Retrospective survey on efficacy of cefixime-ofloxacin 400 milligram sustained release fixed-dose combination tablet for enteric fever in community settings of India

Background: The World Health Organization (WHO) estimate for annual global incidence of typhoid fever, about 21 million cases, is probably an underestimate because of poor diagnostics. Multi-drug resistant (MDR) isolates and nalidixic resistant isolates have limited the choice of oral drugs available for the treatment of typhoid fever. Recently the Indian regulatory authority approved an oral fixed dose combination (FDC) of cefixime and ofloxacin for the treatment of typhoid fever.Methods: Retrospective survey was planned to observe the efficacy of cefixime-ofloxacin 400 mg sustained release (SR) FDC tablet for enteric fever in community settings of India. Family physicians involved in the management of enteric fever cases were selected across 4 zones (East, South, West, and North) each by convenient sampling to have uniform representation of population across the country. Each physician was given survey questionnaire booklet containing survey forms.Results: Total 78 family physicians participated in the survey with 881 completed questionnaire forms. Hypertension, diabetes were present in 83% (N=244) patients with comorbid conditions. One hundred and fifty four (17.4%) cases revealed history of relapse or recurrence. Fever clearance rate of 97% was observed in overall evaluable population. Sub analysis in high risk cases (relapse/recurrence) showed equally good response to the combination as cases without defervescence on day 3 and day 7 were only 21.4% and 1.3% respectively.Conclusions: Based on the present study we believe that cefixime-ofloxacin 400mg SR FDC to be an appropriate choice in the management of resistant enteric fever cases, especially in presence of comorbid conditions like hypertension or diabetes which adds to excess pill burden

Open-label, randomized, crossover comparative bioavailability study of cefixime from two tablet formulations after single oral administration

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% confidence 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

ICS/Ultra LABA in the Treatment of Obstructive Airway Diseases: A Consensus of Indian Experts

Inhaled corticosteroid and ultra-long-acting beta-agonist (ICS/uLABA) combination is a recent advancement in the armamentarium against obstructive airways diseases (OADs). The combination of ICS/uLABA has several advantages, creating a favorable landscape for its utilization. Fluticasone furoate/vilanterol trifenatate (FF/Vi) is one such example of an ICS/uLABA. It offers several benefits from both drugs, such as a convenient once daily dosing schedule; high lipophilicity; high receptor affinity of fluticasone furoate along with high functional selectivity and a quick onset of action of vilanterol. However, the Global Initiative for Asthma (GINA) as well as the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines do not clearly define the positioning of ICS/uLABA compared to conventional ICS/LABAs. There are a few areas of uncertainty especially around the appropriate reliever strategy with ICS/uLABA in Asthma. The current consensus was planned with a group of Indian pulmonology experts to provide more clarity on the potential use of FF/Vi in Asthma and COPD. The clinical statements highlighted in this consensus manuscript address crucial clinical questions revolving around the efficacy and safety of FF/Vi as compared to conventional ICS/LABAs and identify the ideal patient profile for its use. This consensus paper also sheds light upon the appropriate reliever to be used along with FF/Vi in Asthma and the utilization of FF/Vi-based triple therapy in OADs. Expert recommendations mentioned in this paper will serve as guidance to pulmonologists as well as consultant physicians who are involved in providing care to OAD patients and will help them weigh the various factors that need to be taken into account while prescribing ICS/uLABA combination

ExPert ConsEnsus on the management of Advanced clear-cell RenaL celL carcinoma: INDIAn Perspective (PEARL-INDIA)

Abstract In advanced Renal Cell Carcinoma (aRCC), systemic therapy is the mainstay of treatment, with no or little role for surgery in these patients. Tyrosine kinase inhibitors (TKIs) and immune-oncological (IOs) therapies, either alone or in combination, are recommended in these patients depending on patient and tumour factors. The sequencing of therapies is critical in RCC because the choice of subsequent line therapy is heavily dependent on the response and duration of the previous treatment. There are additional barriers to RCC treatment in India. Immunotherapy is the cornerstone of treatment in ccRCC, but it is prohibitively expensive and not always reimbursed, effectively putting it out of reach for the vast majority of eligible patients in India. Furthermore, in advanced RCC (particularly the clear cell variety), Indian oncologists consider the disease burden of the patients, which is particularly dependent on the quantum of the disease load, clinical symptoms, and performance status of the patient, before deciding on treatment. There are no India-specific guidelines for clear cell RCC (ccRCC) treatment or the positioning and sequencing of molecules in the management of advanced ccRCC that take these country-specific issues into account. The current consensus article provides expert recommendations and treatment algorithms based on existing clinical evidence, which will be useful to specialists managing advanced ccRCC