Doxycycline, clindamycin, caffeine citrate get updated pediatric labels
Changes to the pediatric drug labels for doxycycline, clindamycin and caffeine citrate mean they now include better information for health care providers on recommended usage and dosage, the NIH said.
The changes were a result of research funded by the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
“Doctors routinely make off-label drug decisions when treating infants and children because many drugs do not have pediatric safety or dosage recommendations,” Perdita Taylor-Zapata, MD, who heads the Best Pharmaceuticals for Children Act (BPCA) program at the NICHD, said in a statement. “The BPCA program supports research to improve the information on labels so that health care providers have clear guidance on how to prescribe drugs for their youngest patients.”
The revision to the drug label for doxycycline, which is used to treat life-threatening infectious diseases such as Rocky Mountain spotted fever and anthrax, includes weight-based dosing recommendations for IV and oral formulations to treat serious diseases that have no alternative therapies in children aged 2 to 8 years.
The revised drug label for clindamycin, which can treat lower respiratory tract, intra-abdominal and other infections, updates weight-based dosing information for oral and IV forms of the drug.
Caffeine citrate, which is prescribed to treat apnea of prematurity, is commonly used off-label for infants born earlier than 28 weeks of pregnancy, although the previous label offered guidance only for infants born between 28 and 32 weeks of pregnancy. The revised label indicates that the drug may safely be given to preterm infants born earlier than 28 weeks of pregnancy. The dose and duration may be higher and longer than what the previous label recommended, the NIH said.
The full label changes for each drug can be viewed at this link.
Reference:
NIH. NIH-funded research leads to pediatric labeling updates for doxycycline, clindamycin and caffeine citrate. https://www.nih.gov/news-events/news-releases/nih-funded-research-leads-pediatric-labeling-updates-doxycycline-clindamycin-caffeine-citrate. Accessed April 6, 2020.