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Search results for calcitriol in Note (approximate match)
Showing 1 - 3 of 3 results
Status:
US Approved Rx
(2017)
Source:
ANDA203897
(2017)
Source URL:
First approved in 1998
Source:
NDA020819
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Paricalcitol (Zemplar) is a synthetic vitamin D(2) analogue that inhibits the secretion of parathyroid hormone (PTH) through binding to the vitamin D receptor. It is approved in the US and in most European nations for intravenous use in the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure in adult, and in the US paediatric, patients. Paricalcitol effectively reduced elevated serum PTH levels and was generally well tolerated in children and adults with secondary hyperparathyroidism associated with chronic renal failure. In well designed clinical trials, paricalcitol was as effective as calcitriol and as well tolerated in terms of the incidence of prolonged hypercalcaemia and/or elevated calcium-phosphorus product (Ca x P). Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the vitamin D receptor, which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.
Status:
Other
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
1β-CALCITRIOL is an Impurity B of Calcitriol. Calcitriol(1,25-Dihydroxyvitamin D3; Rocaltrol ) is the hormonally active form of vitamin D, Calcitriol is the active metabolite of vitamin D3 that activates the vitamin D receptor (VDR). 1-epicalcitriol is a potent antagonist of 1,25(OH)2D3-induced intestinal calcium
transport (transcaltachia).
Status:
US Approved Rx
(2008)
Source:
ANDA078066
(2008)
Source URL:
First approved in 1978
Source:
NDA018044
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Trans-calcitriol or Calcitriol Impurity A, is the impurity of Calcitriol. Calcitriol is the hormonally active form of vitamin D, Calcitriol is the active metabolite of vitamin D3 that activates the vitamin D receptor (VDR). Calcitriol Impurity A is the physiologically active form of vitamin D. It is formed primarily in the kidney by enzymatic hydroxylation of 25-hydroxycholecalciferol (CALCIFEDIOL). Its production is stimulated by low blood calcium levels and parathyroid hormone. Calcitriol increases intestinal absorption of calcium and phosphorus, and in concert with parathyroid hormone increases bone resorption.