SELEGILINE HYDROCHLORIDE- selegiline hydrochloride tablet
Mylan Pharmaceuticals Inc.
DESCRIPTION
Selegiline hydrochloride is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.
The chemical name is: (R)-(-)-N,2-dimethylpropynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75
Each tablet, for oral administration, contains 5 mg selegiline hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: citric acid, lactose monohydrate, maize starch, magnesium stearate, povidone and talc.
CLINICAL PHARMACOLOGY
The mechanisms accounting for selegiline�s beneficial adjunctive action in the treatment of Parkinson�s disease are not fully understood. Inhibition of monoamine oxidase, type B, activity is generally considered to be of primary importance; in addition, there is evidence that selegiline may act through other mechanisms to increase dopaminergic activity.
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.
