ABSTRACT
Background: Scientific literature advocates the need for combination therapies in combatting lower respiratory tract infection (LRTI). Cefixime (400 mg) and moxifloxacin (400 mg) fixed dose combination (FDC) is currently approved in India for the management of LRTI, but data related to its real world usage is lacking. The present study was designed to understand the real world use (effectiveness and safety) of this FDC in LRTI.Methods: This retrospective study was conducted at out-patient departments of 5 hospitals between August 2018 and January 2019. After ethics committee approval, data of adults LRTI patients who received FDC of cefixime (400 mg) and moxifloxacin (400 mg) for at least 72 hours was collected. Improvement in LRTI symptoms (cough, sputum volume and purulence, fever, dyspnea, pleuritic chest pain, sleep disturbance, fatigue) were scored at baseline and follow-up using a 5-point severity scale. White blood cell (WBC) counts at baseline and end-of-treatment were compared.Results: Data of 190 patients having mean age 42.33+16.15 years was evaluated. Majority were males (61.58%), with commonest LRTI infection being community acquired pneumonia (CAP) (84.21%). Commonest clinical symptom reported (97.37%) was cough. All patients showed improvement in symptoms and significant improvement in all mean symptom scores were noted (p<0.05). Of the 30 patients having WBC above normal range, 29 showed a decrease in count at end of treatment. No adverse events were reported.Conclusions: Oral FDC of cefixime (400 mg) and moxifloxacin (400 mg) was efficacious in improving all symptoms reported by LRTI patients without causing any adverse event.
ABSTRACT
Background: Cefixime is an oral extended spectrum third generation cephalosporin, which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms, effective in the treatment of community-acquired infections such as respiratory tract infection and urinary tract infection. The objective of this randomized, crossover study was to compare the bioequivalence (BE) of two tablets of test (Milixim® 200 mg, containing 200 mg of cefixime) with Reference formulation (Cefixime, 400 mg). Methods: A total of 12 healthy volunteers were randomly assigned to crossover, single-dose treatment regimens. Serial blood samples were collected, and plasma concentrations of cefixime were analyzed using the high-performance liquid chromatographic technique. Pharmacokinetic parameters and BE limits were calculated using non-compartmental methods. Results: The mean Cmax for the test and reference formulations were 4435.0298±149 and 4408.2150±1021 ng/mL, respectively. The mean area under the serum concentration curve (AUC)0-t were 38108.2614±8583.6535 and 38457.5791±8105.2529 ng/hr/mL The mean ratios (test: reference) for Cmax, AUC0-t, were 99.7% and 98.5%, respectively. There were no significant differences in pharmacokinetic parameters between groups. Overall, the 90% confi dence interval for the intra-individual ratios of the log-transformed Cmax and AUC values of the two formulations were within the BE interval of 80-125%. Conclusion: The study has demonstrated the BE of milixim and reference formulation of cefixime.