Cepiram Dosage/Direction for Use

The recommended adult and pediatric dosages and routes of administration are outlined in the following table. Cefepime hydrochloride (Cepiram) should be administered intravenously over approximately 30 minutes. (See Table 5.)

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Pediatric Patients (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients), for durations as given previously or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently.
Patients with Hepatic Impairment: No adjustment is necessary for patients with hepatic impairment.
Use in Patients with Renal Impairment: In patients with impaired renal function (creatinine clearance less than or equal to 60 mL/min), the dose of Cefepime hydrochloride (Cepiram) should be adjusted to compensate for the slower rate of renal elimination. The recommended maintenance doses of Cefepime hydrochloride (Cepiram) in patients with renal insufficiency are presented in Table 6. (See Table 6.)

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When only serum creatinine is available, the following formula (Cockroft and Gault equation) may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function: see equation.

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Administration: For Intravenous Infusion, Constitute the 500 mg, 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an IV container with one of the compatible IV fluids. THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES.
Intramuscular Administration: For intramuscular administration, Cefepime hydrochloride (Cepiram) should be constituted with one of the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1% Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection. Preparation of Cepiram solutions is summarized in Table 7. (See Table 7.)

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Compatibility and Stability: Intravenous: Cepiram is compatible at concentrations between 1 mg per mL and 40 mg per mL with the following intravenous infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection. These solutions may be stored up to 24 hours at controlled room temperature 20°C to 25°C (68°F to 77°F) or 7 days in a refrigerator 2°C to 8°C (36°F to 46°F).
Intramuscular: Cepiram constituted as directed is stable for 24 hours at controlled room temperature 20°C to 25°C (68°F to 77°F) or for 7 days in a refrigerator 2°C to 8°C (36°F to 46°F) with the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol, or 0.5% or 1% Lidocaine Hydrochloride.
Appearance and color of solution: colorless to amber.