CALCITRIOL capsule, liquid filled

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Sun Pharmaceutical Industries, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Predialysis Patients Calcitriol 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. Dialysis Patients Calcitriol 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. Hypoparathyroidism Patients Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgic

Resumen del producto:

Calcitriol capsules are available as follows: 0.25 mcg - peach colored oval, soft gelatin capsule imprinted with ‘967’ in black ink, containing clear, colorless to slightly yellowish oily liquid. Bottles of 30 with child-resistant cap…………………..NDC 62756-967-83 Bottles of 100 with child-resistant cap…………………NDC 62756-967-88 Bottles of 1000.............................................……….….NDC 62756-967-18 0.5 mcg - brown colored oval, soft gelatin capsule imprinted with ‘968’ in black ink, containing clear, colorless to slightly yellowish oily liquid. Bottles of 30 with child-resistant cap…………………..NDC 62756-968-83 Bottles of 100 with child-resistant cap………………..NDC 62756-968-88 Bottles of 1000..........................................……….….NDC 62756-968-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Calcitriol Capsules should be protected from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CALCITRIOL - CALCITRIOL CAPSULE, LIQUID FILLED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
CALCITRIOL CAPSULES
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, USP.
Each capsule
contains butylated hydroxyanisole (BHA) and butylated hydroxytoluene
(BHT) as
antioxidants, and medium-chain triglycerides. Gelatin capsule shells
contain gelatin,
glycerin, noncrystallizing sorbitol solution, methyl paraben and
propyl paraben with the
following dye systems:
0.25 mcg –ferric oxide red, ferric oxide yellow and titanium
dioxide; 0.5 mcg –ferric
oxide red and titanium dioxide. The imprinting ink contains shellac,
black iron oxide, N-
butyl alcohol, propylene glycol, ammonium hydroxide. Calcitriol is a
white, crystalline
compound which occurs naturally in humans. It has a calculated
molecular weight of
416.6 and is practically insoluble in water, soluble in alcohol and
fatty oils. Chemically,
calcitriol is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β,
25-triol and has the
following structural formula:
The other names frequently used for calcitriol are
1α,25-dihydroxycholecalciferol, 1,25-
dihydroxyvitamin D , 1,25-DHCC, 1,25(OH) D and 1,25-diOHC.
CLINICAL PHARMACOLOGY
3
2
3
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 rena