Food and Drug Administration Update for Pediatric Practitioners

Marcia L. Buck, Pharm.D., FCCP


Pediatr Pharm. 2002;8(1) 

In This Article

New Dosing Information

At the end of the year, the FDA approved a request by Pfizer to include information on one-day and three-day dosing regimens for acute otitis media in their product labeling for Zithromax®. Although the FDA's Anti-Infective Drugs Advisory Committee recommended approval for these shorter regimens during their November 7th meeting, committee members stated their concern over the lack of pharmacokinetic data in children supporting the one-day regimen. The manufacturer did supply data in adults, as well as data in children comparing three- and five-day regimens.[8]

Lamivudine (Epivir-HBV®; GlaxoSmithKline) is known to be effective in reducing the symptoms of chronic hepatitis B infection. On August 16, 2001, the FDA approved the addition of dosing information for this use in children to the product labeling. The recommended dose for children 2 to 17 years of age is 3 mg/kg/day, given once daily, not to exceed 100 mg.[9]

On August 28, 2001, pharmacokinetic information in pediatric patients was added to the labeling information for sufentanil (Sufenta®; Akorn). The elimination half-life of sufentanil in infants and children has been found to be significantly shorter than that of adolescents and adults (97±42 versus 434±160 minutes, respectively). Conversely, the clearance in neonates is approximately half that in older patients, making a reduction in dose necessary. Neonates with cardiovascular disease appear to have an even slower clearance, requiring further dosage adjustment.[10]


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