Preparation
Magnova 500 mg IM/IV injection: Each vial contains Cefepime 500 mg as Cefepime Hydrochloride USP buffered with L-Arginine sterile powder and each ampoule contains 5 ml water for injection BP.
Magnova 1 gm IM/IV injection: Each vial contains Cefepime 1 gm as Cefepime Hydrochloride USP buffered with L-Arginine sterile powder and each ampoule contains 10 ml water for injection BP.
Magnova 2 gm IV injection: Each vial contains Cefepime 2 gm as Cefepime Hydrochloride USP buffered with L-Arginine sterile powder and each ampoule contains 20 ml water for injection BP
Official Specification
Fourth Generation Cephalosporin Antibiotic
Indication
Moderate to severe Pneumonia, Empiric therapy for febrile neutropenic, Mild to moderate Uncomplicated or Complicated Urinary Tract Infections including pyelonephritis, Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, Moderate to severe Uncomplicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections (used in combination with metronidazole)
Contraindication
The recommended adult and pediatric dosages and routes of administration are outlined in the following table. Magnova (Cefepime) should be administered intravenously over approximately 30 minutes. Before administration ensure that the powder has been fully dissolved in the solution.
Adults:
Moderate to severe Pneumonia due to S. pneumoniae, P. aeruginosa, K. pneumoniae, or Enterobacter species: Dose 1 - 2 gm IV, Frequency Every 12 hours, Duration 10 days.
Empiric therapy for febrile neutropenic patients Dose 2 gm IV, Frequency Every 8 hours, Duration 7 days.
Mild to moderate Uncomplicated or Complicated Urinary Tract Infections including pyelonephritis, due to E. coli, K. pneumoniae or P. mirabilis, Dose 500 mg - 1 gmIV/IM, Frequency Every 12 hours, Duration 10 days.
Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E- coli or K. pneumoniae, Dose 2 gm IV, Frequency Every 12 hours, Duration 10 days
Moderate to severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes, Dose 2 gm IV, Frequency Every 12 hours, Duration 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, Dose 2 gm IV, Frequency Every 12 hours, Duration 7-10 days.
Pediatrics (aged 2 months up to 12 years) Usual recommended dosages:
Pneumonia, Urinary Tract Infections and Skin and Skin Structure Infections: 50 mg/kg every 12 hours (body weight < 40 kg). For more severe infections, a dosage schedule of every 8 hours can be used. Empiric treatment of febrile neutropenia: 50 mg/kg every 8 hours.The usual duration of therapy is 7-10 days; however, more severe infections may require longer treatment.
Dosage & Administration
Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to any component of the formulation (including L-Arginine), the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.
Side Effect
Less than 10% patient have positive Coombs\' test without hemolysis and 0.1% to 10% patients have fever, headache, rash, pruritus, diarrhea, nausea and vomiting. After administered the injection, localized pain, erythema could be occur at injection site.
Precaution
In patients with impaired renal function (creatinine clearance <50 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.
Drug Interaction
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
Pregnancy: Category B. There are no adequate and well-controlled studies of Cefepime use in pregnant women. Cefepime should be used during pregnancy only if clearly needed.Nursing Mothers: Cefepime is excreted in human breast milk in very low concentrations (0.5 ug/mL). Caution should be exercised when Cefepime is administered to a nursing woman.
Presentation
Magnova 500 mg IM/IV Injection: Pack of 1 vial containing Sterile Cefepime Hydrochloride USP equivalent to Cefepime 500 mg premixed with L-Arginine accompanied by one ampoule of 5 ml water for injection BP, a 5 ml disposable syringe, a baby needle, an alcohol pad & a first aid band.
Magnova 1 gm IM/IV Injection: Pack of 1 vial containing Sterile Cefepime Hydrochloride USP equivalent to Cefepime 1 gm premixed with L-Arginine accompanied by one ampoule of 10 ml water for Injection BP, a 10 ml disposable syringe, a butterfly needle, an alcohol pad & a first aid band.
Magnova 2 gm IV Injection: Pack of 1 vial containing Sterile Cefepime Hydrochloride USP equivalent to Cefepime 2 gm premixed with L-Arginine accompanied by one ampoule of 20 ml water for Injection BP, a 20 ml disposable syringe, a butterfly needle, an alcohol pad & a first aid band.
