Drugs
Entacapone/Carbidopa/Levodopa (marketed as Stalevo) Information
Stalevo contains the active ingredients (entacapone, carbidopa and levodopa) and is indicated to treat patients with idiopathic Parkinson's disease:
1. To substitute (with equivalent strength of each of the active ingredients) for immediate-release carbidopa/levodopa and entacapone previously administered as individual products.
2. To replace immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" (only for patients taking a total daily dose of levodopa of 600 mg or less and not experiencing dyskinesias).
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.
Related Information
FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk
8/20/2010FDA Drug Safety Podcast for Healthcare Professionals: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk
8/23/2010FDA Drug Safety Communication: Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer
3/31/2010Podcast for Healthcare Professionals:Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer
4/7/2010
Labeling and Regulatory History from Drugs@FDA
Contact FDA
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
