearing off can begin early in therapy, with data demonstrating that more than 25% of patients experienced dyskinesias after 13 to 24 months of levodopa/carbidopa therapy. By years 4 to 6, this number increased to nearly 40%.

One approach to clinical management of wearing off has been to increase levodopa/carbidopa dose or frequency, however, increasing the levodopa/carbidopa dose can increase complications. Results of a 42-week study published in the New England Journal of Medicine in December, 2004 demonstrated that OFF time and dyskinesias increased at significant (600/150 mg/day) levodopa/carbidopa doses.

Adding Zelapar® (selegiline HCl) as an adjunctive therapy boosts the action of levodopa/carbidopa. Zelapar reduces OFF time by 2.2 hours per day.

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 dopaminergic effects that can usually be managed by decreasing the levodopa dose.

Selegiline produces 3 major metabolites, including amphetamine and methamphetamine. The effects of these metabolites are not known; however, they have been associated with properties such as neurotoxicity and cardiovascular toxicity. Importantly, the unique delivery system of Zelapar has been shown to produce an 80% – 90% reduction in plasma levels of amphetamine-like metabolites compared to conventional selegiline oral tablets (10 mg).

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.
Valeant Pharmaceuticals