Clinical evaluation and monitoring of adverse effects for fixed multidose combination against single drug therapy in pulmonary tuberculosis patients

To evaluate the clinical and therapeutic value of 4 and 3 drug fixed dose combinations verses single drug formulations to treat pulmonary tuberculosis patients. The occurrence of adverse effects was also monitored. A total of 293 patients having sputum positive pulmonary tuberculosis were enrolled [Male: 187 and Female: 106]. Patients with renal, hepatic, diabetic, cardiac problem and pregnancy were excluded from study. Patients were randomly selected into three groups [A, B, C]. Group A and B were given FDCs and group C was given single drug formulations. All patients received 4 drugs in the intensive phase and 3 drugs in the continuation phase. Group A showed the highest percentage of patients who achieved sputum conversion [98.9%]. The numbers of days taken to achieve sputum conversion on average were the least for Group B [32 days]. When comparing the adverse effects, the patients of Group C suffered the most, with 22 patients who vomited repeatedly, 3 complaining of itching, 2 with Jaundice and 1 dead. There was no significant difference in the efficacy among the three treatment regimens. However the side effects observed in all three groups strongly indicate that FDCs are safer for treating TB patients. There were no side effects in the continuation phase

Pharmacokinetics of ciprofloxacin in normal rabbits and changes observed in induced dehydrated state

The pharmacokinetics of ciprofloxacin following oral administration of a single dose of 20mg/Kg body weight was investigated in normal rabbits and changes were observed in water-deprived rabbits. High performance liquid chromatographic method was employed for the determination of plasma concentration of ciprofloxacin. The mean plasma concentration and AUC [0-t] and AUC [0-inf] were significantly different between normal and dehydrated rabbits [P < 0.05], but the absorption rate, distribution rate, and elimination rate did not show any statistically significant difference. The results reflect a need for monitoring toxicity of ciprofloxacin in the water-deprived condition

Disposition kinetics of ciprofloxacin after different oral dosage level in rabbits

Ciprofloxacin a flouroquinolone antibacterial drug was orally administered to healthy white albino rabbits [n=12] a single dose of 10, 20, and 30 mg/Kg body weight using a randomized crossover design. Plasma samples were collected at various times over 12 hours following drug administration. The drugs were detected by high performance liquid chromatography [HPLC], and plasma drug concentration versus time curve were subjected to non-compartment and two compartment pharmacokinetic analysis. Descriptive statistics were determined for each doses, and comparison were made among doses groups for selected pharmacokinetic parameters. Result indicated that increasing dose of ciprofloxacin resulted in increased plasma concentration. Maximum concentration [C max] was 0.43 + 0.007, 0.84 +/- 0.01, and 1.46+ 0.013 micro gm/ml for the doses of 10, 20, and 30mg/kg body weight. AUC[0-t], AUC[0-00] and MRT were significantly greater at 30mg/kg and showed significant difference with doses [P<0.05], where as other parameters like absorption rate constant, distribution rate constant and elimination rate constant did not show significant difference