carbidopa, levodopa and entacapone
Drug Details
- Generic Name
- carbidopa, levodopa and entacapone
- Brand Names
- carbidopa, levodopa and entacapone
- Application Number
- ANDA218535
- Sponsor
- Alembic Pharmaceuticals Inc.
- NDC Codes
- 12
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- CARBIDOPA, ENTACAPONE, LEVODOPA
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 )