DESCRIPTION
ROCALTROL ® BRAND OF CALCITRIOL
CAPSULES and ORAL
SOLUTION
Rocaltrol (calcitriol) is a synthetic
vitamin D analog
which is active in the regulation
of the absorption
of calcium from the
gastrointestinal tract and its utilization in the body. Rocaltrol
is available as capsules containing 0.25 mcg
or 0. 5 mcg calcitriol
and as an oral solution
containing 1 mcg/mL of calcitriol. All dosage
forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene
(BHT) as antioxidants. The capsules contain a fractionated triglyceride
of coconut oil, and the oral
solution contains a fractionated triglyceride of palm
seed oil. Gelatin capsule
shells contain glycerin, parabens (methyl and propyl) and sorbitol,
with the following dye systems:
0.25 mcg FD&C Yellow
No. 6 and titanium dioxide; 0.5 FD&C Red No. 3, FD&C Yellow
No. 6 and titanium
dioxide. The oral solution
contains no additional adjuvants
or coloring principles.
Calcitriol is a white, crystalline
compound which occurs
naturally in humans. It has a calculated molecular weight
of 416.65 and is soluble
in organic solvents but relatively insoluble
in water. Chemically, calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1a,3
b ,25-triol.
The other names frequently used for calcitriol
are 1a ,25-dihydroxycholecalciferol,
1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3
and 1,25-diOHC.
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