A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Eldepryl Indications, Dosage, Storage, Stability - Selegiline
Eldepryl Indications, Dosage, Storage, Stability - Selegiline
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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