Cefepime Injection

1. What Tetracef® is and what it is used for?
Tetracef® (Cefepime) is a fourth generation broad-spectrum cephalosporin antibiotic. Cefepime acts by inhibition of bacterial cell wall synthesis. It is highly resistant to hydrolysis by most beta-lactamases and exhibits rapid penetration into gram-negative bacterial cells.

2. Before you take Tetracef®
Do not take this medicine and tell your doctor if:

Cefepime is contraindicated in patients who have shown hypersensitivity reactions to the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics & any component of the formulation.

Take special care with Tetracef®
Check with your doctor before taking this medicine if:

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.

Pregnancy and breast-feeding
Pregnancy: There are no adequate and well-controlled studies of Cefepime use in pregnant women. Cefepime pregnancy category USFDA B.
Lactation: Cefepime is excreted in human breast milk in very low concentrations. Caution should be exercised when Cefepime is administered to a nursing woman.

3. How to take Tetracef®?
Single-dose vial Administration Amount of WFI to be added: 500 mg IM in 1.5 ml, 500 mg IV in 5 ml, 1 g IM in 3 ml, 1 g IV in 10 ml, 2 g IV in 10 ml.
These solutions may be stored up to 24 hours at controlled room temperature or not more than 7 days in a refrigerator.

How much to take?
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.

If you take more Tetracef® than you should
If you have too much of this medicine, talk to your doctor straight away.

If you forget to take Tetracef®
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose

If you stop taking Tetracef®
Do not stop taking this medicine without talking to your doctor. You should not stop taking Tetracef® just because you feel better. This is because the problem may come back or get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Tetracef® can cause side effects, although not everybody gets them.

Generally Cefepime is well tolerated. However, few side-effects including rash, pruritus, urticaria, fever, headache, nausea, vomiting, diarrhea, dizziness, oral moniliasis may occur.

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

5. How to store Tetracef®?
Store in a cool and dry place, away from light. Keep out of reach of children

Tetracef Prescribing Information

Located in: Anti-infectives