Imipenem / Cilastatin Kabi (Imipenem / Cilastatin Kabi)

DOSAGE FORM FOR INTRAVENOUS APPLICATION SHOULD NOT BE INTRODUCED INSIDE.

In the recommendations for dosing of the preparation Imipenem / Cilastatin Cubi, the amount of imipenem to be administered is indicated.

Calculation of the total daily dose of the preparation Imipenem / Cilastatin Cubi 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 Imipenem / Cilastatin Cubi for intravenous infusion, less than or equal to 500 mg, should be given intravenously for 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 the preparation Imipenem / Cilastatin Cubi for intravenous infusions 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 preparation Imipenem / Cilastatin Cubi, 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 was treated with Imipenem / Cilastatin Cabi in 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 preparation Imipenem / Cilastatin Cubi 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 "Dosing Scheme for Adult Patients with Normal Kidney Function" section).

- from Table 3, choose in the left column the body weight nearest to the patient's body weight (kg).

Table 2. Dosage regimen of the preparation Imipenem / Cilastatin Cubi for intravenous infusions in adult patients 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 doses administered.

Table 3. Dosage regimen of Imipenem / Cilastatin Cubi 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 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 / 1.73² possibly increasing the risk of developing seizures.

The preparation Imipenem / Cilastatin Cubi should not be administered intravenously to patients with 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 Imipenem / Cilastatin Cubi.

Hemodialysis

When treating patients with creatinine clearance less than 5 ml / min / 1.73 m², on hemodialysis, recommendations should be applied for the dosing regimen of the preparation Imipenem / Cilastatin Cubi for patients with creatinine clearance 6-20 ml / min / 1.73 m² (see the section "Treatment: Dosage Scheme for Adult Patients with Impaired Renal Function").

Both imipenem and cilastatin are excreted during hemodialysis from the circulatory system.In this regard, the preparation Imipenem / Cilastatin Cubi for intravenous infusion 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 Imipenem / Cilastatin Cubi to patients undergoing hemodialysis is recommended only in cases when the benefits of treatment exceed the potential risk of seizures (see the section "With caution").

Currently, there is insufficient data to recommend the preparation Imipenem / Cilastatin Cubi for intravenous administration 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 preparation Imipenem / Cilastatin Cubi for intravenous infusions should be administered at a dose of 1 g with anesthesia and then 1 g in 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 body weight ≥40 kg should receive the same dose 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 Kabi is not recommended for the treatment of meningitis. If suspected of having meningitis, appropriate antibiotics should be prescribed.

Preparation of a solution for intravenous infusion

Preparation Imipenem / Cilastatin Cubi for intravenous infusion is not possiblemix or add to other antibiotics and other medicines, except those listed below.

Drug form of the preparation Imipenem / Cilastatin Cubi for intravenous infusions is chemically incompatible with lactic acid (lactate) and should not be prepared on the basis of solvents containing lactate. However, the intravenous drug Imipenem / Cilastatin Cubi can be administered via the same infusion system as the lactate-containing solution.

Solution of the preparation Imipenem / Cilastatin Cubi for intravenous infusions is prepared according to the following Table 4. The final infusion solution must be shaken until a clear solution is obtained. The color of the solutions of the preparation Imipenem / Cilastatin Cubi varies from colorless to yellow (a change in color within these limits does not affect the activity of the drug).

Table 4. Preparation of a solution of the preparation Imipenem / Cilastatin Cubi for intravenous infusions

For a bottle of 20 ml

In the vial with the preparation Imipenem / Cilastatin Cubi, it is necessary to add 10 ml of the appropriate solvent from the list shown in Table 5. The resulting primary suspension should be thoroughly shaken and added to the infusion bottle containing 90 ml of the infusion solvent.

PRIMARY SUSPENSION CAN NOT BE USED FOR INTRODUCTION.

For the complete transfer of the drug, the procedure must be repeated by adding 10 ml of the previously obtained solution from the infusion bottle to the vial of powder residues. The resulting suspension should be thoroughly shaken and added to an infusion bottle containing 40 ml of an infusion solvent (for a dosage of 250 mg) or 90 ml (for a dosage of 500 mg)).

The total volume of the solvent is 50 ml (for a dosage of 250 mg) and 100 ml (for a dosage of 500 mg).

The final infusion solution must be shaken until a clear solution is obtained.

After the procedure described above, the concentration of both imipenem and cilastatin in the reconstituted solution is approximately 5 mg / ml.

Table 5 presents data on the timing of the use of the infusion solution of the preparation Imipenem / Cilastatin Cubi,prepared on the basis of a number of infusion solvents and stored at room temperature or in a refrigerator.

Table 5

Each bottle is for single use only.

The bottle with the medicinal product must be in the original carton before use.