Indications and Uses:
Tetracef® Injection is indicated in the treatment of the following infections:
Pneumonia (moderate to severe) Uncomplicated and Complicated Urinary
Tract Infections (including pyelonephritis) Uncomplicated Skin and Skin
Structure Infections Complicated Intra-abdominal Infections Empiric
Therapy for Febrile Neutropenic Patients
Contraindications:
Cefepime is contraindicated in patients who have shown hypersensitivity
reactions to the cephalosporin class of antibiotics, penicillins or other betalactam
antibiotics & any component of the formulation.
Dosage And Administration:
For Adults: Moderate to Severe Pneumonia due to S. pneumoniae, P. aeruginosa,
K. pneumoniae, or Enterobacter species: 1-2 g IV for every 12 hours for 10 days.
Empiric therapy for febrile neutropenic patients: 2 g IV for every 8 hours for 7
days. Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections,
including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis: 0.5-1 g
IV/IM for every 12 hours for 7-10 days. Severe Uncomplicated or Complicated
Urinary Tract Infections, including pyelonephritis, due to E. coli or K.
pneumoniae: 2 g IV for every 12 hours for 10 days. Moderate to Severe
Uncomplicated Skin and Skin Structure Infections due to S. aureus or S.
pyogenes: 2 g IV for every 12 hours for 10 days. Complicated Intra-abdominal
Infections (used in combination with metronidazole) caused by E. coli, viridans
group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B.
fragilis.: 2 g IV for every 12 hours for 7-10 days. 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
above.
Precautions:
In patients with impaired renal function (creatinine clearance <60 ml/min), the
dose of Cefepime should be adjusted. Cefepime should be prescribed with
caution in individuals with a history of gastrointestinal diseases, particularly
colitis.
Side Effects:
Generally Cefepime is well tolerated. However, few side-effects including rash,
pruritus, urticaria, fever, headache, nausea, vomiting, diarrhea, dizziness, oral
moniliasis may occur.
Use in Pregnancy & Lactation:
Pregnancy: There are no adequate and well-controlled studies of Cefepime use in
pregnant women. Cefepime should be used during pregnancy only if clearly
needed. Lactation: Cefepime is excreted in human breast milk in very low
concentrations. Caution should be exercised when Cefepime is administered to a
nursing woman
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