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 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