AXERA Cefepime Hydrochloride 2g Powder for IM/IV Injection 30mL

For the treatment of the following infections caused by susceptible microorganisms: Lower respiratory tract infections, including pneumonia (moderate to severe) and bronchitis.
Uncomplicated and complicated urinary tract infections (UTIs), including pyelonephritis.
Skin and skin structure infections.
Complicated intra-abdominal infections, including peritonitis and biliary tract infections.
Empiric therapy for febrile neutropenic patients.
Septicemia.

 

For IV or IM administration.
Dosage and route of administration should be determined by the severity of infection, susceptibility of the causative organisms and the patient's condition. The IV route is preferable for patients with severe or life-threatening infections, particularly if the possibility of shock is present. (See Table 3.)

Dose in Adults with Renal Impairment: Initial Dose: The same as in patients with normal renal function except in patients undergoing hemodialysis.
Adjust cefepime maintenance dose to compensate for the slower rate of renal elimination.
When only serum creatinine is available, the following formula may be used to estimate creatinine clearance in adults. Serum creatinine should represent a steady state of renal function: See Equation 1.

Dose in Children with Renal impairment: Data is not available on dosing in children with renal impairment; however, reduction in dose and increase in dosing interval may follow the same recommendations for adults.
When only serum creatinine is available, creatinine clearance in children may be estimated using either of the following methods: See Equation 2.

Or, as prescribed by a physician.

Careful inquiry should be made concerning previous immediate hypersensitivity to cephalosporins, penicillins, or other drugs before initiating therapy with cefepime. If cefepime is given to penicillin-sensitive patients, caution should be exercised since cross-hypersensitivity among beta-lactam antibiotics has been clearly documented. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, IV fluids and IV antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with the use of nearly all antibacterial agents, including cefepime, and may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
Since high or prolonged serum cefepime concentrations can occur if usual dosage is used in patients with renal impairment or other conditions that may compromise renal function, the maintenance dosage of cefepime should be decreased in patients with renal impairment (i.e., creatinine clearance 60 mL/minute or less). Continued dosage should be determined by the degree of renal impairment, severity of infection and susceptibility of the causative organisms.
Serious adverse events, including life-threatening or fatal encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, and seizures and/or renal failure, have been reported in patients receiving cefepime during postmarketing surveillance. Most cases occurred in patients with renal impairment who received cefepime dosage that exceeded the recommended dosage schedules. However, some cases of encephalopathy occurred in patients who received dosage adjusted for renal impairment. In most patients, symptoms of neurotoxicity were reversible and resolved after discontinuance of cefepime and/or after hemodialysis.
If seizures associated with cefepime therapy occur, the drug should be discontinued.
Antimicrobial monotherapy may not be appropriate in patients at high risk of severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying malignancy, or with severe or prolonged neutropenia). Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk are those with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
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 development of drug-resistant bacteria.
As with other antibacterial agents, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.

The following adverse effects have also been reported for cephalosporin-class antibiotics: Hypersensitivity reactions including eosinophilia, joint pain or inflammation, edema, facial edema, genital and anal pruritus, angioedema, shock, hypotension, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, and exfoliative dermatitis; anaphylaxis including a few fatalities; thrombocythemia, leukocytosis, granulocytosis, monocytosis, lymphocytopenia, basophilia, anemia, aplastic anemia, pancytopenia, hemolytic anemia, epistaxis or hemorrhage; renal dysfunction, toxic nephropathy; vaginal candidiasis, menstrual irregularities; transient increase in γ-glutamyl transferase concentration; increased serum bilirubin and/or lactate dehydrogenase; decreased serum albumin and/or total protein; hepatic dysfunction including cholestasis; thrombophlebitis; malaise, fatigue, nightmares, vertigo, hyperactivity, nervousness or anxiety, agitation, hallucinations, insomnia, somnolence, weakness, hot flushes, alteration in color perception, confusion, hypertonia; chest pain, pleural effusion, pulmonary infiltrate, respiratory distress, cough, rhinitis; increased or decreased serum glucose concentration.

Action

Cephalosporins