Starting STALEVO

How to transfer patients taking carbidopa-levodopa preparations and Comtan® (entacapone) tablets to STALEVO (carbidopa, levodopa, and entacapone) tablets:

There is no experience in transferring patients currently treated with formulations of carbidopa-levodopa other than immediate-release carbidopa-levodopa with a 1:4 ratio (controlled-release formulations, or standard release presentations with a 1:10 ratio of carbidopa-levodopa) and entacapone to STALEVO. Patients who are currently treated with one Comtan 200 mg tablet with each dose of standard release carbidopa-levodopa can be directly switched to the corresponding strength of STALEVO containing the same amounts of levodopa and carbidopa. For example, patients receiving one tablet of standard-release carbidopa-levodopa 25/100 mg and one tablet of Comtan 200 mg at each administration can be switched to a single STALEVO 100 tablet (containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone).

How to transfer patients not currently treated with Comtan® (entacapone) tablets from carbidopa-levodopa to STALEVO (carbidopa, levodopa, and entacapone) tablets:

In patients with Parkinson's disease who experience the signs and symptoms of end-of-dose "wearing-off" on their current standard-release carbidopa-levodopa treatment, clinical experience shows that patients with a history of moderate or severe dyskinesias or taking more than 600 mg of levodopa per day are likely to require a reduction in daily levodopa dose when entacapone is added to their treatment. Since dose adjustment of the individual components is impossible with fixed dose products, it is recommended that patients first be titrated individually with a carbidopa-levodopa product (ratio 1:4) and an entacapone product, and then transferred to a corresponding dose of STALEVO once the patient's status has stabilized. In patients who take a total daily levodopa dose up to 600 mg, and who do not have dyskinesias, an attempt can be made to transfer to the corresponding daily dose of STALEVO. Even in these patients, a reduction of carbidopa-levodopa or entacapone may be necessary however, and the provider is reminded that this may not be possible with STALEVO. Since entacapone prolongs and enhances the effects of levodopa, therapy should be individualized and adjusted if necessary according to the desired therapeutic response.

Please see Important Safety Information.