ZELAPARÃ? is indicated as an adjunct in the management of patients with Parkinsons disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that ZELAPARÃ? has any beneficial effect in the absence of concurrent levodopa therapy.

ZELAPARÃ? is intended for administration to patients with Parkinsons disease receiving levodopa/carbidopa therapy who demonstrate a deteriorating response to this treatment.

Treatment should be initiated with 1.25 mg given once a day for at least 6 weeks. After 6 weeks, the dose may be escalated to 2.5 mg given once a day if a desired benefit has not been achieved and the patient is tolerating ZELAPARÃ?. There is no evidence that doses greater than 2.5 mg a day confer any additional benefit, and they should ordinarily be avoided because of the potential increased risk of adverse events.

ZELAPARÃ? should be taken in the morning before breakfast and without liquid.

In the controlled trial of ZELAPARÃ? in which ZELAPARÃ? was shown to be effective compared to placebo, 17% of patients in the ZELAPARÃ? group and 19% of patients in the placebo treatment group had a reduction in their doses of levodopa/carbidopa because of perceived dopaminergic side effects. For those patients with a dose reduction, the average reduction was 24% for ZELAPARÃ? and 21% for placebo.

Patients should not attempt to push ZELAPARÃ? through the foil backing. Patients should PEEL BACK the backing of one or two blisters (as prescribed) with dry hands, and GENTLY remove the tablet(s). Patients should IMMEDIATELY place the ZELAPARÃ? tablet(s) on top of the tongue where it will disintegrate in seconds. Patients should avoid ingesting food or liquids for 5 minutes before and after taking ZELAPARÃ?.

ZELAPARÃ? Orally Disintegrating Tablets are available containing 1.25 mg selegiline hydrochloride in a zydis formulation. Each pale yellow tablet is imprinted with a stylized "V". Ten tablets are contained in a moisture-resistant pouch and packaged in a child-resistant carton. Neither the blister card nor the pouch is child-resistant.

ZELAPARÃ? (selegiline hydrochloride) is available as: NDC 0187-0453-02, carton of 6 pouches (60 tablets).

Store at controlled room temperature, 25°C (-77°F); excursions permitted to 15-30°C (59-86°F). Use within 3 months of opening pouch and immediately upon opening individual blister. Store blister tablets in pouch. Potency cannot be guaranteed after 3 months of opening the pouch.

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