In late May 2015, the U.S. Food and Drug Administration (FDA) approved the use of antibacterial meropenem in infants and children under 3 months of age with complicated intra-abdominal infections.

Previously, meropenem was approved for the treatment of complicated intra-abdominal infections and complicated infections of the skin and soft tissues in adult patients and older children, however, the appointment of meropenem to premature babies with intra infections -abdominal severity was "off label" (the use of this indication in premature infants and children in the first 3 months of life was absent in the drug instructions), however, an effective alternative antibacterial drug to be used according to this indication in this category of missing comrade patients.

In response to a written request from the FDA to review the rational regimen and safety of meropenem in complicated intraabdominal infections in children within the first 3 months of life, the National Institutes of Health (NIH) has launched a study on the use of meropenem in children under 3 months of age. including premature babies. FDA approval is based on the results of a prospective open-label multicenter study evaluating numerous pharmacokinetic points and safety parameters in which 200 children participated (average age 21 days, average gestational age at birth - 27.8 weeks).

Based on the results of the study, meropenem was found to be a well tolerated and safe antibacterial drug in a cohort of children in the first 3 months of life in critical condition with serious and potentially infected infections. threatening. The use of meropenem did not increase the risk of serious side effects. The most common adverse events with meropenem were sepsis (6%), seizures (5%), increased levels of conjugated bilirubin (5%) and hypokalemia (5%). Only 2 of the serious adverse events were considered to be associated with the use of meropenem.

The efficacy of the treatment was evaluated in 96% of the patients and amounted to 84.4% (95% confidence interval 78.5-89.2%).

Thus, this study demonstrated that meropenem is an effective and safe antibacterial drug for use in the smallest patients with complicated intra-abdominal infections.

In the near future, the instructions for meropenem will be changed by the FDA, including recommendations for dosing the drug in newborns and children up to 3 months of age with complicated intra-abdominal infections.