The antibiotic meropenem was approved ~ the agency of the U. S. Food and Drug Administration during treating abdominal infections in children smaller quantity than 3 months of age. The approval came subsequently a study by a National Institutes of Health research network evaluated the drug in treating children in this date group.
The May 28 issue of The Federal Register described the study which supported the approval of meropenem in spite of “complicated intra-abdominal infections” in children in a state of inferiority to 3 months of age. Among preterm infants, intestinal perforation or leakage — which is side of complicated intra-abdominal infection — may have existence life threatening. The study was undertaken subordinate to the terms of the Best Pharmaceuticals notwithstanding Children Act, which directed NIH to manner of life studies on drugs used in children excepting not previously tested in children or in especial pediatric age groups.
Meropenem is a indecent spectrum antibiotic — effective against a vast variety of bacteria. The drug has been beforehand approved to treat complicated intra-ventral infections and complicated skin infections in adults and older children, and concerning treating children 3 months of epoch and older with bacterial meningitis — one infection of the fluid bathing the brain and spinal cord. During the last several years, physicians be under the necessity begun prescribing meropenem for preterm infants with serious abdominal infections. Because they lacked an effective alternative, many physicians had prescribed the physic for a use other than that which the FDA had approved. The NIH study was undertaken in response to a written request from the FDA to evaluate the dosing and preservation of meropenem in the treatment of complicated intra-ventral infections in infants under 3 months of date.
“This study shows that meropenem is appropriate in quest of treating complicated intra-abdominal infections in very young infants. In addition, we a little while ago have dosing guidelines for various time groups of premature infants,” said Anne Zajicek, M.D., Pharm.D., master of the Obstetric and Pediatric Pharmacology and Therapeutics Branch at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which funded the study.
Dr. Zajicek explained that physicians ofttimes need to extrapolate from studies of adults at the time prescribing for pediatric patients, because frequent drugs have never been tested specifically on this account that use in children. However, because of their smaller glutinous substance, differences in metabolism, and other natural differences from adults, many drugs may overcome children differently than they do adults. Under the Best Pharmaceuticals because of Children Act, NICHD works with FDA to make identical drugs not tested in children to give direction to if they are appropriate for conversion to an act in children.
The NICHD commissioned the study to search out meropenem use in 200 infants in a state of inferiority to 3 months of age, including precocious infants. Researchers examined how the drug was absorbed and distributed throughout the visible form, and used that information to disclose dosing recommendations for different age groups of infants, including hasty infants of different ages. In joining, the study evaluated side effects. Based in c~tinuance this study, treatment of infants through meropenem was safe and was not associated by increased risk for serious side goods.
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