BRISTOL-MYERS SQUIBB MAXIPIME TO BE INTRODUCED IN SECOND QUARTER, the company indicated Jan. 24. The intravenous cephalosporin antibiotic cefepime (NDA 50-679) was approved Jan. 18 for uncomplicated and complicated urinary tract infections, uncomplicated skin and skin structure infections and pneumonia ("The Pink Sheet" Jan. 22, T&G-1).

Maxipime gives Bristol a branded intravenous cephalosporin to complement its presence in the oral cephalosporin market. BMS' Cefzil (cefprozil) became the number one prescribed oral cephalosporin in the U.S. in October ("The Pink Sheet Dec. 18, 1995, p. 21).

The recommended cefepime dose for mild to moderate UTIs is .5 g to 1 g intravenously or intramuscularly b.i.d. for seven to 10 days; for severe UTIs, 2 g I.V. twice daily for 10 days; for pneumonia, 1 g to 2 g I.V. twice daily for 10 days; and for skin and skin structure infections, 2 g I.V. twice daily for 10 days. The intravenous administration should occur over approximately 30 minutes, labeling states.

"Dosage administration of cefepime in the elderly should be adjusted as appropriate if the patient's creatinine clearance is 60 mL/minute or less" because "there appeared to be a decrease in cefepime total body clearance as a function of creatinine clearance," according to labeling.

"Cefepime total body clearance decreased proportionally with creatinine clearance in patients with abnormal renal function which serves as the basis for dosage adjustment recommendations in this group of patients," labeling states. No dose adjustment is necessary for patients with impaired hepatic function, labeling notes.

Cefepime, like many cephalosporins, has been associated with a fall in prothrombin activity, labeling cautions. Patients at risk include those with renal or hepatic impairment, poor nutritional state or who have received a protracted course of antimicrobial therapy.

Several adverse events other than those that appeared in clinical trials have been reported in postmarketing use with Maxipime abroad, according to labeling. Encephalopathy appeared in renally-impaired patients treated with unadjusted doses of cefepime. Cephalosporins also have been implicated in seizures, especially in patients with renal impairment for whom the dose was not adjusted.

Maxipime was found to have in vitro clinical activity against Gram-positive microorganisms such as Staphylococcus epidemidis, S. saprophyticus and Streptococcus agalactiae and against numerous Gram-negative microorganisms such as Acinetobacter cacloaceticus, Citrobacter diversus, Hafnia alvei, Morganella morganii, Providencia rettgeri, Serratia marcescens and others. However, the clinical efficacy of Maxipime against these microorganisms has not been established.

Bristol's Maxipime antibiotic will launch in second quarter; recommended dose ranges from .5 g to 2 g b.i.d.

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