SELEGILINE HYDROCHLORIDE (Page 4 of 4)

DOSAGE AND ADMINISTRATION:

Selegiline hydrochloride capsules are 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 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

Product: 68151-2649

NDC: 68151-2649-0 1 CAPSULE in a PACKAGE

Selegiline HCL 5 mg capsules

Label ImageLabel Image
SELEGILINE HYDROCHLORIDE
selegiline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-2649(NDC:67253-700)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SELEGILINE HYDROCHLORIDE (SELEGILINE) SELEGILINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
LACTOSE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code S;700
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-2649-0 1 CAPSULE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075352 11/04/2006
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-2649)

Revised: 08/2016 Carilion Materials Management

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