CALCITRIOL- calcitriol 0.25 mcg capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

CALCITRIOL (UNII: FXC9231JVH) (CALCITRIOL - UNII:FXC9231JVH)

Disponible des:

Atlantic Biologicals Corps

Designació comuna internacional (DCI):

CALCITRIOL

Composición:

CALCITRIOL 0.25 ug

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Calcitriol capsule is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Calcitriol capsule is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Calcitriol capsule is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseu

Resumen del producto:

Product: 17856-0723 NDC: 17856-0723-1 1 CAPSULE in a DOSE PACK

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CALCITRIOL- CALCITRIOL 0.25 MCG CAPSULE
ATLANTIC BIOLOGICALS CORPS
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CALCITRIOL CAPSULES (0.25 MCG & 0.5 MCG)
RX ONLY
DESCRIPTION
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.
Calcitriol is available as capsules
containing 0.25 mcg or 0.5 mcg calcitriol All dosage forms contain
butylated hydroxyanisole (BHA)
and butylated hydroxytoluene (BHT) as antioxidants. The capsules
contain medium chain triglycerides.
Gelatin capsule shells contain glycerin, sorbitol, with the following
dye systems: 0.25-mcg FD&C
Yellow No. 6, FD&C red No.3 and titanium dioxide; 0.5 mcg- FD&C Yellow
No. 6, FD&C red No.3
and titanium dioxide. The imprinting ink contains propylene glycol,
shellac, black iron oxide, isopropyl
alcohol, N-butyl alcohol and ammonium hydroxide.
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-1α, 3β, 25-triol and has the
following structural formula:
CALCITRIOL
The other names frequently used for calcitriol are
lα,25-dihydroxycholecalciferol, 1, 25-
dihydroxyvitamin D , 1,25-DHCC, 1,25(OH) D and 1,25-diOHC.
CLINICAL PHARMACOLOGY
Man's natural supply of vitamin D depends mainly on exposure to the
ultraviolet rays of the sun for
conversion of 7-dehydrocholesterol in the skin to vitamin D
(cholecalciferol). Vitamin D must be
metabolically activated in the liver and the kidney before it is fully
active as a regulator of calcium and
phosphorus metabolism at target tissues. The initial transformation of
vitamin D is catalyzed by a
vitamin D -25-hydroxylase enzyme (25-OHase) present in the liver, and
the product of this reaction is
25-hydroxyvitamin D [25-(OH)D ]. Hydroxylation of 25-(OH)D occurs in
the mitochondria of kidney
tissue, activated by the renal 25-hydroxyvitamin