Description
Tridopa® is a combination of levodopa, carbidopa and entacapone for the treatment of
Parkinson’s disease. Levodopa is the metabolic precursor of dopamine, it crosses the bloodbrain
barrier and is converted to dopamine in the brain. Carbidopa is a dopa decarboxylase
(DDC) inhibitor which reduces the peripheral metabolism of levodopa to dopamine,
Dose and administration
Adults:
The optimum daily dose must be determined by careful titration of levodopa in each patient.
Patients should be instructed to take only 1 (one) Tridopa® tablet per dose administration.
The maximum recommended daily dose of entacapone is 2,000 mg and therefore the
maximum dose is 10 (ten) tablets/day for Tridopa® 50, Tridopa® 100, Tridopa® 150; and 7
(seven) tablets/day of Tridopa® 200.
Usually Tridopa® is to be used in patients who are currently treated with corresponding
doses of standard release levodopa/DDC inhibitor and entacapone.
Method of administration
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.
How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide)
preparations and entacapone tablets to Tridopa®
a. Patients who are currently treated with entacapone and with standard release
levodopa/carbidopa in doses equal to Tridopa® tablet strengths can be directly transferred
to corresponding Tridopa® tablets.
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 Tridopa® should be considered, within the dose recommendations.
When less levodopa is required, the total daily dose of Tridopa® should be reduced either by
decreasing the frequency of administration by extending the time between doses, or by
decreasing the strength of Tridopa® at an administration.
If other levodopa products are used concomitantly with a Tridopa® tablet, the maximum
dose recommendations should be followed.
Discontinuation of Tridopa® therapy:
If Tridopa® treatment (levodopa/carbidopa/entacapone) is discontinued and the patient is
transferred to levodopa/DDC inhibitor therapy without entacapone, it is necessary to adjust
the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient
level of control of the parkinsonian symptoms.
Children:
Safety and effectiveness in pediatric patients have not been established.
Elderly:
No dose adjustment is required for elderly patients.
Hepatic impaired patients:
Should be administered cautiously to patients with mild to moderate hepatic impairment.
Dose reduction may be needed.
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