CALCITRIOL- calcitriol capsule, liquid filled

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

NuCare Pharmaceuticals,Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 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 hypoparathyroidism, an

Ringkasan produk:

Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with H118 in black ink. NDC 68071-4487-9 BOTTLES OF 90 Calcitriol Capsules should be protected from light. Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, New Jersey 07724 1.866.901.DRUG (3784) Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265 Rev. 06/13

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CALCITRIOL- CALCITRIOL CAPSULE, LIQUID FILLED
NUCARE PHARMACEUTICALS,INC.
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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-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 these processes, play a
critical role