Selegiline Hydrochloride selegiline hydrochloride 5 MG Oral Tablet
INDICATIONS AND USAGE Selegiline hydrochloride tablets are indicated as an adjunct in the management of Parkinsonian patients 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 selegiline hydrochloride tablets have any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline hydrochloride tablets or placebo in patients receiving levodopa/carbidopa. Selegiline hydrochloride tablets were significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state).
Mylan Pharmaceuticals Inc.
ROUND WHITE G SE 5
G SE 5 ROUND WHITE
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HOW SUPPLIED Selegiline Hydrochloride Tablets, USP are available containing 5 mg of selegiline hydrochloride, USP. Each white, round, unscored tablet is debossed with G on one side and SE over 5 on the other side. They are available as follows: NDC 0378-9290-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The brand names mentioned are registered trademarks of their respective manufacturers. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Revised: 3/2017 ALP:SELG:R2
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