COMPOSITIONS :
Imipex® IV Powder for Infusion 1 g, each bottle contains : Imipenem monohydrate equivalent to Imipenem 500 mg and Cilastatin sodium equivalent to Cilastatin 500 mg.
DESCRIPTIONS :
Imipex® with active ingredient Imipenem monohydrate (equivalent to Imipenem) and Cilastatin sodium (equivalent to Cilastatin) are available in 1 g of sterile powder for infusion in bottle pack.
INDICATIONS :
- Treatment :
Imipex® is indicated for the treatment of infections caused by susceptible microorganisms in the conditions listed below :
- Intra-abdominal infections.
- Lower respiratory tract infections.
- Gynecological infections.
- Septicemia
- Genitourinary tract infections.
- Bone and joint infections.
- Skin and soft tissue infections.
Imipex® is not indicated for the treatment of meningitis.
- Prophylaxis :
Imipex® is indicated for the prevention of certain post-operative infections in patient undergoing contaminated surgical procedures or where the occurrence of post-operative infection could be especially serious.
DOSAGE AND ADMINISTRATIONS :
The dosage recommendations for Imipex® represent the quantity of Imipenem to be administered. An equivalent amount of Cilastatin is also present. The total daily dosage and route administration of Imipex® should be based on the type of severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen (s), renal function and body weight. Doses cited are based on body weight of 70 kg.
ADULTS :
- Treatment :
Most infections respond to a daily dose of 1 − 2 g administered in 3 − 4 divided doses (see Table 1). For the treatment of moderate infection, a 1 g twice daily dosage regimen may also be used. In infections due to less susceptible organisms, the daily dosage of Imipex® may be increased to a maximum of 4 g/day or 50 mg/kg/day, whichever is lower.
Each 250 mg or 500 mg dose of Imipex® should be given by intravenous infusion over 20 to 30 minutes. Each 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.
Table 1. Adult dosage of Imipex®
| Severity of infection | Dose
(mg of Imipenem) |
Dosage interval | Total daily dosage |
| Mild | 250 mg | 6 hours | 1 g |
| Moderate | 500 mg
1000 mg |
8 hours
12 hours |
1.5 g
2 g |
| Severe – fully susceptible | 500 mg | 6 hours | 2 g |
| Severe and/or life threatening due to less
susceptible organisms (primarily some strains of P. aeruginosa) |
1000 mg
1000 mg |
8 hours
6 hours |
3 g
4 g |
Due to high antimicrobial activity of Imipex®, it is recommended maximum total daily dosage not exceed 50 mg/kg/day or 4 g/day, whichever is lower. However, cystic fibrosis patients with normal renal function have been treated with Imipex® at doses up to 90 mg/kg/day in divided dose, not exceeding 4 g/day.
- Prophylaxis :
For prophylaxis against post-surgical infections in adults, 1000 mg Imipex® should be given intravenously on induction of anesthesia and 1000 mg 3 hours later.
For high risk (e.g., colorectal) surgery, two additional 500 mg doses can be given at 8 and 16 hours after induction.
- Patient with renal insufficiency :
As in patient with normal renal function dosing is based on the severity of the infection. The maximum dosage of Imipex® for patients with various degrees of renal function impairment is shown in table 2. Doses cited are based on a body weight of 70 kg.
Proportionate reduction in dose administered should be made for patients with lower body weight.
Table 2. Maximum dosage Imipex® in relation to renal function
| Renal function (creatinine clearance ml/minute/1.73m2) | Dose (mg) | Dosage interval
(hours) |
Maximum total daily dosage (g)* |
| Mild impairment
31 − 70 |
500 | 6 − 8 | 1.5 − 2 |
| Moderate impairment
21 − 30 |
500
|
8 − 12 | 1 − 1.5 |
| Severe **impairment
0 − 20 |
250 − 500 | 12 | 0.5 − 1.0 |
Note :
* = The higher dosage should be reserved for infections due to less susceptible organisms.
** = Patients with creatinine clearance of 6 to 20 ml/minute/1.73m2 should be treated with 250 mg (or 3.5 mg/kg whichever is lower) every 12 hours for must pathogens. When the 500 mg dose is used in these patients, there may be an increased risk of seizures. Patients with creatinine clearance of ≤ 5 ml/minute/1.73m2 should not receive Imipex®. Unless hemodialysis is instituted within 48 hours.
Both Imipenem and Cilastatin are cleared from the circulation during hemodialysis. The patients should receive Imipex® after hemodialysis and at 12 hours intervals timed from the end of that hemodialysis session. Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, Imipex® is recommended only when the benefit outweights the potential risk of seizures.
Currently there are inadequate data to recommend use of Imipex® for patients on peritoneal dialysis. Renal status of elderly patients may not be accurately portrayed by measurement of BUN or creatinine alone. Determination of creatinine clearance is suggested to provide guidance for dosing in such patients.
PEDIATRIC :
Safety and effectiveness in children below 12 years have not been established.
RECONSTITUTION INTRAVENOUS SOLUTION
- Imipex® for intravenous infusion is supplied as a sterile powder in bottles containing 500 mg Imipenem and 500 mg Cilastatin equivalent.
- Imipex® is buffered with sodium bicarbonate to provide solutions in the pH range of 6.5 to 7.5. There is no significant change in pH when solution are prepared and used as directed.
- Imipex® 500 contains 37.5 mg of Sodium (1.6 mEq).
- Sterile powder Imipex® should be reconstituted as shown in table 3. It should be shaken until a clear solution is obtained. Variations of color, from colorless to yellow, do not affect the potency of the product.
Table 3. Reconstitution of Imipex®
| Dose IV Imipex®
(mg of Imipenem) |
Volume of diluent
(ml)
|
Approximate average Concentration of IV
(mg/ml of Imipenem) |
| 500 | 100 | 5 |
- Reconstitution instruction :
Imipex® IV can be reconstituted by adding one of the appropriate diluents (see stability of reconstituted of Imipex®) to the mark (100 ml), and then shake well until completely dissolved.
- Stability of reconstituted of Imipex® :
| Diluent | Stability period | |
| Cool temperature (25°C) | Refrigeration (5°C) | |
| Isotonic Sodium Chloride | 10 hours | 48 hours |
| Dextrose 5% in water | 4 hours | 24 hours |
CAUTION : Imipex® is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. Imipex® can be administered, however, into an IV system through which a lactate solution is being infused.
Imipex® should not be mixed with or physical added to other antibiotics.
CONTRAINDICATION :
Patients who have shown hypersensitivity to any component of this product.
WARNINGS AND PRECAUTIONS :
- Patients known to be hypersensitive to Penicillins, Cephalosporins or other beta-lactams because of the possibility of cross-allergenicity.
- Caution in patient with a history of gastrointestinal disease, particularly colitis. It is important to consider a diagnosis of pseudomembranous colitis in patient with develop diarrhea is association with antibiotic use. While studies indicate that a toxin produced by Clostridium difficile is primary cause of antibiotics associated colitis, other cause should also be considered.
- Prolonged use of Imipenem − Cilastatin may result in overgrowth of nonsusceptible organisms.
- Use in pregnancy : Imipenem − Cilastatin should be used during pregnancy only if clearly needed.
- Use in nursing woman : Imipenem − Cilastatin is deemed essential, the patients should stop nursing.
- Patients with CNS disorders : CNS side effects such as myoclonic activity, confusional states or seizures have been reported. If focal tremors, myoclonus or seizures occur, patients should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted. If CNS symptoms continue, the dosage of Imipenem − Cilastatin should be decreased or discontinued.
- Patients with creatinine clearance of ≤ 5 ml/minute/1.73m2 should not receive Imipenem − Cilastatin unless hemodialysis is instituted within 48 hours. Imipenem − Cilastatin is recommended only when the benefit outweights the potential risk of seizures.
PRESENTATION :
Imipex® IV Powder for Infusion 1 g Box, 1 bottle @ 1 g Reg. No. DKL1202346780A1
STORAGE :
STORE BELOW 25oC AND DRY PLACE
After reconstitution, Imipex® IV with Isotonic Sodium Chloride diluent can be stored up to 10 hours at cool temperature (25ºC) and 48 hours at refrigeration (5ºC). Meanwhile, Imipex® IV with Dextrose 5% in water can be stored up to 4 hours at cool temperature (25ºC) and 24 hours at refrigeration (5ºC).
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
