Int J Clin Pharm Th
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Int J Clin Pharm Th · Dec 1998
Integrated pharmacokinetics and pharmacodynamics of the novel calcium sensitizer levosimendan as assessed by systolic time intervals.
Levosimendan is a new calcium sensitizer, acting calcium-dependently on cardiac troponin C. In the present study pharmacokinetic-pharmacodynamic interrelations of levosimendan were assessed. ⋯ In conclusion, the pharmacokinetic-dynamic behavior of the inotropy index QS2i indicates an equilibration delay of levosimendan, which most probably reflects the time the drug requires to distribute from plasma to its cardiac site of action. The deviant kinetic-dynamic profile of the oral slow-release formulation suggests a different absorption pattern of levosimendan from this formulation.
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Int J Clin Pharm Th · Oct 1998
Randomized Controlled Trial Clinical TrialProspective randomized study of once-daily versus twice-daily amikacin regimens in patients with systemic infections.
The efficacy and safety of amikacin administered once-daily versus twice-daily was evaluated in adult patients with systemic infections. Patients over 23 years of age with suspected or documented systemic infections were randomly divided into two groups: one group received amikacin intravenously 15 mg/kg once-daily, and the other group received amikacin 15 mg/kg divided into 2 doses. The efficacy of both dosage regimens was very good with a satisfactory clinical response in 90.2% and 89%, respectively. ⋯ No significant differences between the regimens with regard to hearing loss or prodromal signs of ototoxicity. We concluded that amikacin administered once-daily appears to be as effective and safe as the twice-daily dosing. However, the once-daily administration is more convenient and less costly.
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Int J Clin Pharm Th · Oct 1998
Randomized Controlled Trial Clinical TrialInteraction of omeprazole with enteric-coated salicylate tablets.
Enteric-coated tablets are designed to resist gastric fluids and to disrupt and dissolve in the alkaline medium of the small intestine. Main objective of the present study was to investigate whether the increase in gastric pH due to omeprazole treatment alters the release rate of a drug from enteric-coated formulation. To this end, we have compared the single dose pharmacokinetics of a single-unit enteric-coated salicylate to that of uncoated acetylsalicylic acid tablets in the presence and absence of omeprazole treatment. ⋯ Findings of the present study demonstrate that omeprazole treatment significantly increases the rate of absorption of single-unit enteric-coated medication. Enhanced rate of absorption is most probably due to an early disruption of enteric coating and the intragastric release of the drug secondary to an omeprazole-mediated increase in gastric pH. The results of the present study also corroborate previous findings which have demonstrated highly variable absorption of enteric-coated single units.
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Int J Clin Pharm Th · Jun 1998
Randomized Controlled Trial Comparative Study Clinical TrialComparison of psychomotor functions and sedation following premedication with oral diazepam and clonidine in children.
In a prospective, double-blind, controlled, randomized study, the psychomotor functions and sedation were assessed after premedication with diazepam and clonidine in children. Forty children in the age-group of 5-8 years, undergoing elective surgery under general anesthesia were studied. Twenty children (group 1) received oral clonidine 4 microg/kg, and 20 children (group 2) received oral diazepam 0.2 mg/kg, 120 minutes before induction of anesthesia. ⋯ The performance of psychomotor functions decreased after premedication in both the groups as compared to that before premedication (p < 0.05). The psychomotor functions were depressed more in diazepam group than in the clonidine group (p < 0.05). Thus, it is concluded that clonidine produces good sedation and causes less effect on psychomotor functions and therefore can be used for premedication in children.
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Int J Clin Pharm Th · Apr 1998
Randomized Controlled Trial Comparative Study Clinical TrialComparative bioavailability of two tablet formulations of acyclovir in healthy volunteers.
This investigation was carried out to evaluate the bioavailability of a new tablet formulation of acyclovir (400 mg), Clovir, relative to reference product, Zovirax (400 mg) tablets. The 2 brands were found to be similar in weight variation, disintegration time, dissolution, and assay as stipulated by the USPXXIII, as well as by the manufacturer. The bioavailability was carried out on 24 healthy male volunteers who received a single dose (400 mg) of the test (T) and the reference (R) products in the fasting state, in a randomized balanced 2-way crossover design. ⋯ The parametric confidence intervals (90%) of the mean values of the pharmacokinetic characteristics (AUC0-t, AUC0-infinity, Cmax, Cmax/AUC0-infinity) for T/R ratio were in each case, well within the bioequivalence acceptable range of 80-125%. The test formulation was found bioequivalent to the reference formulation by the Schuirmann's two 1-sided t tests and by Wilcoxon Mann Whitney two 1-sided tests procedure. Therefore, the 2 formulations were considered to be bioequivalent.