Pregnancy Cat

Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.

Precautions

Prescribing Cefepime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antimicrobials, prolonged use of Cefepime may result in overgrowth of non susceptible microorganisms. Repeated evaluation of the patient's condition is essential.
Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk.
Cefepime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of Cefepime. The effect of lower doses is not presently known.

Overdose Effects

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

Drug Classes

Fourth generation Cephalosporins

Storage Conditions

Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Composition

n/a

Mode Of Action

Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).

Reconstitution

For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV 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.Intramuscular: Cefepime is compatible with the following diluent such as: 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. 500 mg (IV) vials for intravenous administration:

Amount of WFI to be added: 5 ml
Approximate available volume: 5.6 ml

500 mg (IM) vials for intramuscular administration:

Amount of WFI to be added: 1.3 ml
Approximate available volume: 1.8 ml 

1 gm (IV) vials for Intravenous administration:

Amount of WFI to be added: 10 ml
Approximate available volume: 11.3 ml

1 gm (IM) vials for intramuscular administration:

Amount of WFI to be added: 2.4 ml
Approximate available volume: 3.6 ml

2 gm (IV) vials for Intravenous administration:

Amount of WFI to be added: 10 ml
Approximate available volume: 12.5 ml