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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:  05/08/2008
 
Trade Name:  Desmopressin acetate Tablets, 0.1 mg and 0.2 mg
 
Generic Name or Proper Name (*):  desmopressin acetate
 
Indications Studied:  Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE)
 
Label Changes Summary:  Efficacy in RCCT was evaluated in a single trial with children 3 to 18 years old Three studies evaluated efficacy in children 5 to 17 years old with PNE; an additional study evaluated efficacy in adolescents 12 to 17 years old Fluid intake should be adjusted downward in children to decrease the potential occurrence of water intoxication and hyponatremia Dosing information provided for children 3 to 18 years old for RCCT Dosing information provided for pediatric patients 6 years of age and older with PNE Tablet dosage and administration information provided for children with central diabetes insipidus Pharmacokinetics and pharmacodynamics were evaluated in children New indications and dosing regimen
 
PREA(P):  P
 
Sponsor:  Ferring
 
NNPS:  FALSE'
 
Therapeutic Category:  Urology
 
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