COMPARISON OF THE EFFECTS OF CIMETIDINE AND METHYLDOPA ON THE PHARMACOKINETICS OF PARACETAMOL IN HUMAN
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ABSTRACT
Comparison of the effects of cimetidine and methyldopa were studied in 5 phases: via phase I, ingestion of paracetamol 1g alone, phase II, administration of paracetamol 1g and cimetidine 400mg concurrently, phase III administration of cimetidine 400mg followed by paracetamol 1g after an hour, phase IV, ingestion of paracetamol 1g and methyldopa 250mg concomitantly, phase V, administration of methyldopa 250mg followed by paracetamol 1g an hour after. The protocol involves 8 healthy male volunteers, non-smokers and non-alcoholic who fast overnight. Saliva samples were usually collected after ingestion of the drugs for different phases at an interval of 0.25, 0.5, 1, 2, 3, 4, 5 hours for extraction and analysis. Analytical method was used to determine paracetamol concentration using ultraviolent spectroscopic meter. The method was validated for both; within day and between day processions with extract recovery of 96%. The pharmacokinetic parameters for the five phases were determined using a log transfer data, these are Cmax, Tmax, Kβ, Kα, t1/2α, t1/2α, t1/2 ,Cl, and Vd. and AUC curves were used to generate pharmacokinetic parameters. The data obtained were compared, with values of P > 0.05 considered to be statistically significant. When cimetidine and paracetamol were concomitantly administered no significant change was observed (P < 0.10) with values obtained when paracetamol was administered alone (control), on the other hand when paracetamol was administered an hour after cimetidine significant changes of pharmacokinetic parameters of paracetamol viii were recorded and compared to the value of the control phase. In this phase Paracetamol administration was analyzed by an hour after cimetidine ingestion. There are so many changes observed compared to the phase one parameters obtained this is as a result of possible drug interaction sequence to the inhibition of Paracetamol a absorption by cimetidine it could be seen that there is considerable reduction in the figures of Cmax and Kab by 36.45 % and 47.05% respectively (P< 0.05) which clearly indicates that there is a reduction in the absorption of Paracetamol. Tmax, t½αand lag time had significantly increased by 52.40% 52.5% and 43.78% respectively (P<0.050).It was also observed that there are insignificant changes in the pharmacokinetic parameters of paracetamol when paracetamol was administered with methyldopa irrespective of time interval leading to a suggestion that there is no influence in the pharmacokinetics of paracetamol by methyldopa. The findings indicate that on comparison, cimetidine may influence the pharmacokinetics of paracetamol depending on time of administration of the two drugs. While no change of pharmacokinetic parameters observed when methyldopa was administered with paracetamol irrespective of time interval.
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