Pharmacokinetics of Didanosine and Drug Resistance Mutations in Infants Exposed to Zidovudine During Gestation or Postnatally and Treated With Didanosine or Zidovudine in the First Three Months of Life

Kovács, Andrea; Cowles, Mary Kathryn; Britto, Paula; Capparelli, Edmund V.; Fowler, Mary Glenn; Moye, John; McIntosh, Ken; Rathore, Mobeen H.; Pitt, Jane; Husson, Robert N.

doi:10.1097/01.inf.0000164787.63237.0b

Cited by 5 publications

(1 citation statement)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[34] Current US and European guidelines, [14] do not have dosing recommendations for abacavir for infants <3 months of age. For didanosine, higher AUC values have been reported with the currently recommended pediatric dose of didanosine in younger infants (<4 months of age), [35] and European and US guidelines currently recommend a 2-fold range of dosing for this agent. Data on tenofovir disoproxil fumarate dosing in younger children are limited and the dosing guidelines for this agent in children younger than 12 years of age are based on investigational doses.…”

Section: Nucleoside Nucleotide Reverse Transcriptase Inhibitors (Nrtis)mentioning

confidence: 89%

Antiretroviral Drugs in Pediatric HIV-Infected Patients

Phelps

Rakhmanina

2011

Pediatric Drugs

View full text Add to dashboard Cite

Antiretroviral (ARV) therapy has been shown to achieve high therapeutic efficacy in treating pediatric HIV disease. The delivery of affordable, child friendly, and easy to store and administer ARV drugs is key to the successful management of HIV in children. In recent years, significant progress has been made in scaling up the access to pediatric ARV therapy among children worldwide. Despite the improved ARV drug access, multiple challenges remain concerning palatability and efficient delivery of ARV drugs to children from infancy into adolescence. Data are limited regarding developmental changes in pharmacokinetics of individual ARV drugs, and pediatric and adult fixed-dose combinations. This review provides a practical discussion regarding the pharmacokinetics of ARV agents in pediatric HIV-infected patients, as well as the practical challenges of currently available formulations, such as palatability of liquid formulations, challenges of crushing tablets, and using adult and pediatric fixed-dose combinations.

show abstract

Section: Nucleoside Nucleotide Reverse Transcriptase Inhibitors (Nrtis)mentioning

confidence: 89%

Antiretroviral Drugs in Pediatric HIV-Infected Patients

Phelps

Rakhmanina

2011

Pediatric Drugs

View full text Add to dashboard Cite

show abstract

Drug Labeling and Exposure in Neonates

et al. 2014

View full text Add to dashboard Cite

Importance Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, approximately 50% of drug labels still have insufficient information on safety, efficacy, or dosing in children. Neonatal information in labeling is even scarcer because neonates comprise a vulnerable subpopulation for which end point development is lagging and studies are more challenging. Objective To quantify progress made in neonatal studies and neonatal information in product labeling as result of recent legislation. Design 1. Cohort of neonatal drug studies; and 2. Cohort of infants exposed to these drugs.. Setting 1. Neonatal drug studies: FDA website; 2. National review: infants admitted to a neonatal intensive care unit (NICU) Participants 1) We identified drug studies between 1997 and 2010 that included neonates as a result of pediatric legislation using information available on the FDA website. We determined what studies were published in the medical literature, the legislation responsible for the studies, and the resulting neonatal labeling changes. 2) We then examined the use of these drugs in neonates admitted to 290 NICUs (the Pediatrix Data Warehouse) in the United States from 2005–2010. Exposures Infants exposed to a drug studied in neonates as identified by the FDA website Main outcome measures Number of drug studies with neonates and rate of exposure per 1000 admission among infants admitted to a NICU Results In a review of the FDA databases, we identified 28 drugs studied in neonates and 24 related labeling changes. Forty-one studies encompassed the 28 drugs, and 31 (76%) of these were published. Eleven (46%) of the 24 neonatal labeling changes established safety and effectiveness. In a review of a cohort of 446,335 hospitalized infants, we identified 399 drugs used and 1,525,739 drug exposures in the first 28 postnatal days. Thirteen (46%) of the 28 drugs studied in neonates were not used in NICUs; 8 (29%) were used in fewer than 60 neonates. Of the drugs studied, ranitidine was used most often (15,627 neonates, 35 exposures per 1000 admissions). Conclusions and Relevance Few drug labeling changes made under pediatric legislation include neonates. Most drugs studied are either not used or rarely used in U.S. NICUs. Strategies to increase the study of safe and effective drugs for neonates are needed.

show abstract

Didanosine

2007

Neonatal Formulary

View full text Add to dashboard Cite

Pharmacokinetics of Didanosine and Drug Resistance Mutations in Infants Exposed to Zidovudine During Gestation or Postnatally and Treated With Didanosine or Zidovudine in the First Three Months of Life

Cited by 5 publications

References 24 publications

Antiretroviral Drugs in Pediatric HIV-Infected Patients

Antiretroviral Drugs in Pediatric HIV-Infected Patients

Drug Labeling and Exposure in Neonates

Didanosine

Contact Info

Product

Resources

About