HCP Selegiline Is Good

ZELAPAR^® (selegiline HCl) Orally Disintegrating Tablets deliver good bioavailability (80%), with consistent plasma levels of active drug¹

ZELAPAR is added to levodopa/carbidopa treatment of Parkinson's disease in patients who are experiencing a reduced response to this therapy. There is no evidence from clinical studies that ZELAPAR provides any benefit if used without levodopa therapy.

ZELAPAR: More GOOD Can Make a Difference

Two studies of patients switching from conventional selegiline to ZELAPAR found:

Patients switched to 1.25 mg of ZELAPAR (n=64) experienced a small but significant improvement in UPDRS* scores: -3.0 point mean decline from baseline (P=.01); among those continuing with 10 mg of conventional selegiline (n=68), scores decreased a mean -0.5 points²
UPDRS part II ON scores moderately but significantly improved (P=.006) in an open-label study after patients switched to ZELAPAR^† (N=48); the total mean improvement in the scores was 1.3 points³
In each study, most patients preferred ZELAPAR^2,3

ZELAPAR: Demonstrated Improvement in OFF Time and Dyskinesia-Free ON Time^‡4,5

*Unified Parkinson's Disease Rating Scale (UPDRS). An overall improvement in score of at least 4.1 points is considered clinically meaningful.⁶ At study entry, patients with a fluctuation of <5 points were considered to have stable symptoms.
^†ZELAPAR dose: initial dose of 1.25 mg/day increased to 2.5 mg/day after 10 days.
^‡ON time and dyskinesia-free ON time were secondary end points of the trial.

IMPORTANT SAFETY INFORMATION

Indication

Zelapar is indicated as an adjunct therapy for Parkinson's disease patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this strategy. There is no evidence from controlled studies that Zelapar has any beneficial effect in the absence of concurrent levodopa therapy.

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 other selegiline products; at least 14 days should elapse between discontinuation of Zelapar and beginning these therapies. Zelapar should not be administered with the analgesic agents tramadol, methadone and propoxyphene, or with the antitussive agent dextromethorphan. In general, treatment with tricyclic antidepressants, SSRIs, and SNRIs should be avoided in combination with Zelapar.

Daily doses of Zelapar should not exceed 2.5 mg/day because of the risks associated with nonselective inhibition of MAO.

In clinical trials, the incidence of adverse orthostatic hypotension was higher in geriatric patients but not in non-geriatric 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 common adverse events in controlled trials were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, stomatitis and dyspepsia.

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Clarke A, Brewer F, Johnson ES, et al. A new formulation of selegiline: improved bioavailability and selectivity for MAO-B inhibition. J Neural Transm. 2003;110(11):1241-1255.
Clarke A, Johnson ES, Mallard N, et al. A new low-dose formulation of selegiline: clinical efficacy, patient preference and selectivity for MAO-B inhibition. J Neural Transm. 2003;110(11):1257-1271.
Ondo WG, Hunter C, Davidson A, et al. Tolerability and efficacy of switching from swallowed selegiline to Zydis selegiline (ZELAPAR^®) in patients with Parkinson's disease. Mov Disord. 2008;23 (suppl 1):S222.
Waters CH, Sethi KD, Hauser RA, Molho E, Bertoni JM; Zydis Selegiline Study Group. Zydis selegiline reduces off time in Parkinson's disease patients with motor fluctuations: a 3-month, randomized, placebo-controlled study. Mov Disord. 2004;19(4):426-432.
Tetrud JW, Koller WC. A novel formulation of selegiline for the treatment of Parkinson's disease. Neurology. 2004;63(7 suppl 2):S2-S6.
Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The clinically important difference on the Unified Parkinson's Disease Rating Scale. Arch Neurol. 2010;67:64-70.

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