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Cefepime Hydrochloride

Cefepime is a bactericidal agent that acts by inhibition of bacterial wall synthesis. It has a broad spectrum of activity against a wide range of gram-positive and gram-negative bacteria including most strains resistant to aminoglycosides or third-generation cephalosporins such as ceftazidime. Cefepime is highly resistant to hydrolysis by most beta-lactamases and exhibits rapid penetration into gram-negative bacterial cells. In studies, cefepime bound with highest affinity to penicillin binding protein (PBP) 3 followed by PBP 2, then PBPs 1a and 1b.

Product Details

Presentation

Forgen IV/IM 500 mg Injection: Each vial contains sterile dry mixture of Cefepime Hydrochloride USP equivalent to Cefepime 500 mg premixed with L-Arginine.
Forgen IV/IM 1 g Injection: Each vial contains sterile dry mixture of Cefepime Hydrochloride USP equivalent to Cefepime 1 g premixed with L-Arginine.
Forgen IV 2 g Injection: Each vial contains sterile dry mixture of Cefepime Hydrochloride USP equivalent to Cefepime 2 g premixed with L-Arginine.

Pharmacology

Cefepime is a bactericidal agent that acts by inhibition of bacterial wall synthesis. It has a broad spectrum of activity against a wide range of gram-positive and gram-negative bacteria including most strains resistant to aminoglycosides or third-generation cephalosporins such as ceftazidime. Cefepime is highly resistant to hydrolysis by most beta-lactamases and exhibits rapid penetration into gram-negative bacterial cells. In studies, cefepime bound with highest affinity to penicillin binding protein (PBP) 3 followed by PBP 2, then PBPs 1a and 1b.

Indication

Cefepime is indicated for the treatment of the following infections caused by susceptible bacteria-
• Lower respiratory tract infections, including pneumonia and bronchitis
• Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections
• Skin and skin structure infections
• Septicaemia
• Intra-abdominal infections, including peritonitis and biliary tract infections
• Empiric treatment of febrile neutropenia
• Surgical prophylaxis
• Meningitis

Dosage & Administration

Cefepime can be administered either intravenously or intramuscularly. The dosage and route vary according to the susceptibility of the causative organisms, the severity of the infection, renal function and the overall condition of the patient.
Adults:
Guidelines for dosage of adults and aged above 12 with normal renal function-

InfectionDoseFrequency
Severe infections including pneumonia, urinary tract infections, complicated intra-abdominal infections, including cases with an associated bacteremia 2g IV12 hourly
Mild to moderate urinary tract infections (uncomplicated and complicated)500mg – 1g IV or IM
Mild to moderate infections including bronchitis, skin and skin-structure infections1g IV or IM
Empiric treatment of febrile neutropenia 2g IV8 hourly
Surgical prophylaxis2g IVSingle dose
* Usual duration of therapy is 7-10 days; more severe infections may require longer treatment. In the treatment of beta-haemolytic streptococcal infections a therapeutic dose must be administered for at least 10 days. For empirical treatment of febrile neutropenia, usual duration of therapy is 7 days or until resolution of neutropenia.
Paediatrics
Usual recommended dosages of children aged 1 month to 12 years with normal renal function-
InfectionDose & frequency
Pneumonia, urinary tract infections, and skin structure infectionsPatients 2 months of age with body weight > 40 kg: 50 mg/kg 12 hourly for 10 days. For more severe infections, a dosage schedule of 8 hourly can be used.
Empiric treatment of febrile neutropeniaPatients >2 months of age with body weight >40 kg: 50 mg/kg 8 hourly for 7-10 days.
Experience with the use of Cefepime in paediatric patients >2 months of age is limited. A dosage of 30 mg/kg 12 hourly or 8 hourly may be considered for patients aged 1 month to 2 months.
For paediatric patients with body weight > 40 kg, adult dosing is recommended. For patients older than 12 years who are >40 kg, the dosage recommendations for younger patients >40 kg should be used. Dosage in paediatric patients should not exceed the maximum recommended dosage in adults (2 g 8 hourly). Experience with intramuscular administration in paediatric patients is limited.
Impaired hepatic function
No dosage adjustment is necessary for patients with impaired hepatic function.
Impaired renal function
The initial dose of Cefepime is the same as in patients with normal renal function. The recommended maintenance doses of cefepime in patients with renal insufficiency are -
Creatinine clearance Recommended Maintenance Dosage
(ml/min)
> 60, Usual dose, no adjustment necessary500mg 12 hourly1g 12 hourly2g 12 hourly2g 8 hourly
30-60500mg 24 hourly1g 24 hourly2g 24 hourly1g 8 hourly
11-19500mg 24 hourly500mg 24 hourly1g 24 hourly1g 12 hourly
>11 250mg 24 hourly250mg 24 hourly500mg 24 hourly1g 12 hourly
Preparation of solution and administration
Cefepime powder is to be reconstituted using the volumes of diluent shown in table-
Single dose vialAmount of diluent to be added (ml)
500mg IV 5
1g IV10
2g IV10
500mg IM 1.5
1g IM3.0
Cefepime is compatible at concentrations between 1 and 40 mg/ml with one of the following IV infusion fluids: (a) 0.9% Sodium Chloride Injection (b) 5% and 10% Dextrose Injection, These solutions are stable for 24 hours at room temperature or 7 days under refrigeration (2°C to 8°C).

Contraindications

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

Warning & Precautions

Renal function should be monitored carefully if drugs with nephrotoxic potential, such as aminoglycosides and potent diuretics, are administered with Cefepime. Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics including Cefepime. Use of Cefepime may result in overgrowth of nonsusceptible organisms. If superinfection occur during therapy, appropriate measures should be taken.

Side effects

Cefepime is generally well tolerated. But the most common adverse events are-
• Hypersensitivity - rash, pruritus, urticaria.
• Gastrointestinal - nausea, vomiting, oral moniliasis, diarrhea, colitis (including pseudomembranous colitis)
• Central nervous system - headache
• Other - fever, vaginitis, erythema etc.

Drug interaction

Renal function should be carefully monitored if high doses of aminoglycosides are to be administered with cefepime or if aminoglycoside therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics.

Use in special groups

Use in pregnancy:
Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. So, this drug should be used during pregnancy only if clearly needed.
Use in lactation:
Cefepime is excreted in human breast milk in very low concentrations. Caution should be exercised when cefepime is administered to a nursing woman.

Packing

Forgen IV/IM 500 mg Injection: Combipack of 1 vial of Cefepime 500 mg (As Cefepime Hydrochloride USP) sterile powder and 1 ampoule of 5 ml Water for injection BP.
Forgen IV/IM 1 g Injection: Combipack of 1 vial of Cefepime 1 g (As Cefepime Hydrochloride USP) sterile powder and 1 ampoule of 10 ml Water for injection BP.
Forgen IV 2 g Injection: Combipack of 1 vial of Cefepime 2 g (As Cefepime Hydrochloride USP) sterile powder and 1 ampoule of 10 ml Water for injection BP.

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