Sinerpen (cilastatin, imipenem) powder for solution for infusion 30 ml. vial

Description

Sinerpen (cilastatin, imipenem) powder for solution for infusion 30 ml. vial

Composition

active substances: imipenem and cilastatin sodium;

1 vial contains imipenem (sterile) 530.10 mg equivalent to anhydrous imipenem 500 mg; cilastatin sodium salt (sterile) 530.70 mg equivalent to cilastatin 500 mg;

Excipient: sodium bicarbonate.

Dosage form

Powder for solution for infusion.

Main physical and chemical properties: white or pale yellow powder.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Imipenem and enzyme inhibitor.
ATX code J01D H51.

Pharmacological properties

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.

Indications

Sinerpen 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.

Contraindications

Sinerpen 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

Sinerpen 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.

Overdose

Not described.

Side effects:

• 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.