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:

Bryant Ranch Prepack

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 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 hypoparathyroidism, and pseudohypoparathyroidism. Calcitriol should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of calcitriol in patients with known hypersensitivity to calcitriol (or drugs of the same class) or any of the inactive ingredients is contraindicated.

Ringkasan produk:

Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with CAL1 in black ink. Calcitriol Capsules should be protected from light. Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

CALCITRIOL- CALCITRIOL CAPSULE, LIQUID FILLED
BRYANT RANCH PREPACK
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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
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processe