Efficacy and Safety of Fixed Dose Combination of Cefpodoxime Proxetil and Potassium Clavulanate (Cefchamp) in Comparison with Cefuroxime Axetil in Patients with Lower Respiratory Tract Infections.

Objectives: To evaluate the efficacy and safety of Fixed Dose Combination of Cefpodoxime Proxetil and Potassium Clavulanate (Cefchamp) in comparison with Cefuroxime Axetil in patients with Lower Respiratory Tract Infections.Methods:In this open, randomized, and controlled, parallel-group study of 7 days, 57 patients of both gender above 18 years of age with diagnosis of lower respiratory tract infection were randomized to receive Fixed Dose Combination (FDC) of Cefpodoxime Proxetil plus Potassium Clavulanate (Cefchamp), or Cefuroxime Axetil (CA) for a period of 7 days. Efficacy was assessed by symptoms of cough, dyspnoea, wheezing, Rhonchi, and chest pain based on 4-point scale as 0=none,1=mild, 2=moderate, 3=severe. Fever was recorded as the patient’s actual temperature. Safety assessment included adverse events and adverse drug reactions during the study period.Results: Three patients lost to follow up with CA.The improvement in all symptoms except cough was greater with CC as compared to CA group(p, >0.05). Fever improved from 37.18°C at baseline to 37.01 on day 3 with CC, whereas with CA the fever improved from 37.l5 at baseline to 37.05 on day 3 with CA. Fever subsided in all the patients in both treatments by day 5 of study therapy. Clinical cure was seen in 57.14% (16/28) patients on CC, whereas 42.3% patients (11/26) on CA had clinical cure.Conclusions:The fixed dose combination of Cefpodoxime Proxetil 200 mg and Potassium Clavulanate 125mg (Cefchamp) in comparison with Cefuroxime Axetil 500 mg showed improvement in the cure of respiratory tract infections in terms of decreasing the patient’s LRTI symptoms, improving the patient’s general health and with few adverse events and adverse drug reactions. However, further studies of greater sample size and blinded nature are needed to further substantiate this effect.

Effect of two types of Indian breakfast on bioavailability of cefuroxime axetil.

BACKGROUND & OBJECTIVES: The oral bioavailability of cefuroxime axetil is enhanced by food. This study was done to compare the effect of two types of Indian breakfast on the bioavailability of cefuroxime axetil in healthy volunteers. METHODS: Eight healthy male volunteers participated in the crossover study. Subjects were randomized to receive either one of the two types of breakfast, Diet-A or Diet-B, 10 min before single dose of 500 mg cefuroxime axetil. After a washout period of one week the study was repeated with the other type of diet. Diet-A included idly with chutney. Diet-B included poori and dal-fry. Blood samples for pharmacokinetic analysis were obtained prior to dosing and at 0.25, 0.50, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 8.0 h following dosing and urine collections were done for 8 h. The serum and urine samples were assayed by using HPLC. RESULTS: The AUC and Cmax were significantly increased after oral administration of cefuroxime axetil with Diet-B, when compared to Diet-A (P < 0.01 and P < 0.02 respectively). The values of apparent absorption rate constant, lag-time, Tmax and t1/2 beta for the two regimens were not significantly different. The volume of distribution and plasma clearance for cefuroxime were significantly lower (P < 0.02, P < 0.001 respectively) in the regimen with Diet-B. The 8 h urinary recovery of cefuroxime was 16.59 and 28.44 per cent (P < 0.005) with Diet-A and Diet-B respectively. INTERPRETATION & CONCLUSIONS: The administration of cefuroxime axetil with poori and dal-fry may enhance the bioavailability when compared with idly and chutney.

Cefuroxime axetil in the treatment of Salmonella typhi infection (enteric fever) in adults.

A study to evaluate the efficacy and safety of Cefuroxime Axetil in enteric fever was carried out in 30 adult hospitalised patients of either sex. A positive blood culture for S. typhi and sensitivity to cefuroxime axetil were confirmed prior to treatment. On admission, the baseline signs and symptoms were recorded and treatment initiated with cefuroxime axetil in a dose of 500 mg bd; which was continued for 7 days after normalization of temperature. The various clinical parameters were followed up daily during the treatment period and discharge permitted on normalization of temperature. Blood culture for S. typhi was repeated 3 days after stopping treatment. Follow-up Widal, stool and urine cultures were done wherever possible to check for relapse or carrier state. All the patients responded clinically to treatment and had bacteriologically negative blood cultures by the end of 14 days treatment. 87% of the patients responded within 7 days of treatment of which 60% were graded as Excellent responders as they responded within 4 days itself; while 13% took a longer time to respond. There were no relapses or carrier state as indicated by negative follow-up stool cultures. Only one patient reported a side-effect of mild headache confirming the safety of the drug. We conclude that Cefuroxime axetil in a dose of 500 mg bd is an effective and safe drug in the treatment of multi drug resistant enteric fever.