Imipenem and Cilastatin Jodas 500 mg + 500 mg 20 ml No. 10 bottle
Content
Indications Contraindications With caution Use during pregnancy and breastfeeding Method of administration and dosage Elderly patients Impaired liver function For children, the following dosage regimen is recommended: Side effects Overdose Storage conditions Expiration date
Indications
The drug "Imipenem and Cilastatin Jodas" for intravenous administration is used in the treatment of severe infections caused by microorganisms sensitive to it, as well as for empirical treatment of the infectious process even before its bacterial pathogens are identified. The drug "Imipenem and Cilastatin Jodas" for intravenous administration is indicated for the treatment of:
- Lower respiratory tract infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase-producing strains), Acinetobacter spp., Enterobacter spp., Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp., Serratia marcescens;
- Urinary tract infections (complicated and uncomplicated) caused by Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Enterobacter spp., Escherichia coli, Klebsiella spp., Morganella morganii, Proteus vulgaris, Providencia rettgeri, Pseudomonas aeruginosa;
- Intra-abdominal infections caused by Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Citrobacter spp., Enterobacter spp., Escherichia coli, Klebsiella spp., Morganella morganii, Proteus spp., Pseudomonas aeruginosa, Bifidobacterium spp., Clostridium spp. ., Eubacterium spp., Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp., Bacteroides spp., including Bfragilis, Fusobacterium spp.;
- Gynecological infections caused by Enterococcus faecalis. Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Escherichia coli, Streptococcus agalactiae (group B streptococci), Enterobacter spp., Gardnerella vaginalis, Klebsiella spp., Proteus spp., Bifidobacterium spp., Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp., Bacteroides spp., including B.fragilis;
- Bacterial septicemia caused by Streptococcus pneumoniae, Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Enterobacter spp., Escherichia coli, Klebsiella spp., Serratia spp., Bacteroides spp., including B.fragilis, Pseudomonas aeruginosa;
- Infections of bones and joints caused by Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Enterobacter spp., Pseudomonas aeruginosa;
- Skin and soft tissue infections caused by Streptococcus pyogenes, Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Staphylococcus epidermidis, Acinetobacter spp., Citrobacter spp., Enterobacter spp., Escherichia coli, Klebsiella spp., Morganella morganii, Proteus vulgaris, Providencia rettgeri, Pseudomonas aeruginosa, Serratia spp., Peptococcus spp., Peptostreptococcus spp., Bacteroides spp., including B.fragilis, Fusobacterium spp.;
- Infectious endocarditis caused by Staphylococcus aureus (penicillinase-producing strains);
- To prevent postoperative infections in patients at risk with a high probability of developing a postoperative infectious complication, as well as in patients with a high risk of intraoperative infection during surgery.
Contraindications
Hypersensitivity to any of the components of the drug, other beta-lactam antibiotics, penicillins and cephalosporins.
- Children under 3 months.
- Children with impaired renal function (serum creatinine more than 2 mg/dl).
- Patients with creatinine clearance less than 5 ml/min/1.73 m2.
Carefully
Pseudomembranous colitis.
- Patients with a history of gastrointestinal diseases.
- Patients with creatinine clearance <70 ml/min/1.73 m2.
- Patients on hemodialysis.
- Patients with diseases of the central nervous system.
Use during pregnancy and breastfeeding
No studies have been conducted in pregnant women. The drug should be used during pregnancy only if the benefit to the mother justifies the potential risk to the fetus.
Imipenem is found in human breast milk. If the use of the drug is considered necessary, then breastfeeding should be stopped.
Directions for use and doses
THE DOSAGE FORM FOR INTRAVENOUS USE SHOULD NOT BE ADMINISTERED INTRAMUSCULARLY.
The calculation of the total daily dose of Imipenem and Cilastatin Jodas 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, renal function and body weight.
The average therapeutic daily dose is 1-2 g of imipenem, divided into 3-4 applications. For the treatment of moderate infections, the drug can also be used at a dose of 1g 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 Imipenem and Cilastatin Jodas 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.
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
For the prevention of postoperative infections in adults, the drug "Imipenem and Cilastatin Jodas" 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.
The drug "Imipenem and Cilastatin Jodas" is not recommended for the treatment of meningitis. If meningitis is suspected, appropriate antibiotics should be prescribed.
Preparation of solution for intravenous infusion
The drug "Imipenem and Cilastatin Jodas" for intravenous infusion cannot be mixed or added to other antibiotics.
The dosage form of the drug "Imipenem and Cilastatin Jodas" for intravenous infusion is chemically incompatible with lactic acid (lactate) and should not be prepared on the basis of solvents containing lactate. However, the intravenous drug "Imipenem and Cilastatin Jodas" can be administered through the same infusion system as the solution containing lactate.
The solution of the drug "Imipenem and Cilastatin Jodas" 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 solutions of the drug "Imipenem and Cilastatin Jodas" varies from colorless to yellow (color changes within these limits do not affect the activity of the drug).
For 20 ml bottle
In the bottle with the drug "Imipenem and Cilastatin Jodas" you must first add 10 ml of the appropriate solvent from the list presented in Table 5. 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.
Side effects
- Infectious and parasitic diseases: pseudomembranous colitis, candidiasis, gastroenteritis.
- From the blood and lymphatic system: eosinophilia, pancytopenia, neutropenia, leukopenia, thrombocytopenia, thrombocytosis, agranulocytosis, hemolytic anemia, inhibition of the red line of the bone marrow.
- From the immune system: anaphylactic reactions.
- From the psyche: mental disorders, including hallucinations and states of confusion.
- From the nervous system: convulsions, myoclonus, dizziness, drowsiness, encephalopathy, paresthesia, tremor, taste perversion, exacerbation of myasthenia gravis, headache, agitation, dyskinesia.
- From the organ of hearing and labyrinthine disorders: hearing loss, vertigo, ringing in the ears.
- Cardiac disorders: cyanosis, tachycardia, palpitations.
- Vascular disorders: thrombophlebitis, decreased blood pressure, hot flashes.
- From the respiratory system, chest and mediastinal organs: shortness of breath, hyperventilation, sore throat.
- From the gastrointestinal tract: diarrhea, vomiting, nausea, staining of teeth and/or tongue, hemorrhagic colitis, abdominal pain, heartburn, glossitis, hypertrophy of the tongue papillae, hypersalivation.
- From the liver and biliary tract: liver failure, hepatitis, fulminant hepatitis.
- From the skin and subcutaneous tissues: rash (including exanthematous), urticaria, itching, toxic epidermal necrolysis, angioedema, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, hyperhidrosis, changes in skin structure.
- Musculoskeletal and connective tissue disorders: polyarthralgia, pain in the thoracic spine.
- From the kidneys and urinary tract: acute renal failure, oliguria/anuria, polyuria, change in urine color (safe and should not be mistaken for hematuria). The role of Imipenem and Cilastatin Jodas in changes in renal function is difficult to assess because other factors predisposing to prerenal azotemia or deterioration of renal function are usually present.
- From the genital organs and breast: genital itching.
- General disorders and disorders at the injection site: fever, pain and induration at the injection site, erythema at the injection site, chest discomfort, asthenia/weakness.
- Laboratory indicators: increased activity of serum transaminases, increased activity of alkaline phosphatase, positive direct Coombs test, increased prothrombin time, decreased hemoglobin, increased serum bilirubin concentration, increased serum creatinine concentration, increased blood urea nitrogen concentration.
Overdose
Symptoms of overdose are consistent with the adverse reaction profile and may include convulsions, confusion, tremor, nausea, vomiting, decreased blood pressure, and bradycardia. There is no specific information on the treatment of overdose of Imipenem and Cilastatin Jodas. Imipenem - cilastatin sodium is eliminated during hemodialysis, but the effectiveness of this procedure in case of drug overdose is unknown.
Storage conditions
Store at a temperature not exceeding 30°C.
Keep out of the reach of children.
Best before date
3 years.
Imipenem+Cilastatin
Intravenous (IV) drip. The dosage form for intravenous administration should not be administered intramuscularly.
Calculation of the total daily dose of the drug should be based on the severity of the infection and distributed over several administrations in equal doses, taking into account the degree of sensitivity of one or more pathogenic microorganisms, renal 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 (CC) more than 70 ml/min/1.73 m2) and body weight ≥ 70 kg.
In patients with CC <70 ml/min/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 administrations (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 the drug less than or equal to 500 mg should be administered as an intravenous infusion 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. Dosing regimen for intravenous infusion in adult patients with normal renal function and body weight ≥ 70 kg
| Severity of infection | Imipenem dose | Break between infusions | Total daily dose |
| light | 250 mg | 6 hours | 1 g |
| average | 500 mg | 8 hours | 1.5 g |
| 1000 mg | 12h | 2 g | |
| severe (sensitive pathogens) | 500 mg | 6 hours | 2 g |
| severe and/or life-threatening, caused by less sensitive microorganisms (primarily certain strains P. aeruginosa ) | 1000 mg | 8 hours | 3.0 g |
| 1000 mg | 6 hours | 4.0 g |
In patients weighing less than 70 kg, a further proportional reduction in administered doses is necessary.
The maximum daily dose is 4 g or 50 mg/kg, whichever is lower.
There is evidence that in patients with cystic fibrosis over 12 years of age with normal renal function, the drug was administered at a dose of up to 90 mg/kg per day, divided into several doses, with the total dose not exceeding 4 g per day.
Imipenem + Cilastatin has been successfully used 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 indicated in Table 1 and clearance (CC) in a given patient;
- from Table 3, select the patient’s body weight (kg) in the left column.
The infusion time is calculated according to the dosing regimen for adult patients with normal renal function.
Table 2. Dosage regimen for adults with impaired renal function and body weight ≥ 70 kg*
| Total daily dose of imipenem (from Table 1) | CC (ml/min/1.73 m2) | ||
| 41-70 | 21-40 | 6-20 | |
| 1 g | 250 mg every 8 hours | 250 mg every 12 hours | 250 mg every 12 hours |
| 1.5 g | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 12 hours |
| 2 g | 500 mg every 8 hours | 250 mg every 6 hours | 250 mg every 12 hours |
| 3 g | 500 mg every 6 hours | 500 mg every 8 hours | 500 mg every 12 hours |
| 4 g | 750 mg every 8 hours | 500 mg every 6 hours | 500 mg every 12 hours |
* In patients weighing less than 70 kg, a further proportional reduction in administered doses is necessary.
Table 3. Dosage regimen for adult patients with impaired renal function and/or body weight less than 70 kg
Maximum daily dose 1.0 g
| Body weight, kg | Creatinine clearance, ml/min/1.73 m2 | |||
| ≥71 | 41-70 | 21-40 | 6-20 | |
| ≥70 | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 12 hours | 250 mg every 12 hours |
| 60-69 | 250 mg every 8 hours | 125 mg every 6 hours | 250 mg every 12 hours | 125 mg every 12 hours |
| 50-59 | 125 mg every 6 hours | 125 mg every 6 hours | 125 mg every 8 hours | 125 mg every 12 hours |
| 40-49 | 125 mg every 6 hours | 125 mg every 8 hours | 125 mg every 12 hours | 125 mg every 12 hours |
| 30-39 | 125 mg every 8 hours | 125 mg every 8 hours | 125 mg every 12 hours | 125 mg every 12 hours |
Maximum daily dose 1.5 g
| Body weight, kg | Creatinine clearance, ml/min/1.73 m2 | |||
| ≥71 | 41-70 | 21-40 | 6-20 | |
| ≥70 | 500 mg every 8 hours | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 12 hours |
| 60-69 | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 8 hours | 250 mg every 12 hours |
| 50-59 | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 12 hours | 250 mg every 12 hours |
| 40-49 | 250 mg every 8 hours | 125 mg every 6 hours | 125 mg every 8 hours | 125 mg every 12 hours |
| 30-39 | 125 mg every 6 hours | 125 mg every 8 hours | 125 mg every 8 hours | 125 mg every 12 hours |
Maximum daily dose 2.0 g
| Body weight, kg | Creatinine clearance, ml/min/1.73 m2 | |||
| ≥71 | 41-70 | 21-40 | 6-20 | |
| ≥70 | 500 mg every 6 hours | 500 mg every 8 hours | 250 mg every 6 hours | 250 mg every 12 hours |
| 60-69 | 500 mg every 8 hours | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 12 hours |
| 50-59 | 250 mg every 6 hours | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 12 hours |
| 40-49 | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 12 hours | 250 mg every 12 hours |
| 30-39 | 250 mg every 8 hours | 125 mg every 6 hours | 125 mg every 8 hours | 125 mg every 12 hours |
Maximum daily dose 3.0 g
| Body weight, kg | Creatinine clearance, ml/min/1.73 m2 | |||
| ≥71 | 41-70 | 21-40 | 6-20 | |
| ≥70 | 1000 mg every 8 hours | 500 mg every 6 hours | 500 mg every 8 hours | 500 mg every 12 hours |
| 60-69 | 750 mg every 8 hours | 500 mg every 8 hours | 500 mg every 8 hours | 500 mg every 12 hours |
| 50-59 | 500 mg every 6 hours | 500 mg every 8 hours | 250 mg every 6 hours | 250 mg every 12 hours |
| 40-49 | 500 mg every 8 hours | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 12 hours |
| 30-39 | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 8 hours | 250 mg every 12 hours |
Maximum daily dose 4.0 g
| Body weight, kg | Creatinine clearance, ml/min/1.73 m2 | |||
| ≥71 | 41-70 | 21-40 | 6-20 | |
| ≥70 | 1000 mg every 6 hours | 750 mg every 8 hours | 500 mg every 6 hours | 500 mg every 12 hours |
| 60-69 | 1000 mg every 8 hours | 750 mg every 8 hours | 500 mg every 8 hours | 500 mg every 12 hours |
| 50-59 | 750 mg every 8 hours | 500 mg every 6 hours | 500 mg every 8 hours | 500 mg every 12 hours |
| 40-49 | 500 mg every 6 hours | 500 mg every 8 hours | 250 mg every 6 hours | 250 mg every 12 hours |
| 30-39 | 500 mg every 8 hours | 250 mg every 6 hours | 250 mg every 8 hours | 250 mg every 12 hours |
When administering a dose of 500 mg to patients with CC 6-20 ml/min/1.73 m2, the risk of seizures may increase.
The drug Imipenem + Cilastatin should not be administered intravenously to patients with CC less than 5 ml / min / 1.73 m2, unless hemodialysis will be performed no later than 48 hours after the infusion of the drug Imipenem + Cilastatin.
Hemodialysis
For patients with CC less than 5 ml/min/1.73 m2 who are on hemodialysis, the drug should be administered in doses recommended for patients with CC 6-20 ml/min/1.73 m2, immediately after the hemodialysis session and after 12 hours intervals from the moment the procedure is completed.
Patients undergoing hemodialysis, especially those with central nervous system disease, should be closely monitored.
The use of the drug in patients on hemodialysis is recommended only in cases where the benefit of treatment outweighs the potential risk of developing seizures. Currently, there is insufficient data to recommend the use of the drug in patients undergoing peritoneal dialysis.
Elderly patients
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. 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
For the prevention of postoperative infections - 1000 mg during induction of anesthesia and 1000 mg after 3 hours. In case of surgery with a high risk of infection (surgery on the colon and rectum), an additional 500 mg is administered 8 hours and 16 hours after induction anesthesia
Dosing in children from 3 months of age
For children over 3 months of age and weighing up to 40 kg, the single dose is 15 mg/kg, administered every 6 hours. The maximum daily dose is 2 g.
Children weighing 40 kg or more are prescribed the same doses as adult patients. Imipenem + Cilastatin is not recommended for the treatment of meningitis. If meningitis is suspected, appropriate antibiotics should be prescribed.
Preparation of solution for infusion and administration
Imipenem + Cilastatin should not be mixed or added to other antibiotics. The drug is chemically incompatible with lactic acid (lactate) and its solutions should not be prepared using solvents containing lactate. However, Imipenem + Cilastatin can be administered intravenously through the same infusion system as the lactate-containing solution.
The solution for infusion is prepared in two stages:
1) for initial dissolution, add 10 ml of a suitable solvent to the bottle with antibiotic powder. Shake the bottle well to obtain a homogeneous suspension. The suspension cannot be used for administration!
2) the resulting suspension is transferred using a syringe into a bottle with the rest of the solvent (90 ml). The total volume of solvent is 100 ml.
In order to completely transfer the contents of the bottle (including the remains of the drug on the walls of the bottle), add 10 ml of the previously obtained solution to the bottle, shake well, then combine both solutions. The concentration of imipenem in the finished solution for infusion is 5 mg/ml. Differences in the color of the solution from colorless to yellow do not affect the activity of the drug.
Administered intravenously. The duration of the infusion depends on the chosen dose: 250-500 mg is administered over 20-30 minutes; over 500 mg - within 40-60 minutes. If nausea occurs during administration, the rate of administration of the drug is reduced.
Solutions of the drug for infusion (imipenem concentration 5 mg/ml), prepared using solvents: 0.9% sodium chloride solution, 5% and 10% dextrose solutions, 5% dextrose solution with 0.9% sodium chloride, 5% dextrose solution with 0.45% sodium chloride, 5% dextrose solution with 0.225% sodium chloride, 5% dextrose solution with 0.15% potassium chloride, 5% and 10% mannitol solution can be stored for 4 hours at room temperature (25 ° C ) or for 24 hours in the refrigerator (4 °C).
