Cefepime is a fourth-generation cephalosporin antibiotic. Cefepime has an extended spectrum of activity against Gram-positive and Gram-negative bacteria, with greater activity against both Gram-negative and Gram-positive organisms than third-generation agents.
Each combipack contains:
One Vial of Cefepime Hydrochloride USP eq. to Cefepime 1 gm.
(Sterile Mixture of Cefepime Hydrochloride USP and L-Arginine USP)
One 10 ml Ampoule of Sterile water for Injection USP.
Tvaxipim should be used with the following indications:
Tvaxipim is indicated in the treatment of the infections listed below when caused by susceptible bacteria. Culture and susceptibility studies should be performed to determine susceptibility of the causative organism(s) to cefepime:
Indicated in paediatric patients (2 months and older) for the treatment of the infections listed below when caused by susceptible bacteria, (when P. aeruginosa is isolated or suspected, combination therapy with an aminoglycoside should be used):
Tvaxipim can be administered either intravenously or intramuscularly.
The dosage and route vary according to the susceptibility of the causative organisms, the severity of the infection, and the overall condition and renal function of the patient.
Recommended dosage for Adults with Normal Renal Function aged 12 years and older:
Mild to moderate urinary tract infections (uncomplicated and complicated) – 500 mg – 1g, IV or IM, q12h.
Mild to moderate infections including bronchitis, skin and skin-structure infections – 1g, IV or IM, q12h.
Severe infections including pneumonia, urinary tract infections, complicated intra-abdominal infections, including cases with an associated bacteremia – 2g, IV, q12h.
Empiric treatment of fever in neutropenic patients – 2g, IV, q 8h.
Usual duration of therapy is 7-10 days; more severe infections may require longer treatment. In the treatment of betahaemolytic streptococcal infections, a therapeutic dose must be administered for at least 10 days. For empirical treatment of Febrile neutropenia, usual duration of therapy is 7 days or until resolution of neutropenia.
Paediatrics (aged 1 month up to 12 years with normal renal function):
Usual Recommended dosages:
Pneumonia, urinary tract infections, and skin structure infections: Patients 2 months of age with body weight <40 kg: 50 mg/kg q 12 h for 10 days. For more severe infections, a dosage schedule of q 8 h can be used.
Empiric treatment of febrile neutropenia: Patients >2 months of age with body weight <40 kg: 50 mg/kg q8h for 7-10 days.
Experience with the use of Tvaxipim in paediatric patients <2 months of age is limited. While this experience has been attained using the 50 mg/kg dose, modelling of pharmacokinetic data obtained in patients >2 months of age suggests that a dosage of 30 mg/kg q12h or q8h may be considered for patients aged 1 month up to 2 months.
Administration of Tvaxipim in these patients should be carefully monitored.
For paediatric patients with body weights > 40 kg, adult dosing recommendations apply. For patients older than 12 years who are <40 kg, the dosage recommendations for younger patients <40 kg should be used. Dosage in paediatric patients should not exceed the maximum recommended dosage in adults (2g q 8 h). Experience with intramuscular administration in paediatric patients is limited.
Elderly: Dose adjustment is not required, unless there is concurrent renal impairment.
Impaired hepatic function: No adjustment is necessary for patients with impaired hepatic function.
Impaired renal function:
The recommended maintenance doses of cefepime in patients with renal insufficiency:
Creatinine clearance (mL/min) Recommended Maintenance Dosage > 50 Usual doses, no adjustment necessary 2g q 8h, 2g q12h, 1g q 12h, 500 mg q 12h. 30 – 50 1g q 8h, 2g q 24h, 1g q 24h, 500 mg q 24h. 11 – 29 1g q 12h, 1g q 24h, 500 mg q 24h,500 mg q 24h. <10 1g q 24h, 500 mg q 24h, 250 mg q 24h, 250 mg q 24h.
In patients undergoing haemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. A repeat dose, equivalent to the initial dose, should be given at the completion of each dialysis session. In patients undergoing continuous ambulatory peritoneal dialysis, cefepime may be administered at the same doses recommended for patients with normal renal function, i.e., 500 mg, 1g or 2g depending on infection severity, but at a dosage interval of every 48 hours.