Imipenem + Cilastatin (Imipenem + Cilastatin)

Intravenously (intravenously) is drip.

The dosage form for intravenous use should not be given intramuscularly.

The recommendations for the dosage of the drug indicate the amount of imipenem to be administered.

Calculation of the total daily dose of the drug Imipenem + Cilastatin should be based on the severity of the infection and be divided into several applications in equal doses, taking into account the degree of sensitivity of one or more pathogenic microorganisms, renal function and body weight.

Dosing regimen for adult patients with normal renal function:

The dosages given in Table 1 are calculated for patients with normal renal function (creatinine clearance greater than 70 ml / min / 1.73 m²) and body weight ≥ 70 kg. In patients with creatinine clearance ≤ 70 ml / min / 1.73 m² (see Table 2) and / or a body weight of less than 70 kg (see Table 3), a reduction in the dose of the drug is necessary. It is especially important to reduce the dose depending on body weight in those patients whose weight is well below 70 kg and / or there is moderate or severe renal failure.

The average therapeutic daily dose is 1-2 g imipenem, divided into 3-4 applications (see Table 1). For treatment of moderate infections, the drug can also be applied at a dose of 1 g twice daily.

In the case of infections caused by less sensitive microorganisms, the daily dose of the drug for intravenous infusions can be increased to a maximum of 4 g (imipenem) per day or 50 mg / kg per day, whichever dose is lower. Each dose of the drug Imipenem + Cilastatin for intravenous infusions, less than or equal to 500 mg, should be administered intravenously within 20-30 minutes. Each dose of more than 500 mg should be administered intravenously for 40-60 minutes. Patients who experience nausea during infusion should slow the rate of injection.

Table 1. Dosage regimen of Imipenem + Cilastatin for intravenous infusion in adults with normal renal function and body weight ≥70 kg *

* Patients with a body weight of less than 70 kg need a further proportional reduction in doses administered.

Due to the high antimicrobial activity of the drug, it is recommended that its total daily dose not exceed 50 mg / kg or 4 g (imipenem) / day, whichever dose is lower.Although patients with cystic fibrosis with normal renal function were treated with the drug at a dose of up to 90 mg / kg per day, divided into several applications, the total dose did not exceed 4 g (imipenem) per day.

The drug was successfully used in monotherapy in cancer patients with weakened immunity in the case of confirmed or suspected infections, for example, sepsis.

Dosage regimen for adult patients with impaired renal function:

To correct the dose of the drug in the treatment of adult patients with impaired renal function, it is necessary:

- Based on the characteristics of the infection, choose from Table 1 the total daily dose of the drug.

- From Table 2, select the appropriate reduced dose of the drug, based on the daily dose (Table 1) and the creatinine clearance of this patient. (To calculate the infusion time, see the "Dosage Scheme for Adult Patients with Normal Kidney Function" section).

- From Table 3, choose in the left column the value of the body weight closest to the patient's body weight (kg).

Table 2. Dosage regimen of Imipenem + Cilastatin for intravenous infusion in adults with impaired renal function and body weight >70 kg *

* Patients with a body weight of less than 70 kg need a further proportional reduction in the administered doses.

Table 3. Dosage regimen of Imipenem + Cilastatin for intravenous infusions for adults with impaired renal function and / or body weight less than 70 kg

The maximum daily dose of 1.0 g

The maximum daily dose of 1.5 g

The maximum daily dose of 2.0 g

The maximum daily dose of 3.0 g

The maximum daily dose of 4.0 g

When a dose of 500 mg is administered to patients with a creatinine clearance of 6-20 ml / min / 1.73 m² may increase the risk of seizures.

The drug should not be administered intravenously to patients with a creatinine clearance less than 5 ml / min / 1.73 m² with the exception of cases when hemodialysis will be performed no later than 48 hours after the infusion of the drug.

Hemodialysis

When treating patients with creatinine clearance less than 5 ml / min / 1.73 m², on hemodialysis, recommendations should be applied on the dosage regimen for patients with creatinine clearance of 6-20 ml / min / 1.73 m² (see subsection "Dosage regimen for adult patients with impaired renal function").

Both imipenem and cilastatin are excreted during hemodialysis from the circulatory system. In this regard, the drug should be administered to patients after hemodialysis and then at 12-hour intervals from the end of the procedure.

Patients on hemodialysis, especially if they have central nervous system diseases, should be carefully monitored; administration of the preparation Imipenem + Cilastatin to patients undergoing hemodialysis is recommended only in cases when the benefit of treatment exceeds the potential risk of seizures (see the section "With caution").

At present, there is insufficient data to recommend the drug to patients on peritoneal dialysis.

The state of the kidney in elderly patients can not be fully determined only on the basis of measuring the level of residual blood nitrogen or creatinine. To determine the dosage of such patients, it is recommended to determine the clearance of creatinine.

Elderly patients

For elderly patients with normal renal function, dose adjustment is not required.

Impaired liver function

For patients with impaired liver function, dose adjustment is not required.

Prevention: dosing regimen for adult patients

For the prevention of postoperative infections in adults, the drug should be administered at a dose of 1 g with anesthesia and then 1 g after 3 hours. In the case of surgical intervention with a high degree of risk (for example, in operations on the thick and rectum), two additional doses of 500 mg should be administered at 8 and 16 hours after the initial anesthesia.

Dosage regimen for children from 3 months of age

The following dosing regimen is recommended for children:

- Children with a body weight of ≥40 kg should receive the same doses as adult patients.

- Children older than 3 months with a body weight of less than 40 kg should receive the drug at a dose of 15 mg / kg at 6-hour intervals. The maximum daily dose should not exceed 2 g.

The drug Imipenem + Cilastatin is not recommended for the treatment of meningitis. If suspected of having meningitis, appropriate antibiotics should be prescribed.

Rules for the preparation of solution

The drug Imipenem + Cilastatin for intravenous infusion can not be mixed or added to other antibiotics.

Drug Form of the preparation Imipenem + Cilastatin for intravenous infusions has a chemical incompatibility with lactic acid (lactate) and should not be prepared on the basis of solvents containing lactate. However, intravenously, the drug can be administered via the same infusion system as the lactate-containing solution.

The following solvents are used to prepare the infusion solution: 0.9% sodium chloride solution, 5% dextrose solution, 10% dextrose solution, 5% dextrose solution and 0.9% sodium chloride solution, 5% dextrose solution and 0.45% sodium chloride solution, 5% dextrose solution and 0.225% sodium chloride solution, 5% dextrose solution and 0.15% potassium chloride solution, 5% and a 10% solution of mannitol in a ratio of 500 mg of imipenem to 100 ml of the solvent. The concentration of imipenem in the resulting solution is 5 mg / ml.

Vials with a capacity of 20 ml or 30 ml

When using a vial with a preparation with a capacity of 20 ml or 30 ml, 10 ml of a suitable solvent must be added to the contents of the vial. The vial is shaken well to obtain a uniform suspension.

The resulting suspension can not be used for administration!

The resulting suspension is transferred to a vial or container with the rest of the solvent (90 ml). The total volume of the solvent is 100 ml. For the complete transfer of the drug (residues on the walls of the vial): 10 ml of the previously obtained solution are added to a 20 ml or 30 ml vial, shaken well, then the two solutions are combined. Thoroughly mix the resulting solution until it becomes clear. Only after this, the solution is ready for use. Differences in the color of the solution from colorless to yellow do not affect the activity of the preparation. The concentration of imipenem in the resulting solution is 5 mg / ml.

Vials with a capacity of 100 ml

When using the drug in vials of 100 ml capacity, the contents of the vial are dissolved in 100 ml of a suitable solvent. The concentration of imipenem in the resulting solution is 5 mg / ml.