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K. Keyhani, L.E. Leguire, P.D. Walson, G.L. Rogers; Tolerance of L-dopa (Levodopa/Carbidopa) Used to Augment Occlusion Treatment for Children With Amblyopia . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4793.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: L-dopa has been used to augment occlusion treatment for children with amblyopia. Unfortunately, little is known of the tolerance of L-dopa in the pediatric population. To assess tolerance, the present study evaluated combined laboratory data from three previous studies of the use of L-dopa in children with amblyopia. Methods: Combined analysis of serum chemistry, hematologic tests, renal function tests, liver function tests and liver enzyme tests was undertaken in 32 children treated with L-dopa and occlusion treatment for amblyopia. Blood samples were taken at baseline, before drug dosing, and after seven weeks of L-dopa dosing at three different dosing levels. All subjects had amblyopia and were in otherwise good health at the time of enrollment. In all three studies, subjects received L-dopa (levodopa with a fixed dose combination of 25% carbidopa, known as Sinemet), for a 7-week period, three times daily. Data were compared within subjects and to age-based normative values. Results: For 35 blood tests, individual deviations from the normal range were similar at baseline and following 7-weeks of L-dopa dosing. Although several of the individual tests exhibited statistically significant changes in either the mean or in the variance from baseline to the 7-week test session, the percent change in each individual test was so small as to have no clinical significance. The means for each individual laboratory test remained well within the normal range. Conclusion: By combining the laboratory tests from three independent studies involving 32 children, the current data revealed that L-dopa has no clinically relevant effects on a host of laboratory tests. These data document the tolerability of L-dopa in children and reveal that L-dopa is well tolerated in the doses and time frames described.
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