carbidopa, levodopa and entacapone
carbidopa, levodopa and entacapone is listed in the FDA National Drug Code directory with 12 NDC codes, marketed under brand name including carbidopa, levodopa and entacapone. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- carbidopa, levodopa and entacapone
- Brand Names
- carbidopa, levodopa and entacapone
- Application Number
- ANDA218535
- Sponsor
- Alembic Pharmaceuticals Limited
- NDC Codes
- 12
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- CARBIDOPA, LEVODOPA, 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 )