Indications
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 is 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 )
Contraindications
Carbidopa, levodopa and entacapone tablets are contraindicated in patients:
- Taking nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine). These nonselective MAO inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa, levodopa and entacapone tablets.
- With narrow-angle glaucoma.
- Concomitant use of nonselective monoamine oxidase (MAO) inhibitors ( 4 )
- Narrow-angle glaucoma ( 4 )
Warnings and precautions
The following adverse reactions described in this section are related to at least one of the components of carbidopa, levodopa and entacapone tablets (i.e., levodopa, carbidopa, and/or entacapone) based upon the safety experience in clinical trials (especially pivotal trials) or in postmarketing reports.
- May cause falling asleep during activities of daily living without apparent warning, and daytime drowsiness and somnolence ( 5.1 )
At a glance
- Brand name
- Stalevo 100
- Active substance
- carbidopa
- Pharmacologic class
- Aromatic Amino Acid, Aromatic Amino Acid Decarboxylation Inhibitor, Catechol-O-Methyltransferase Inhibitor
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Orion Pharma
- Status
- Prescription
- FDA approval
- 11 Jun 2003
- Application
- NDA021485-002