Treatment in adults and children from 1 year of age of infections caused by susceptible microorganisms: intraperitoneal infections; lower respiratory tract infections (severe pneumonia, including hospital and ventilator-associated pneumonia); intranasal and postpartum infections; complicated infections of the genitourinary system; complicated infections of the skin and soft tissues; infections of bones and joints; septicemia; endocarditis. SINERPEN can be used in the treatment of patients with neutropenia accompanied by a fever, a likely cause of which is a bacterial infection. Treatment of patients with bacteraemia associated with or likely to be associated with any of the above infections.
Composition and form of release
Active ingredient: cilastatin (500 mg / vial), imipenem (500 mg / vial).
Synerpen is produced in the form of a powder for the preparation of a solution for injection.
This is a combined antibacterial agent. Imipenem is a beta-lactam antibiotic carbapenem. It inhibits the synthesis of bacterial cell walls, exhibits a bactericidal effect.
Cilastatin is a specific enzyme that inhibits the metabolism of imipenem in the kidneys, while increasing the concentration of unchanged antibiotic in the urinary tract.
Synerpen is shown:
- with an infection of the lower respiratory tract;
- with skin infection;
- with genital infection;
- with septicemia;
- with urinary tract infection;
- with an infection of the abdominal organs;
- with infection of the bone, joints;
- with soft tissue infection;
- with infective endocarditis;
- with mixed infection (including Bacteroides fragilis);
- for the prevention of postoperative complications.
Synerpen should not be prescribed:
- with allergies to components;
- with meningitis.
Application during pregnancy and lactation
The safety of use has not been studied, therefore, the drug is prescribed only if necessary, taking into account the possible risks to the fetus.
When treating lactating women, feeding is stopped.
Method of administration and dosage
Synerpen is used parenterally.
The average daily dose depends on the severity of the infection, kidney condition, body weight and is divided into several doses.
Standard dose (for individuals 70 kg with normal renal function): intravenously 1-2 g / day (for imipenem) for 3-4 infusions. The maximum is 4000 mg or 50 mg / kg.
The standard dose for children weighing over 40 kg is as an adult; for children weighing less than 40 kg – 15 mg / kg at 6-hour intervals.
Preparation of the infusion solution: 100 ml of solvent must be added to the powder bottle with 500 mg of imipenem; 200 ml of solvent must be added to a bottle of powder with 1000 mg of imipenem.
As a solvent, you can use:
- 5% aqueous glucose solution;
- isotonic sodium chloride solution;
- 10% aqueous glucose solution;
- 5% glucose solution + 0.45% sodium chloride;
- 5% glucose solution + 0.9% sodium chloride;
- 5% glucose solution + 0.15% potassium chloride;
- 5% glucose solution + 0.225% sodium chloride;
- 5% or 10% mannitol solution.
The resulting solution (5 mg / ml) should be shaken until transparent.
Do not use solvents containing lactic acid salt.
- Digestive disorders: diarrhea, nausea, liver dysfunction, tooth staining, pseudomembranous colitis, hepatitis.
- Local reactions: pain, infiltrates at the injection site, erythema, thrombophlebitis.
- Allergic reactions: rash, itching, fever, urticaria, anaphylactic reactions, angioedema, erythema multiforme, Lyell’s syndrome, exfoliative dermatitis.
- Changes in laboratory data: eosinophilia, leukopenia, neutropenia, thrombocytopenia, thrombocytosis, anemia, positive direct Coombs’ test.
- Urinary disorders: increased levels of creatinine, urea nitrogen, anuria / oliguria, polyuria, acute kidney failure, discoloration of urine.
- Neurological disorders: myoclonus, paresthesias, confusion, hallucinations, epileptic seizures, impaired taste.
Storage conditions and periods
Synerpen should be stored for no more than 2 years at temperatures up to 25 ° C. After dilution, the solution can be stored for no more than 4 hours (at room temperature) or 24 hours (in the refrigerator).