SEFPIM Cefepime Hydrochloride for Injection Sterile powder for injection IM/IV [Indications] It is indicated in the treatment of infections caused by susceptible bacteria, for adults and children aged 2 months up to 16 years.
Culture and susceptibility studies should be performed to determine susceptibility of the causative organisms to cefepime. [Dosage and administration] SEFPIM can be administered by V/gtt and deep intramuscular injection. For adults and children >16 years of age or children of 40kg or >40kg, 1~2g/time, q12h, V/gtt. for 7~10 days; for mild or moderate urinary tract infections, 0.5~1g./time, q12h, V./gtt. or deep i.m. for 7~10 days; for severe urinary tract infections, 2g/time, q12h, V/gtt. for 10 days; for sever and life-threatening infections, V/gtt. 2gq8 h; for empirical treatment in febrile neutropenia complicated with fever, V/gtt. 2g/time, q8h, for 7~10 days or until neutropenia is controlled. If the fever is brought down while the level of neutrophilic granulocytes is till abnormally low, the use of antibiotic should be revaluated. The maximum dose for children of 2 months up to 12 years of age should not exceed that of adults (2g/time). Children >40kg may use dose of adults, usually 40mg/kg, V/gtt. q12h for 7~14 days; for children with bacterial meningitis, 50mg/kg, V/gtt. q8h; for neutropenic children, 50mg/kg, q12h ( fever in neutropenic children, q8h) with the same duration of treatment as the adults. Experience with the use of cefepime in pediatric patients <2 months of age is limited, while this experience attained in patients >2 months of age suggested that a dosage of 30mg/kg q12 or q8h may be considered for patients aged 1~2 months. Adjustment in dosage is not necessary in patients with impaired hepatic function. For patients with impaired renal function, the initial dose of cefepime is the same as in patients with normal renal function. The recommended doses of cefepime in patients with renal insufficiency are presented in the following table:
In patients undergoing haemodialysis, approximately 68% of the dose in the body at the start of dialysis will be removed during a 3-hour dialysis period. In patients undergoing continuous peritoneal dialysis cefepime may be given at the same doses as recommended for patients with normal renal function at a dosage interval of every 48 hours. The data of use of cefepime in children with impaired renal function is not available. Due to similar pharmacokinetics between children and adults, the dosage for adults with renal impairment is recommended for children with renal impairment. Intravenous administration is preferable for patients with severe or life-threatening infections. For use of V/gtt., dissolve 1~2g of cefepime in 50~100ml of 0.9%NaCl injection, 5% or 10% Dextrose injection, M/6 Sodium Lactate injection, a mixture of 0.5% and 0.9% Dextrose injection, a mixture of Lactate Ringer’s solution and 5% Dextrose injection. The concentration of cefepime should not be more than 40mg/ml, and be administered over a period of approximately 30 minutes. For use of IM, dissolve 0.5g of cefepime in 1.5ml, or 1g in 3.0ml of Water for Injection, 0.9% NaCl injection, 5% Dextrose injection and Bacteriostatic Water for Injection, then administered by deep IM injection into a large muscle mass (such as the upper outer quadrant of the gluteus maximus).
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