COMPOSITIONS :
Cefepime HCl Monohydrate Powder for Injection 1 g, each vial contains : Cefepime HCl Monohydrate and Arginine sterile equivalent to Cefepime 1 g.
DESCRIPTIONS :
Cefepime HCl Monohydrate containing Cefepime HCl Monohydrate and Arginine sterile (equivalent to Cefepime) which is available in powder for injection 1 g.
INDICATIONS :
Cefepime HCl Monohydrate is indicated for :
- Uncomplicated and complicated urinary tract infections.
- Uncomplicated skin and structure skin infections.
- Lower respiratory tract infections (pneumonia and bronchopneumonia).
- Empiric treatment in febrile neutropenic patients.
- Complicated intra-abdominal infections.
DOSAGE AND ADMINISTRATIONS :
Adult dose is generally 1 g of Cefepime, administered IV or IM every 12 hours.
| Infection type | Dosage | Frequency | Duration (days) |
| Uncomplicated and complicated mild to moderate urinary tract infections including pyelonephritis | 0,5 – 1 g
IV/IM |
Every 12 hours | 7 – 10 |
| Uncomplicated and complicated severe urinary tract infections including pyelonephritis | 2 g IV | Every 12 hours | 10 |
| Moderate to severe pneumonia | 1 – 2 g IV | Every 12 hours | 10 |
| Uncomplicated moderate to severe skin and skin structure infections | 2 g IV | Every 12 hours | 10 |
| Empiric treatment in febrile neutropenic patients | 2 g IV | Every 8 hours | 7 |
| Complicated intra-abdominal infections
(combinated with Metronidazole) |
2 g IV | Every 12 hours | 7 – 10 |
Children (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 structure skin infections, pneumonia and as empiric therapy for febrile neutropenic patients is 50 mg/kg/dose, administered every 12 hours (every 8 hours for febrile neutropenic patients), duration of therapy as presented in table above.
The recommended maintenance dose for adult patients with renal impairment which is relative with the recommended maintenance dose for normal patients :
| Creatinine clereance
(ml/minute) (ml/menit) |
Recommended maintenance dosage | |||
| > 60 recommended dose for normal patients | 500 mg every 12 hours | 1 g every 12
hours |
2 g every 12
hours |
2 g every 8
hours |
| 30 – 60 | 500 mg every 24 hours | 1 g every 24
hours |
2 g every 24
hours |
2 g every 12
hours |
| 11 – 29 | 500 mg every 24 hours | 500 mg every 24 hours | 1 g every 24
hours |
2 g every 24
hours |
| < 11 | 250 mg every 24 hours | 250 mg every 24 hours | 500 mg every 24 hours | 1 g every 24
hours |
Administrations :
- IV Infusion : Reconstitute the 1 g vial with 10 ml infusion fluids of Sodium Chloride 0.9% and add the reconstituted solution into infusion fluids container of Sodium Chloride 0.9% that have been used. The resulting solution should be administered over approximately 30 minutes.
- IM Injection : Reconstitute the 1 g vial with 2.4 ml of Sterile water for injection.
- The reconstituted solution is stable for 24 hours at temperature below 25°C or for 7 days in a refrigerator (2 – 8)°C.
OVERDOSAGE :
In case of severe overdosage, especially in patient with compromised renal function, dialysis will aid in the removal of Cefepime from the body, hemodialysis is preferred to peritoneal dialysis.
CONTRAINDICATIONS :
Patient who have shown immediate hypersensitivity reactions to any component of Cefepime, the Cephalosporin class of antibiotics, Penicillins or other β-lactam antibiotics.
WARNINGS AND PRECAUTIONS :
- Because high and prolonged serum antibiotic concentration can occur from the usual dosages in patients with renal insufficiency or other conditions that may compromise renal function, the maintenance dosage should be reduced when Cefepime is administered to such patients.
- Antibiotics should be administered with caution to any patient who have demonstrated some form of allergy, particularly to drugs. If an allergic reaction to Cefepime occurs, discontinue the drug.
- Pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics.
- Renal function should be monitored carefully if drugs with nephrotoxic potential e.g., Aminoglycosides and potent diuretics, are administered with Cefepime.
- As with other antibiotics, use of Cefepime may result in overgrowth of non susceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken.
- Cefepime should be used during pregnancy only if clearly needed.
- Cefepime is excreted in human breast milk in very low concentrations. Caution should be used when Cefepime is administered to nursing women.
- Use in children : The efficacy of Cefepime in children < 13 years has not been established.
- Use in the elderly : Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and renal function should be monitored.
DRUG INTERACTIONS :
Solutions of Cefepime, like those of the most β-lactam antibiotics, should not be added to solutions of Ampicillin at a concentration > 40 mg/ml, Metronidazole, Vancomycin, Gentamicin, Tobramycin, Netilmicin sulfate or Aminophylline because of potential interaction. However if concurrent therapy with Cefepime is indicated, each of these antibiotics can be administered separately.
ADVERSE REACTIONS :
- Hypersensitivity : Rash, pruritus and fever.
- Gastrointestinal effect : Diarrhea, nausea, vomiting, constipation, abdominal pain, dyspepsia.
- Cardiovascular effect : Chest pain and tachycardia.
- Respiratory effect : Cough, pain in the throat and dyspnea.
- Central Nervous System (CNS) effect : Headache, dizziness, insomnia, paresthesia, anxiety and confusion.
- Others : Asthenia, sweating, vaginitis, peripheral edema, pain and back pain.
- Local reactions e.g., phlebitis and inflammation at the site of IV injection.
- The following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics : Urticaria, Steven-Johnson syndrome, erythema multiforme, toxic epidermal
necrolysis, colitis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, seizures, encephalopathy, myoclonus and renal function; hepatic dysfunction including cholestasis and false-positive tests for urinary glucose.
PRESENTATIONS :
Cefepime HCl Monohydrate Powder for Injection 1 g Box, 10 vial @ 1 g Reg. No. : GKL0702339844A1
STORAGE :
STORE BELOW 25°C AND DRY PLACE, PROTECT FROM LIGHT
The reconstituted solution is stable for 24 hours at temperature below 25°C or for 7 days in a refrigerator (2 – 8)°C.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
