Drug Class Description
Anti-parkinsonian dopaminergic
Generic Name
Levodopa/Carbidopa/Entacapone
Drug Description
Each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.Excipient: Each tablet contains 1.9 mg of sucrose
Presentation
Film-coated tabletBrownish or greyish red, elongated-ellipse shaped, unscored film-coated tablets marked with 'LCE 150' on one side.
Indications
Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Adult Dosage
Each tablet is to be taken orally either with or without food. One tablet contains one treatment dose and the tablet may only be administered as whole tablets.
The optimum daily dose must be determined by careful titration of levodopa in each patient. The daily dose should be preferably optimised using one of the six available tablet strengths (50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 150 mg/37.5 mg/200 mg or 200 mg/50 mg/200 mg levodopa/carbidopa/entacapone).
Patients should be instructed to take only one Stalevo tablet per dose administration. Patients receiving less than 70-100 mg carbidopa a day are more likely to experience nausea and vomiting. While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Stalevo strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg. Ten tablets of Stalevo 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day. According to this daily carbidopa dose, the maximum recommended daily Stalevo 200 mg/50 mg/200 mg dose is 7 tablets per day.
Usually Stalevo is to be used in patients who are currently treated with corresponding doses of standard release levodopa/DDC inhibitor and entacapone.
How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide) preparations and entacapone tablets to Stalevo
a. Patients who are currently treated with entacapone and with standard release levodopa/carbidopa in doses equal to Stalevo tablet strengths can be directly transferred to corresponding Stalevo tablets.
For example, a patient taking one tablet of 150 mg/37.5 mg of levodopa/carbidopa with one tablet of entacapone 200 mg four times daily can take one 150 mg/37.5 mg/200 mg Stalevo tablet four times daily in place of their usual levodopa/carbidopa and entacapone doses.
b. When initiating Stalevo therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Stalevo 150 mg/37.5 mg/200 mg, (or 50 mg/12.5 mg/200 mg, or 75 mg/18.75 mg/200 mg or 100 mg/25 mg/200 mg or 125 mg/31.25 mg/200 mg or 200 mg/50 mg/200 mg) tablets, Stalevo dosing should be carefully titrated for optimal clinical response. At the initiation, Stalevo should be adjusted to correspond as closely as possible to the total daily dose of levodopa currently used.
c. When initiating Stalevo in patients currently treated with entacapone and levodopa/benserazide in a standard release formulation, discontinue dosing of levodopa/benserazide the previous night, and start Stalevo the next morning. Begin with a dose of Stalevo that will provide either the same amount of levodopa or slightly (5-10%) more.
How to transfer patients not currently treated with entacapone to Stalevo
Initiation of Stalevo may be considered at corresponding doses to current treatment in some patients with Parkinson's disease and end-of-dose motor fluctuations, who are not stabilised on their current standard release levodopa/DDC inhibitor treatment. However, a direct switch from levodopa/DDC inhibitor to Stalevo is not recommended for patients who have dyskinesias or whose daily levodopa dose is above 800 mg. In such patients it is advisable to introduce entacapone treatment as a separate treatment (entacapone tablets) and adjust the levodopa dose if necessary, before switching to Stalevo.
Entacapone enhances the effects of levodopa. It may therefore be necessary, particularly in patients with dyskinesia, to reduce levodopa dose by 10-30% within the first days to first weeks after initiating Stalevo treatment. The daily dose of levodopa can be reduced by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Dose adjustment during the course of the treatment
When more levodopa is required, an increase in the frequency of doses and/or the use of an alternative strength of Stalevo should be considered, within the dose recommendations.
When less levodopa is required, the total daily dose of Stalevo should be reduced either by decreasing the frequency of administration by extending the time between doses, or by decreasing the strength of Stalevo at an administration.
If other levodopa products are used concomitantly with a Stalevo tablet, the maximum dose recommendations should be followed.
Discontinuation of Stalevo therapy
