INDICATIONS
Selegiline hydrochloride is 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 clinical 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.
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).
DOSAGE AND ADMINISTRATION
Selegiline hydrochloride is intended for administration
to Parkinsonian patients receiving levodopa/carbidopa
therapy who demonstrate a deteriorating response to this
treatment. The recommended regimen for the administration
of selegiline hydrochloride is 10 mg per day administered
as divided doses of 5 mg each taken at breakfast and lunch.
There is no evidence that additional benefit will be obtained
from the administration of higher doses. Moreover, higher
doses should ordinarily be avoided because of the increased
risk of side effects.
After two to three days of selegiline treatment, an attempt
may be made to reduce the dose of levodopa/carbidopa.
A reduction of 10 to 30% was achieved with the typical
participant in the domestic placebo controlled trials
who was assigned to selegiline treatment. Further reductions
of levodopa/carbidopa may be possible during continued
selegiline therapy.
HOW SUPPLIED
Eldepryl tablets are available containing 5 mg of selegiline
hydrochloride. Each white, shield shaped, unscored tablet
is debossed with "S" on one side and "5"
on the other side.
Carbex 5 mg tablets are white, oval tablets; debossed
with E620 on one side and plain on the other.
Store at controlled room temperature, 59° to 86°F
(15° to 30°C).
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