Tienam 500 mg+500 mg N10 powder for solution

Directions for use and doses

IM and IV. IV, as an infusion: ≤500 mg - over 20-30 minutes, >500 mg - 40-60 minutes. The average daily dose is 2000 mg (4 injections). The maximum daily dose is 4000 mg (50 mg/kg). The dose is adjusted taking into account the severity of the condition, body weight and renal function of the patient.

For the prevention of postoperative infections in adults, IV - 1000 mg during induction of anesthesia and 1000 mg after 3 hours. With a very high risk of postoperative infection, another 500 mg IV 8 and 16 hours after anesthesia. Children, incl. body weight less than 40 kg and for sepsis - 15 mg/kg every 6 hours (but not more than 2000 mg/day).

IM, adults - 500 or 750 mg every 12 hours (up to 1500 mg/day).

Instructions for use TIENAM® (TIENAM)

Tienam® is administered intravenously as an infusion. The drug is not intended for intramuscular administration.

Recommended doses of Thienam® are based on imipenem.

The total daily dose of Thienam is calculated taking into account the severity of the infection, the degree of sensitivity of one or more pathogenic microorganisms, kidney function and body weight. The daily dose is divided into several infusions in equal doses.

For the purpose of treatment
in adults with normal renal function (creatinine clearance more than 70 ml/min/1.73 m2) and body weight ≥ 70 kg, the drug
is administered in the doses given in Table 1.

The average therapeutic daily dose is 1-2 g, divided into 3-4 administrations per day (Table 1). For the treatment of moderate infections, the drug can also be used at a dose of 1 g 2 times a day.

In the case of infections caused by less sensitive microorganisms, the daily dose of the drug for intravenous infusion can be increased to a maximum of 4 g/day or 50 mg/kg/day, whichever dose is lower.

Thienam® in a single dose of 500 mg or less should be administered intravenously as an infusion over 20-30 minutes. The drug in a single dose of more than 500 mg should be administered intravenously as an infusion over 40-60 minutes. If nausea occurs during the infusion, the rate of drug administration should be slowed down.

Table 1. Tienam dosage regimen for intravenous infusion in adults with normal renal function and body weight ≥ 70 kg

*In patients weighing less than 70 kg, a further proportional dose reduction is necessary.

Due to the high antibacterial activity of Tienam, it is recommended that its total daily dose should not exceed 50 mg/kg or 4 g/day. However, patients with cystic fibrosis with normal renal function received Tienam® at a dose of up to 90 mg/kg/day, divided into several doses, while the total dose did not exceed 4 g/day.

Thienam® has been successfully used as monotherapy in immunocompromised cancer patients with confirmed or suspected infections, such as sepsis.

Adults with impaired kidney function

In patients with CC ≤ 70 ml/min/1.73 m2

(Table 2)
and/or body weight less than 70 kg
(Table 3) requires a reduction in the dose of the drug. It is especially important to reduce the dose depending on body weight in those patients who weigh significantly less than 70 kg and/or have moderate or severe renal failure.

To adjust 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, select the total daily dose of the drug from Table 1;
• from Table 2, select the appropriate reduced dose of the drug based on the daily dose (Table 1) and QC for a given patient. The infusion time is calculated according to the dosing regimen for adult patients with normal renal function.

Table 2. Tienam dosage regimen for intravenous infusion in adults with impaired renal function and body weight ≥ 70 kg

*In patients weighing less than 70 kg, a further proportional dose reduction is necessary.

Table 3. Tienam dosage regimen for intravenous infusion in adults weighing less than 70 kg

Maximum daily dose 1 g

Maximum daily dose 1.5 g

Maximum daily dose 2 g

Maximum daily dose 3 g

Maximum daily dose 4 g

When administering the drug at a dose of 500 mg in patients with CC 6-20 ml/min/1.73 m2

the risk of developing seizures may increase.

Tienam® should not be used in patients with CC less than 5 ml/min/1.73 m2

except in cases where hemodialysis will be performed no later than 48 hours after Tienam infusion.

Hemodialysis.

When treating
patients with creatinine clearance less than 5 ml/min/1.73 m2 who are on hemodialysis
, recommendations for the Tienam dosage regimen should be used for patients with creatinine clearance 6-20 ml/min/1.73 m2 (as indicated above).

Both imipenem and cilastatin are eliminated from the circulatory system during hemodialysis. In this regard, Tienam® should be administered after hemodialysis and then at intervals of 12 hours from the completion of the procedure. Patients undergoing hemodialysis, especially those with central nervous system diseases, should be closely monitored. Prescription of Thienam to patients undergoing hemodialysis is recommended only in cases where the expected benefit of therapy outweighs the potential risk of developing seizures.

Currently, there is insufficient data to recommend Tienam® for the treatment of patients on peritoneal dialysis.

In elderly patients

The condition of the kidneys cannot be fully assessed solely on the basis of determining the level of residual blood nitrogen or creatinine. To select a dose in this category of patients, it is recommended to determine QC.

To prevent postoperative infections

Tienam® is administered
to adults
at a dose of 1 g during induction of anesthesia and then 1 g after 3 hours. In case of
high-risk surgery (for example, during operations on the colon and rectum),
2 additional doses of 500 mg should be administered after 8 and 16 hours after induction of anesthesia.

Children aged 3 months and older

Children weighing ≥ 40 kg

the drug is prescribed in the same doses as for adults.

Children over 3 months weighing < 40 kg

the drug should be prescribed at a dose of 15 mg/kg at intervals of 6 hours.

The maximum daily dose is 2 g.

Rules for preparing a solution for infusion

Thienam solution for infusion should not be mixed or added to other antibiotics.

The dosage form of Tienam for infusion is chemically incompatible with lactic acid (lactate), therefore solvents containing lactate are not used to prepare the infusion solution. However, Thienam solution for infusion can be administered through the same infusion system as the solution containing lactate.

Thienam solution for infusion is prepared in accordance with the recommendations presented in Table 4. The resulting solution must be shaken until a clear liquid forms. Variations in the color of the solution from yellow to colorless do not affect the activity of the drug.

Table 4. Preparation of Tienam solution for infusion.

The contents of a 20 ml bottle must first be dissolved in 10 ml of an appropriate solvent. The resulting solution cannot be used for administration. This solution is shaken well and then transferred to the vial or container with the rest of the solvent (90 ml). The total volume of solvent is 100 ml.

To completely dissolve the drug:

• add 10 ml of the previously obtained solution to a 20 ml bottle. The resulting solution is shaken well, then both resulting solutions are combined. Mix the resulting solution thoroughly. The total volume of solvent is 100 ml.

Table 5. Terms of use of Tienam solution for infusion, prepared on the basis of a number of infusion solutions and stored at room temperature or in the refrigerator.

Tienam

IV drip and IM. The doses given below are calculated for a body weight of 70 kg or more and CC of 70 ml/min/1.73 sq.m or more. For patients with CC less than 70 ml/min/1.73 sq.m and/or lower body weight, the dose of the drug should be proportionally reduced. The intravenous route of administration is preferable to use in the initial stages of treatment of bacterial sepsis, endocarditis and other severe and life-threatening infections, incl. lower respiratory tract infections caused by Pseudomonas aeruginosa, and in case of severe complications.

To prepare the infusion solution, add 100 ml of solvent (0.9% NaCl solution, 5% aqueous dextrose solution, 10% aqueous dextrose solution, 5% dextrose solution and 0.9% NaCl, etc.) to the bottle. The concentration of imipenem in the resulting solution is 5 mg/ml.

The average therapeutic dose of the drug for adults with intravenous administration is 1-2 g/day, divided into 3-4 administrations; the maximum daily dose is 4 g or 50 mg/kg, whichever is lower. For patients with a mild degree of infection - 250 mg 4 times a day, for a moderate degree - 500 mg 3 times a day or 1 g 2 times a day, for a severe degree - 500 mg 4 times a day, for an infection that threatens the patient's life - 1 g 3-4 times a day. Every 250-500 mg is administered intravenously over 20-30 minutes, and every 1 g over 40-60 minutes.

For the prevention of postoperative infections - 1 g during induction of anesthesia and 1 g after 3 hours. In the case of surgery with a high risk of infection (surgery on the colon and rectum), an additional 500 mg is administered 8 and 16 hours after general anesthesia .

Maximum daily doses of the drug for intravenous administration in patients with renal failure, depending on the severity of the infection and CC values ​​(ml/min/1.73 sq.m):

for mild infection and CC 41-70 ml/min - 250 mg every 8 hours, CC 21-40 ml/min - 250 mg every 12 hours, CC 6-20 ml/min - 250 mg every 12 hours;

for moderate infection and CC 41-70 ml/min - 250 mg every 6 hours, CC 21-40 ml/min - 250 mg every 8 hours, CC 6-20 ml/min - 250 mg every 12 hours;

in severe cases (highly sensitive strains) and CC 41-70 ml/min - 500 mg every 8 hours, CC 21-40 ml/min - 250 mg every 6 hours, CC 6-20 ml/min - 250 mg every 12 hours; in severe cases (moderately sensitive strains, including Pseudomonas aeruginosa) and CC 41-70 ml/min - 500 mg every 6 hours, CC 21-40 ml/min - 500 mg every 8 hours, CC 6- 20 ml/min - 500 mg every 12 hours; in case of severe life-threatening infection and CC 41-70 ml/min - 750 mg every 8 hours, CC 21-40 ml/min - 500 mg every 6 hours, CC 6-20 ml/min - 500 mg in 12 hours

Patients with CC less than 5 ml/min are prescribed only if hemodialysis is performed every 48 hours, followed by administration 12 hours later (from the moment the procedure is completed).

For the prevention of postoperative infections in adults - 1 g during induction of anesthesia and again after 3 hours; for high-risk surgical interventions (on the colon and rectum) - an additional 500 mg is administered 8 and 16 hours after the start of general anesthesia. Currently, there is insufficient data on the dosage regimen for preoperative prophylaxis in patients with CC less than 70 ml/min/1.73 sq.m.

Children weighing 40 kg or more - the same doses as adults; with body weight less than 40 kg - 15 mg/kg 4 times a day; the maximum daily dose is 2 g.

IM administration of the drug can be used as an alternative to the IV form of the drug for the treatment of infections for which IM administration is preferable. Depending on the severity of the infection, the sensitivity of pathogenic microorganisms and the patient’s condition, 500-750 mg is administered every 12 hours. The total daily dose is no more than 1500 mg. If there is a need for large doses of the drug, it is necessary to use intravenous administration.

IM administration in patients with CC less than 20 ml/min/1.73 sq.m, as well as in children, has not been studied.

For the treatment of urethritis and cervicitis caused by Neisseria gonorrhoeae, 500 mg is administered once, intramuscularly. The powder is mixed with 2 ml of a 1% solution of lidocaine hydrochloride (without epinephrine), water for injection or 0.9% NaCl solution until a homogeneous suspension (white or slightly yellow) is formed.

Tienam®

THE DOSAGE FORM FOR INTRAVENOUS USE SHOULD NOT BE ADMINISTERED INTRAMUSCULARLY.

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

The calculation of the total daily dose of Thienam® should be based on the severity of the infection and distributed over several applications in equal doses, taking into account the degree of sensitivity of one or more pathogenic microorganisms, kidney function and body weight.

Dosage schedule for adult patients with normal renal function

The doses given in Table 1 are calculated for patients with normal renal function (creatinine clearance more than 70 ml/min/1.73 m2) and body weight ≥70 kg. In patients with creatinine clearance ≤70 ml/mi/1.73 m2 (see Table 2) and/or body weight less than 70 kg (see Table 3), a dose reduction is necessary. It is especially important to reduce the dose depending on body weight in those patients who weigh significantly less than 70 kg and/or have moderate or severe renal impairment.

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

In the case of infections caused by less sensitive microorganisms, the daily dose of the drug for intravenous infusion 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 Thienam® for intravenous infusion, less than or equal to 500 mg, should be administered intravenously over 20-30 minutes. Each dose over 500 mg should be administered intravenously over 40-60 minutes. Patients who experience nausea during the infusion should slow down the rate of drug administration.

Table 1. Dosage regimen of Tienam® for intravenous infusion in adult patients with normal renal function and body weight ≥70 kg*

*In patients weighing less than 70 kg, a further proportional reduction in administered doses is necessary.

Due to the high antimicrobial activity of Tienam®, it is recommended that its total daily dose should not exceed 50 mg/kg or 4 g (imipenem)/day, whichever is lower. Although patients with cystic fibrosis with normal renal function were treated with Tienam® 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. Thienam® has been successfully used as monotherapy in immunocompromised cancer patients with confirmed or suspected infections, such as sepsis.

Dosage schedule for adult patients with impaired renal function

To adjust 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, select the total daily dose of the drug from Table 1;

-from Table 2, select the appropriate reduced dose of the drug based on the daily dose (Table 1) and creatinine clearance of the patient (to calculate the infusion time, see the section “Dosage regimen for adult patients with normal renal function”);

-from Table 3, select in the left column the body weight value closest to the patient’s body weight (kg).

Table 2. Dosage regimen of Tienam® for intravenous infusion in adult patients with impaired renal function and body weight ≥70 kg*

* In patients weighing less than 70 kg, a further proportional reduction in administered doses is necessary.

Table 3. Dosage regimen of Tienam® for intravenous infusion in adult patients with impaired renal function and/or body weight less than 70 kg

Maximum daily dose 1.0 g

Maximum daily dose 1.5 g

Maximum daily dose 2.0 g

Maximum daily dose 3.0 g

Maximum daily dose 4.0 g

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

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

Hemodialysis

When treating patients with a creatinine clearance of less than 5 ml/min/1.73 m2 who are on hemodialysis, the recommendations for the dosage regimen of Tienam® for patients with a creatinine clearance of 6-20 ml/min/1.73 m2 should be applied (see section "Treatment: Dosing schedule for adult patients with impaired renal function").

Both imipenem and cilastatin are eliminated from the circulatory system during hemodialysis. In this regard, the drug Tienam® for intravenous infusion should be administered to patients after hemodialysis and then at 12-hour intervals from the completion of the procedure. Patients undergoing hemodialysis, especially those with diseases of the central nervous system, should be closely monitored; Prescribing Tienam® to patients undergoing hemodialysis is recommended only in cases where the benefit of treatment outweighs the potential risk of developing seizures (see section “With caution”).

Currently, there is insufficient data to recommend Tienam® for intravenous administration to patients on peritoneal dialysis.

Kidney health in elderly patients cannot be fully determined by measuring residual blood nitrogen or creatinine levels alone. To select dosages for such patients, it is recommended to determine creatinine clearance.

Elderly patients

For elderly patients with normal renal function, no dose adjustment is required.

Liver dysfunction

For patients with impaired liver function, no dose adjustment is required.

Prevention: dosage regimen for adult patients

To prevent postoperative infections in adults, Tienam® for intravenous infusion should be administered at a dose of 1 g during induction of anesthesia and then 1 g after 3 hours. For high-risk surgery (eg, colon and rectal surgery), two additional doses of 500 mg should be administered 8 and 16 hours after induction of anesthesia.

Dosage schedule for children from 3 months of age

For children, the following dosage regimen is recommended:

-Children weighing ≥40 kg should receive the same doses as adult patients.

-children over 3 months old and weighing 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.

Thienam® is not recommended for the treatment of meningitis. If meningitis is suspected, appropriate antibiotics should be prescribed.

Preparation of solution for intravenous infusion

Tienam® for intravenous infusion should not be mixed or added to other antibiotics.

The dosage form of Tienam® for intravenous infusion is chemically incompatible with lactic acid (lactate) and should not be prepared from solvents containing lactate. However, Thienam® can be administered intravenously through the same infusion system as the solution containing lactate.

A solution of Thienam® for intravenous infusion is prepared in accordance with Table 4 below. The final infusion solution must be shaken until a clear solution is obtained. The color of Tienam® solutions varies from colorless to yellow (color changes within these limits do not affect the activity of the drug).

Table 4. Preparation of Tienam® solution for intravenous infusion

For 20 ml bottle

You must first add 10 ml of the appropriate solvent from the list presented in Table 5 to the vial with Tienam®. The resulting primary suspension must be thoroughly shaken and added to an infusion bottle containing 90 ml of infusion solvent.

PRIMARY SUSPENSION SHOULD NOT BE USED FOR ADMINISTRATION.

To completely transfer the drug, the procedure must be repeated by adding 10 ml of the previously obtained solution from the infusion bottle to the bottle with the remaining powder. The resulting suspension must be shaken thoroughly and added to an infusion bottle containing 90 ml of infusion solvent.

The total volume of solvent is 100 ml.

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

Table 5 presents data on the period of use of the Tienam® infusion solution prepared on the basis of a number of infusion solvents and stored at room temperature or in the refrigerator.

Table 5.

Tienam 500 mg+500 mg N10 powder for solution

Latin name

Tienam

Release form

Powder for preparing a solution for intravenous administration.

Package

10 pieces.

pharmachologic effect

Tienam has antimicrobial, antibacterial, bactericidal effects. Imipenem inhibits the synthesis of bacterial cell walls, cilastatin inhibits the biotransformation of imipenem in the kidneys and increases its concentration in the urinary tract.

Indications

Intraperitoneal infections, infections of the lower respiratory tract, genitourinary system, bones and joints, skin and soft tissues; septicemia; endocarditis; prevention of postoperative infections; mixed infections.

Contraindications

Hypersensitivity (including to other beta-lactams - penicillins, cephalosporins), children's age (up to 3 months).

Use during pregnancy and breastfeeding

During pregnancy, it is prescribed exclusively for health reasons. When prescribed to nursing mothers, breastfeeding should be suspended.

special instructions

Do not administer in the same syringe with other antibiotics. Do not use solutions containing lactate as a solvent.

Compound

1 bottle contains imipenem 500 mg and cilastatin sodium 500 mg.

Directions for use and doses

Tienam is administered intramuscularly and intravenously. IV, as an infusion: ≤500 mg - over 20-30 minutes, >500 mg - 40-60 minutes. The average daily dose is 2000 mg (4 injections). The maximum daily dose is 4000 mg (50 mg/kg). The dose is adjusted taking into account the severity of the condition, body weight and renal function of the patient.

For the prevention of postoperative infections in adults, IV - 1000 mg during induction of anesthesia and 1000 mg after 3 hours. With a very high risk of postoperative infection, another 500 mg IV 8 and 16 hours after anesthesia. Children, incl. body weight less than 40 kg and for sepsis - 15 mg/kg every 6 hours (but not more than 2000 mg/day).

IM, adults - 500 or 750 mg every 12 hours (up to 1500 mg/day).

Side effects

Dyspepsia, changes in the quantitative content of blood cells, increased activity of liver enzymes; oliguria, anuria, polyuria, acute renal failure; epileptic seizures, myoclonus, mental disorders and confusion; taste disturbance, local reactions (erythema, pain and infiltration at the injection site, thrombophlebitis), pseudomembranous colitis, allergic reactions (itching, urticaria, fever, anaphylactic shock, etc.).

Drug interactions

Pharmaceutically incompatible with other antibiotics. In the presence of lactic acid it is inactivated.

Storage conditions

At a temperature of 25 °C.

Best before date

2 years.

Conditions for dispensing from pharmacies

On prescription

Thienam (portable prepared solution for inf. 500 mg + 500 mg vial 20 ml No. 10)

Active substance

Imipenem + Cilastatin

Compound

Bottle 20 ml Imipenem sterile 500 mg, cilastatin sodium sterile 500 mg. Excipients: sterile sodium bicarbonate - 20 mg. Powder for the preparation of solution for infusion from white to light yellow.

pharmachologic effect

Broad-spectrum beta-lactam antibiotic. Suppresses the synthesis of bacterial cell walls and has a bactericidal effect against a wide range of gram-positive and gram-negative microorganisms, aerobic and anaerobic. Imipenem is a derivative of thienamycin and belongs to the group of carbapenems. Cilastatin sodium inhibits dehydropeptidase, an enzyme that metabolizes imipenem in the kidneys, which significantly increases the concentration of unchanged imipenem in the urinary tract. Cilastin does not have its own antibacterial activity and does not inhibit bacterial beta-lactamase. Active against Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus faecalis and Bacteroides fragilis. Resistant to destruction by bacterial beta-lactamase, which makes it effective against many microorganisms, such as Pseudomonas aeruginosa, Serratia spp. and Enterobacter spp., which are resistant to most beta-lactam antibiotics. The antibacterial spectrum includes almost all clinically significant pathogenic microorganisms. Active against gram-negative aerobic bacteria: - Achromobacter spp., Acinetobacter spp. (formerly Mima - Herellea), Aeromonas hydrophila, Alcaligenes spp., Bordetella bronchicanis, Bordetella bronchiseptica, Bordetella pertussis, Brucella melitensis, Campylobacter spp., Capnocytophaga spp., Citrobacter spp. (including Citrobacter diversus, Citrobacter freundii), Eikenella corrodens, Enterobacter spp. (including Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (including strains that produce beta-lactamase), Haemophilus parainfluenzae, Hafnia alvei, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella ozaenae, Klebsiella pneumoniae), Moraxella spp., Morganella morganii (formerly Proteus morganii), Neisseria gonorrhoeae (including penicillinase-producing strains), Neisseria meningitidis, Yersinia spp. (formerly Pasteurella), incl. Yersinia multocida, Yersinia enterocolitica, Yersinia pseudotuberculosis; — Plesiomonas shigelloides, Proteus spp. (including Proteus mirabilis, Proteus vulgaris), Providencia spp. (including Providencia alcalifaciens, Providencia rettgeri (formerly Proteus rettgeri), Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas pseudomallei, Pseudomonas putida, Pseudomonas stutzeri), Salmonella spp. (including Salmonella typhi), Serratia spp. (including Serratia marcescens, Serratia proteamaculans), Shigella spp.; - gram -positive aerobic bacteria: Bacillus spp., Enterococcus faecalis, Erysipelothrix Rhusiopathiae, Listeria Monocardia spp., Pediococcus spp., Staphylococcus aureus (including Penicillinase strains), staphylococcus epidermidis (including strains forming penicillinase), staphylococcus saprophyticus, streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus group C, Streptococcus group G, viridans streptococci including alpha and gamma hemolytic strains); — gram-negative anaerobic bacteria: Bacteroides spp. (including Bacteroides distasonis, Bacteroides fragilis, Prevotella melaninogenica (formerly Bacteroides melaninogenicus), Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus), Bilophila wadsworthia, Fusobacterium spp., incl. (Fusobacterium necrophorum, Fusobacterium nucleatum), Porphyromonas asaccharolytica (formerly Bacteroides asaccharolyticus), Prevotella bivia (formerly Bacteroides bivius), Prevotella disiens (formerly Bacteroides disiens), Prevotella intermedia (formerly Bacteroides intermedius), Veillonella spp.; — gram-positive anaerobic bacteria: Actinomyces spp., Bifidobacterium spp., Clostridium spp. (including Clostridium perfringens), Eubacter spp., Lactobacillus spp., Microaerophilic streptococcus, Mobiluncus spp., Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp. (including Propionibacterium acne); — other microorganisms: Mycobacterium fortuitum, Mycobacterium smegmatis. Some Staphylococcus spp. (methicillin-resistant), Streptococcus spp. (group D), Stenotrophomonas maltophilia, Enterococcus faecium and some strains of Pseudomonas cepacia are not susceptible to imipenem. Effective against many infections caused by bacteria resistant to cephalosporins, aminoglycosides, and penicillins. In vitro, it acts synergistically with aminoglycosides against some strains of Pseudomonas aeruginosa.

Indications for use

- intra-abdominal infections; - lower respiratory tract infections; - infections of the genitourinary system; - infections of bones and joints; - infections of the skin and soft tissues; - infections of the pelvic organs; - sepsis; - bacterial endocarditis; — prevention of postoperative infections; - mixed infections; - nosocomial infections.

Mode of application

IV drip and IM. The doses given below are calculated for a body weight of 70 kg or more and CC = 70 ml/min/1.73 m2 or more. For patients with KKV/in the route of administration, it is preferable to use it in the initial stages of treatment of bacterial sepsis, endocarditis and other severe and life-threatening infections, incl. lower respiratory tract infections caused by Pseudomonas aeruginosa, and in case of severe complications. To prepare the infusion solution, add 100 ml of solvent (0.9% sodium chloride solution, 5% aqueous dextrose solution, 10% aqueous dextrose solution, 5% dextrose solution and 0.9% sodium chloride) to the bottle. The concentration of imipenem in the resulting solution is 5 mg/ml. The average therapeutic dose for adults with intravenous administration is 1-2 g/day, divided into 3-4 administrations; the maximum daily dose is 4 g or 50 mg/kg, whichever is lower. For patients with a mild degree of infection - 250 mg 4 times a day, a moderate degree - 500 mg 3 times a day or 1 g 2 times a day, a severe degree - 500 mg 4 times a day, for an infection that threatens the patient's life - 1 g 3-4 times/day. Every 250-500 mg is administered intravenously over 20-30 minutes, and every 1 g over 40-60 minutes. For the prevention of postoperative infections - 1 g during induction of anesthesia and 1 g after 3 hours. In the case of surgery with a high risk of infection (surgery on the colon and rectum), an additional 500 mg is administered 8 and 16 hours after general anesthesia . Maximum daily doses for intravenous administration in patients with renal failure, depending on the severity of the infection and CC values ​​(ml/min/1.73 m2): - for mild infection and CC 41-70 ml/min - 250 mg every 8 h, CC 21-40 ml/min - 250 mg every 12 hours, CC 6-20 ml/min - 250 mg every 12 hours; - for moderate infection and CC 41-70 ml/min - 250 mg every 6 hours, CC 21-40 ml/min - 250 mg every 8 hours, CC 6-20 ml/min - 250 mg every 12 hours ; - in severe cases (highly sensitive strains) and CC 41-70 ml/min - 500 mg every 8 hours, CC 21-40 ml/min - 250 mg every 6 hours, CC 6-20 ml/min - 250 mg after 12 hours; - in severe cases (moderately sensitive strains, including Pseudomonas aeruginosa) and CC 41-70 ml/min - 500 mg every 6 hours, CC 21-40 ml/min - 500 mg every 8 hours, CC 6 -20 ml/min - 500 mg every 12 hours; - in case of severe life-threatening infection and CC 41-70 ml/min - 750 mg every 8 hours, CC 21-40 ml/min - 500 mg every 6 hours, CC 6-20 ml/min - 500 mg every 12 hours. Patients with CC less than 5 ml/min are prescribed only if hemodialysis is performed every 48 hours, followed by administration 12 hours later (from the moment the procedure is completed). For the prevention of postoperative infections in adults - 1 g during induction of anesthesia and again after 3 hours; for high-risk surgical interventions (on the colon and rectum) - an additional 500 mg is administered 8 and 16 hours after the start of general anesthesia. Currently, there is insufficient data on the dosage regimen for preoperative prophylaxis in patients with CC less than 70 ml/min/1.73 m2. Children weighing 40 kg or more - the same doses as adults; with body weight less than 40 kg - 15 mg/kg 4 times a day; the maximum daily dose is 2 g. IM administration can be used as an alternative to the IV form of the drug for the treatment of infections for which IM administration is preferable. Depending on the severity of the infection, the sensitivity of pathogenic microorganisms and the patient’s condition, 500-750 mg is administered every 12 hours. The total daily dose is no more than 1500 mg. If there is a need for large doses of the drug, it is necessary to use intravenous administration. IM administration in patients with CC less than 20 ml/min/1.73 m2, as well as in children, has not been studied. For the treatment of urethritis and cervicitis caused by Neisseria gonorrhoeae, 500 mg is administered once, intramuscularly. The powder is mixed with 2 ml of a 1% solution of lidocaine hydrochloride (without epinephrine), water or 0.9% sodium chloride solution until a homogeneous suspension (white or slightly yellow) is formed.

Interaction

Pharmaceutically incompatible with lactic acid salt and other antibacterial drugs. When used simultaneously with penicillins and cephalosporins, cross-allergy is possible; exhibits antagonism towards other beta-lactam antibiotics (penicillins, cephalosporins and monobactams). Ganciclovir increases the risk of developing generalized seizures. Drugs that block tubular secretion slightly increase the plasma concentration and T1/2 of imipenem (if high concentrations of imipenem are required, the use of these drugs at the same time is not recommended).

Side effect

From the central nervous system and peripheral nervous system: myoclonus, mental disorders, hallucinations, confusion, epileptic seizures, paresthesia. From the urinary system: oliguria, anuria, polyuria, acute renal failure (rare). From the digestive system: nausea, vomiting, diarrhea, pseudomembranous enterocolitis, hepatitis (rare). From the hematopoietic organs and hemostasis system: eosinophilia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, thrombocytosis, monocytosis, lymphocytosis, basophilia, decreased hemoglobin, prolonged prothrombin time, positive Coombs test. From the laboratory parameters: - increased activity of liver transaminases and alkaline phosphatase, hyperbilirubinemia, hypercreatininemia, increased concentration of urea nitrogen; - direct positive Coombs test. Allergic reactions: skin rash, itching, urticaria, exudative erythema multiforme (including Stevens-Johnson syndrome), angioedema, toxic epidermal necrolysis (rare), exfoliative dermatitis (rare), fever, anaphylactic reactions. Local reactions: skin hyperemia, painful infiltration at the injection site, thrombophlebitis. Other: candidiasis, taste disturbance.

Contraindications

- hypersensitivity (including to carbapenems and other beta-lactam antibiotics);
— pregnancy (only for “vital” indications); — early childhood (up to 3 months); in children - severe renal failure (serum creatinine concentration more than 2 mg/dl). For a suspension for intramuscular injection prepared using lidocaine hydrochloride as a solvent: - hypersensitivity to local anesthetics of amide structure (shock, intracardiac conduction disturbance). With caution: central nervous system diseases, lactation period, old age. Use during pregnancy and breastfeeding Contraindication: pregnancy (use is possible only for health reasons). With caution: lactation period.

special instructions

Not recommended for the treatment of meningitis. Colors urine reddish. The dosage form for intramuscular administration should not be used for intravenous administration and vice versa. Before initiating therapy, a thorough medical history should be obtained regarding previous allergic reactions to beta-lactam antibiotics. Individuals with a history of gastrointestinal diseases (especially colitis) have an increased risk of developing pseudomembranous enterocolitis. Therapy with antiepileptic drugs in patients with a history of traumatic brain injury or seizures should continue throughout the entire period of treatment with the drug (to avoid side effects from the central nervous system). It should be kept in mind that elderly patients are likely to have age-related renal impairment, which may require dose reduction.

Storage conditions

Room temperature

Dispensing conditions in pharmacies

On prescription