entacapone

FDA Drug Profile — Entacapone

entacapone is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Entacapone. Available dosage forms: tablet, film coated, powder.

Drug Details

Generic Name
entacapone
Brand Names
Entacapone
Application Number
ANDA206669
Sponsor
Orion Corporation, Orion Pharma
NDC Codes
4
Dosage Forms
TABLET, FILM COATED, POWDER
Routes
ORAL
Active Ingredients
ENTACAPONE

Indications and Usage

1 INDICATIONS AND USAGE Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: • To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. • To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa (aromatic amino acid), carbidopa (aromatic amino acid decarboxylation inhibitor), and entacapone (catechol-O-methyltransferase (COMT) inhibitor) is indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets are to be used: • To substitute (with equivalent strengths of each of the three components) for carbidopa/levodopa and entacapone previously administered as individual products ( 1 ) • To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias ( 1 )