Description

Cefepime dihydrochloride monohydrate is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration.

Composition

Each vial contains :

• Cefepime: 1000 mg.
• Excipients: S.Q. for one vial.

Indications

Acepime (Cefepime dihydrochloride monohydrate) is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms:

• Pneumonia (moderate to severe) caused by Stretococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
• Empiric Therapy for Febrile Neutropenic Patients. Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate.
• Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae.
• Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.
• Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, virdans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

Dosage & Administration

Moderate to Severe Pneumonia:

1- 2 g  IV, every 12h , for 10 days.

Empiric Therapy for Febrile Neutropenic Patients:

2 g IV , every 8h , for 7 days.

Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis:

0.5- 1g , IV/ IM, every 12h , for 7- 10 days.

Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis:

2 g IV , every 12h , for 10 days.

Moderate to Severe Uncomplicated Skin and Skin Structure Infections:

2 g IV, every 12h, for 10 days.

Complicated Intra-abdominal Infections (used in combination with metronidazole, separately):

2 g IV, every 12h , for 7- 10 days.

Impaired Renal Function:

The recommended initial dose of Acepime should be the same as in patients with normal renal function. The recommended maintenance doses of Acepime in patients with renal insufficiency are presented in the following table:

Recommended Maintenance Schedule in Adult Patients with Renal Impairment Relative to Normal Recommended Dosing Schedule:

In patients undergoing hemodialysis, 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, Acepime may be administered at normally recommended doses at a dosage interval of every 48 hours.

Administration:

For Intravenous Use:

For IV administration, the vials 500mg,  1g, or 2g should be constituted by adding the appropriate volumes, as shown below, of one of the following IV fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection , 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˚- 30˚ C or 7 days in a refrigerator 2˚- 8˚ C. The resulting solution should be administered over approximately 30 minutes

Intramuscular  Administration:

For IM administration, Acepime (Cefepime dihydrochloride monohydrate) should be reconstituted, as shown below, with one of the following diluents: Sterile Water for Injection, 0.9% sodium chloride, 5% dextrose injection, 0.5% or 1.0% lidocaine hydrochloride, or sterile bacteriostatic water for injection with parabens or benzyl alcohol. The resulting solutions are stable for 24 hours at controlled room temperature 20˚-25˚ C or for 7 days in a refrigerator 2˚- 8˚ C.

Preparation of Solutions of Acepime:

Note: Parenteral drugs should be inspected visually for particulate matter before administration.