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New Pediatric Labeling Information Database - Detail
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Pediatrics
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.
BPCA(B):
B
Sponsor:
Pfizer, Inc.
NNPS:
FALSE
Therapeutic Category:
Antibiotic
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