Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
11/16/2001
Trade Name:
Calcijex
Generic Name or Proper Name (*):
calcitriol
Indications Studied:
Management of hypocalcemia in patients undergoing chronic renal dialysis
Label Changes Summary:
The safety and effectiveness of calcitriol was examined in a double-blind placebo-controlled trial of 35 pediatric patients (13-18 years of age) with end-stage renal disease and on dialysis. The primary efficacy endpoint favored the calcitriol-treated versus the placebo-treated patients Transient hypercalcemia was seen in 1 of 16 calcitriol-treated patients; 6 of 16 (38%) calcitriol-treated patients and 2 of 19 (11%) placebo-treated patients had Ca x P >75
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Abbott
Pediatric Exclusivity Granted Date:
02/16/2001
NNPS:
FALSE'
Therapeutic Category:
Vitamin
-
-