Selegiline

Selegiline is indicated for the treatment of Parkinson's disease or symptomatic parkinsonism which is being treated with levodopa alone or levodopa and peripheral decarboxylase inhibitor. Selegiline, in conjunction with maximal levodopa treatment, is indicated particularly in patients during maximal levodopa treatment who develop fluctuations in their condition such as ‘end-dose’ type fluctuations, ‘on-off’ symptoms or other dyskinesias.

INDICATIONS AND USAGE

Selegiline Hydrochloride Tablets USP 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 has 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 or placebo in patients receiving levodopa/carbidopa. Selegiline was 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.

, 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).

SELEGILINE (selegiline hydrochloride) is contraindicated in patients with known hypersensitivity to this drug. SELEGILINE should not be used in patients with other extrapyramidal disorders such as excessive tremor or tardive dyskinesia, or in patients with severe psychosis or profound dementia.

SELEGILINE is contraindicated in combination with meperidine (see DRUG INTERACTIONS). This contraindication is often extended to other opioids as well. SELEGILINE should not be used in patients with active peptic ulcer. WARNINGS SELEGILINE (selegiline hydrochloride) should not be used at daily doses exceeding those recommended (10 mg/day) because of the risks associated with non-selective inhibition of MAO (see ACTIONS AND CLINICAL PHARMACOLOGY).

The selectivity of selegiline hydrochloride for MAO-B may not be absolute at the recommended daily dose of 10 mg/day, and selectivity is further diminished with increasing daily doses. The precise dose at which selegiline hydrochloride becomes a non-selective inhibitor of all MAO is unknown, but may be in the range of 30 to 40 mg per day.