zelapar (selegiline HCl) Orally Disintegrating Tablets
Healthcare Professionals
For Healthcare Professionals
 
 
 
 
Efficacy

Add Zelapar® (selegiline HCl) to levodopa/carbidopa for MORE.

Zelapar is an important new addition to the PD armamentarium.”

Zelapar is an effective, well-tolerated adjunctive therapy for Parkinson’s disease patients being treated with levodopa/carbidopa whose response to this therapy is deteriorating. Its new, orally disintegrating formulation utilizes an advanced Zydis® delivery technology that delivers more active drug to the brain compared to conventional selegiline. Patients may experience a reduction of up to 80%–90% in amphetamine-like metabolites.

 

Zelapar significantly reduces OFF time in as early as 1 week

OFF time decreased even further...

  • Within 2 weeks of increasing the Zelapar dose to 2.5 mg
  • During the final 2 weeks of the study

Zelapar reduced OFF time by 2.2 hours per day

45% of Parkinson's disease (PD) patients experience motor fluctuations (wearing off) during the second year of levodopa/carbidopa (L–dopa) therapy

Many patients experience dyskinesia with L–dopa therapy.
• 25% after 13 to 24 months, nearly 40% by years 4 to 6

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