Classes
DEA Class; Rx
Common Brand Names; Maxipime
- Cephalosporins, Other
Description
Parenteral fourth-generation cephalosporin. Pharmacokinetics and spectrum of activity similar to ceftazidime. Clinical uses are similar to those of the third-generation cephalosporins.
Indications
Indicated for Treatment of moderate-to-severe pneumonia.
Empiric therapy in febrile neutropenic patients.
Treatment of uncomplicated and complicated urinary tract infections (UTIs), including pyelonephritis.
Treatment of uncomplicated skin and skin structure infections
Treatment of complicated intra-abdominal infections; use in combination with metronidazole
Contraindications
Documented hypersensitivity to cefepime, penicillins, or other beta-lactam antibiotics
Adverse Effects
- Positive Coombs test result without hemolysis (16%)
- Rash (1-4%)
- Elevated alanine aminotransferase (3%)
- Hypophosphatemia (3%)
- Diarrhea (<3%)
- Eosinophilia (2%)
- Erythema at injection site (2%)
- Normal partial thromboplastin time (PTT) (2%)
- Nausea or vomiting (<2%)
- Fever (1%)
- Headache (1%)
- Pain (1%)
- Pruritus (1%)
- Agranulocytosis
- Anaphylactic shock
- Anaphylaxis
- Coma
- Encephalopathy
- Hallucinations
- Leukopenia
- Myoclonus
- Neuromuscular excitability
- Neutropenia
- Seizures
- Thrombocytopenia
Warnings
IM recommended only for mild-to-moderate complicated or uncomplicated UTI due to E coli
Prescribing drug in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria
Prolonged use may cause superinfection
May increase international normalized ratio (INR) with prolonged treatment, especially in nutritionally deficient patients
Caution warranted with history of previous immediate hypersensitivity reactions to cefepime, cephalosporins, penicillins, or other drugs; exercise caution if product is to be given to penicillin-sensitive patients; cross-hypersensitivity among beta-lactam antibacterials documented to occur up to 10% of patients with history of penicillin allergy; if allergic reaction to this drug occurs, discontinue drug and institute appropriate supportive measures
Use with caution in patients with GI disease, particularly colitis
If CrCl <60 mL/min, adjust dosage to compensate for slower renal elimination rate
Pregnancy and Lactation
There are no cases of drug exposure during pregnancy reported from postmarketing experience or from clinical trials; available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes
Drug is present in human milk at low concentration (0.5 mcg/mL); a nursing infant consuming approximately 1000 mL of human milk per day would receive approximately 0.5 mg of cefepime per day
Maximum Dosage
6 g/day IV or 2 g/day IM.
6 g/day IV or 2 g/day IM.
150 mg/kg/day IV (Max: 6 g/day) or 100 mg/kg/day IM (Max: 2 g/day).
150 mg/kg/day IV (Max: 6 g/day) or 100 mg/kg/day IM (Max: 2 g/day).
2 to 11 months: 150 mg/kg/day IV or 100 mg/kg/day IM.
1 month: Safety and efficacy have not been established; however, doses up to 150 mg/kg/day IV or 100 mg/kg/day IM have been used off-label.
Neonates 36 weeks gestation and older: Safety and efficacy have not been established; however, doses up to 100 mg/kg/day IV have been used off-label.
Neonates less than 36 weeks gestation: Safety and efficacy have not been established; however, doses up to 60 mg/kg/day IV have been used off-label.
How supplied
Cefepime
infusion solution
- 1g/50mL
- 2g/100mL
powder for injection
- 1g
- 2g