SAFETY ASSESSMENT OF L-DOPA AND HYOSCINE HYDROBROMIDE IN COMBINATION: ACUTE AND SUB-ACUTE ORAL TOXICITY STUDIES
Keywords:Nil, Toxicity, L-dopa, Hyoscine hydrobromide
Objective: To evaluate the safety of L-Dopa and hyoscine hydrobromide combination by determining its potential toxicity after acute and sub-acute oral administration in rats.
Methods: The acute and sub-acute toxicity study was performed according to the Organisation for Economic Co-operation and DevelopmentÂ (OECD) Guideline 423 and 407 respectively. The combination of L-dopa and hyoscine hydrobromide was administered at 5 times the upper limit of therapeutic dose of each drug which is 1200 mg/d for L-dopa and 0.75 mg/d for hyoscine hydrobromide for adult human being and which was converted to required dose for Wistar rats (3 males and 3 females).
Results: The combination of L-dopa and hyoscine hydrobromide at 5 times the upper therapeutic dose produced no treatment-related signs of toxicity or mortality in any of the animals tested during 14 d of the study. In the repeated dose 28 d oral toxicity study, there was no significant difference in any of the assigned parameters between the control and all treatment groups.
Conclusion: It is established that the combination therapy of L-dopa and hyoscine hydrobromide is safe at 5 times the upper limit of therapeutics dose of each drug.
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