Dosing Recommendations for Pediatric Patients With Renal Impairment
| Autor: | Caitlyn Young, Jian Wang, Mona Khurana, Daijha J.C. Anderson, Shiew-Mei Huang, Gilbert J. Burckart, Amer Al-khouja, Kyunghun Park |
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| Rok vydání: | 2020 |
| Předmět: |
Drug
medicine.medical_specialty Prescription Drugs Special populations Databases Factual media_common.quotation_subject Formularies as Topic urologic and male genital diseases Pediatrics 030226 pharmacology & pharmacy Article Clinical study 03 medical and health sciences 0302 clinical medicine Humans Medicine Drug Dosage Calculations Pharmacology (medical) Renal Insufficiency Dosing Child Intensive care medicine Drug toxicity Drug Labeling media_common Pharmacology Evidence-Based Medicine United States Food and Drug Administration business.industry United States Drug development Clinical evidence 030220 oncology & carcinogenesis Drug Information Services Practice Guidelines as Topic business Clearance |
| Zdroj: | J Clin Pharmacol |
| ISSN: | 1552-4604 0091-2700 |
| DOI: | 10.1002/jcph.1676 |
| Popis: | A treatment gap exists for pediatric patients with renal impairment. Alterations in renal clearance and metabolism of drugs render standard dosage regimens inappropriate and may lead to drug toxicity, but these studies are not routinely conducted during drug development. The objective of this study was to examine the clinical evidence behind current renal impairment dosage recommendations for pediatric patients in a standard pediatric dosing handbook. The sources of recommendations and comparisons included the pediatric dosing handbook (Lexicomp), the U.S. Food and Drug Administration-approved manufacturer’s labels, and published studies in the literature. One hundred twenty-six drugs in Lexicomp had pediatric renal dosing recommendations. Only 14% (18 of 126) of Lexicomp pediatric renal dosing recommendations referenced a pediatric clinical study, and 15% of manufacturer’s labels (19 of 126) described specific dosing regimens for renally impaired pediatric patients. Forty-two products had published information on pediatric renal dosing, but 19 (45%) were case studies. When pediatric clinical studies were not referenced in Lexicomp, the renal dosing recommendations followed the adult and pediatric dosing recommendations on the manufacturer’s label. Clinical evidence in pediatric patients does not exist for most renal dosing recommendations in a widely used pediatric dosing handbook, and the adult renal dosing recommendations from the manufacturer’s label are currently the primary source of pediatric renal dosing information. |
| Databáze: | OpenAIRE |
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