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ZELAPAR is indicated as an adjunct in the management of patients with Parkinson's 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 ZELAPAR has any beneficial effect in the absence of concurrent levodopa therapy [see Clinical Studies].
DOSAGE AND ADMINISTRATION
General Dosage Recommendations
Initiate treatment with 1.25 mg given once a day for at least 6 weeks. After 6 weeks, the dose may be increased to 2.5 mg given once a day if a desired benefit has not been achieved and the patient is tolerating ZELAPAR. There is no evidence that doses greater than 2.5 mg a day provide additional benefit, and they should ordinarily be avoided because of the potential increased risk of adverse events.
Take ZELAPAR in the morning before breakfast and without liquid. Patients should avoid ingesting food or liquids for 5 minutes before and after taking ZELAPAR.
Patients should not attempt to push ZELAPAR 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 ZELAPAR tablet(s) on top of the tongue where it will disintegrate in seconds.
Patients With Hepatic Impairment
In patients with mild to moderate hepatic disease (Child-Pugh score 5 to 9), the daily dose of ZELAPAR should be reduced (from 2.5 to 1.25 mg daily), depending on the clinical response. ZELAPAR is not recommended in patients with severe hepatic impairment (Child-Pugh score greater than 9) [see Use In Specific Populations and CLINICAL PHARMACOLOGY].
Patients With Renal Impairment
No dose adjustment of ZELAPAR is required in patients with mild to moderate renal impairment (creatinine clearance [CLcr] 30 to 89 mL/min). The maintenance dose of ZELAPAR (1.25 mg or 2.5 mg) is determined by the individual clinical response. ZELAPAR is not recommended in patients with severe renal impairment and patients with end-stage renal disease [ESRD] (creatinine clearance [CLcr] < 30 mL/min) [see Use In Specific Populations and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
ZELAPAR Orally Disintegrating Tablets contain 1.25 mg selegiline hydrochloride.
Storage And Handling
ZELAPAR 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 carton. Neither the blister card nor the pouch is child-resistant.
ZELAPAR (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.
Distributed by: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA. Manufactured by: Catalent Health, Inc. Swindon, Wiltshire, SN5 8RU, UK. Rev. 07/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/29/2014
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