COMPOSITIONS :
Macef® Powder for Injection 1 g, each vial contains : Cefepime HCl and Arginine sterile equivalent to Cefepime 1 g.
DESCRIPTIONS :
Macef® containing Cefepime HCl and Arginine sterile (equivalent to Cefepime) which is available in powder for injection 1 g.
INDICATIONS :
Macef® 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 injectio
- 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 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.
PRESENTATION :
Macef® Powder for Injection 1 g Box, 1 vial @ 1 g + 1 ampoule solvent @ 10 ml
Reg. No. DKL0602338144A1
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 :
PT. BERNOFARM
Sidoarjo – Indonesia
