Exipenem (meropenem) powder for solution for infusion 1000 mg. vial №1

Description

Exipenem Storage
active substance: meropenem;

each vial contains meropenem trihydrate in an amount corresponding to meropenem

1000 mg;

Excipient: sodium carbonate anhydrous.

Exipenem Dosage form
Powder for solution for injection.

Basic physical and chemical properties: powder from white to light yellow color.

Exipenem Pharmacotherapeutic group
Antimicrobials for systemic use. Other β-lactam antibiotics. Carbapenems. Meropenem.

ATX code J01DH02.

Pharmacological properties

Pharmacodynamics.

Meropenem has a bactericidal effect by inhibiting the synthesis of bacterial cell walls in gram-positive and gram-negative bacteria by binding to penicillin-binding blood proteins (PBPs).

As with other beta-lactam antibacterial agents, time scores at which meropenem concentrations exceeded minimum inhibitory concentrations (MICs) (T> MICs) indicated a high degree of correlation with efficacy. In preclinical models, meropenem showed activity at plasma concentrations exceeding the MIC for infectious microorganisms by approximately 40% of the dosing interval. This target has not been established clinically.

Bacterial resistance to meropenem can occur as a result of: (1) – decreased permeability of the outer membrane of gram-negative bacteria (due to reduced porin production), (2) – decreased affinity for target PBP, (3) – increased expression of efflux pump components and (4) – production of beta-lactamases that can hydrolyze carbapenems.

Outbreaks of carbapenem-resistant bacteria have been reported in the European Union.

There is no cross-resistance between meropenem and drugs belonging to the classes of quinolones, aminoglycosides, macrolides and tetracyclines, taking into account the target microorganisms. However, bacteria may be resistant to more than one class of antibacterial drugs when the mechanism involved involves the impermeability of the cell membrane and / or the presence of efflux pump (s).

Indication
Exipenem is indicated for the treatment of such infections in adults and children over 3 months of age:

pneumonia, including community-acquired and nosocomial pneumonia;
bronchopulmonary infections in cystic fibrosis;
complicated urinary tract infections;
complicated intra-abdominal infections;
infections during childbirth and postpartum infections;
complicated skin and soft tissue infections;
acute bacterial meningitis.
Exipenem can be used to treat patients with neutropenia and fever if a bacterial infection is suspected.

Treatment of patients with bacteremia that is or may be associated with any of the above infections.

Official recommendations for the appropriate use of antibacterial drugs should be followed.

Contraindication
Hypersensitivity to the active substance or to any of the excipients.

Hypersensitivity to any other antibacterial agent of the carbapenem group.

Severe hypersensitivity (eg anaphylactic reactions, severe skin reactions) to any other type of beta-lactam antibacterial agent (eg penicillins or cephalosporins).