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:

Bryant Ranch Prepack

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. 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. Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. C

Resumen del producto:

Calcitriol capsules are available as follows: 0.5 mcg - opaque, brown and pink, two-tone, oblong, soft, gelatin capsules, imprinted “93” and “658”, Product: 71335-1594 NDC: 71335-1594-1 30 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1594-2 8 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1594-3 28 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1594-4 90 CAPSULE, LIQUID FILLED in a BOTTLE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CALCITRIOL- CALCITRIOL CAPSULE, LIQUID FILLED
BRYANT RANCH PREPACK
----------
CALCITRIOL CAPSULES, 0.25 MCG AND 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. It is available as
capsules containing 0.25 mcg or 0.5 mcg calcitriol. Each capsule also
contains the
following inactive ingredients: butylated hydroxyanisole (BHA) and
butylated
hydroxytoluene (BHT) as antioxidants, and triglycerides (medium
chain). Gelatin capsule
shell contains gelatin, glycerol, mannitol, red iron oxide,
sorbitanhydrides, sorbitol,
superior polyols, titanium dioxide and yellow iron oxide. Imprinting
ink contains
propylene glycol, shellac modified, and titanium dioxide.
Calcitriol is a white, crystalline compound which occurs naturally in
humans. It 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:
C
H
O M.W. 416.65
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
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 D -1 alpha-hydroxylase
(alpha-OHase), to
27
44
3
3
2
3
3
3
3
3
3
3
3
3
produce 1,25-(OH) D (calcitriol), the active form of