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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  12/20/2019
Trade Name:  Vibramycin, Vibra-Tabs
Generic Name or Proper Name (*):  doxycycline monohydrate; doxycycline hyclate; doxycycline calcium; doxycycline hyclate
Indications Studied:  Postmarketing study
Label Changes Summary:  *Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 pediatric patients 2-18 years showed that allometrically -scaled clearance (CL) of doxycycline in pediatric patients =2 to =8 years of age did not differ significantly from pediatric patients >8 to 18 years. *For pediatric patients weighing =45 kg, body weight normalized doxycycline CL in those =2 to =8 years did not differ significantly from those >8 to 18 years. * In pediatric patients weighing >45 kg, no clinically significant differences in body weight normalized doxycycline CL were observed between those =2 to =8 years and those >8 to 18 years of age. *No clinically significant difference in CL between oral and IV dosing was observed in the small cohort of pediatric patients who received the oral (N=19) or IV (N=2l) formulation alone. *Off-patent Written Request.
Sponsor:  Pfizer, Inc.
Therapeutic Category:  Antibiotic