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:

Aphena Pharma Solutions - Tennessee, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Calcitriol capsules are 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 capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules 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 capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyro

Resumen del producto:

Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with CAL1 in black ink; bottles of 30 (NDC 51407-169-30), and bottles of 100 (NDC 51407-169-01). Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange-red, oval capsules, imprinted with CAL2 in black ink; bottles of 100 (NDC 51407-170-01). Capsules should be protected from light. Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured for: Bionpharma Inc. 600 Alexander Road Princeton, NJ 08540, USA Rev. 05/18 Marketed/Packaged by: GSMS, Inc Camarillo, CA 93012 USA

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CALCITRIOL- CALCITRIOL CAPSULE, LIQUID FILLED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
CALCITRIOL CAPSULE, LIQUID FILLED
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
Capsules contain 0.25 mcg or 0.5 mcg calcitriol, fractionated
triglyceride of coconut oil,
butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as
antioxidants.
Gelatin capsule shells contain glycerin, water, sorbitol, sorbitan,
mannitol, water, FD&C
Yellow No. 6, FD&C Red #40, titanium dioxide and iron oxide black.
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:
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-
3
2
3
3
3
3
3
3
3
3
3
hydroxylase (alpha-OHase), to produce 1,25-(OH)
D
(calcitriol), the active form of
vitamin D
. Endogenous synthesis and catabolism of calcitriol, as well as
physiological
control mechanisms affecting