CALCITRIOL- calcitriol capsules 0.25 mcg capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

American Health Packaging

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Calcitriol capsule 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 capsule 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 capsule is 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.

Tóm tắt sản phẩm:

Capsules: 0.25 mcg calcitriol in soft gelatin, orange, oval capsules, imprinted with 673; unit dose packages of 100 (10 x 10) NDC 68087-345-01 Calcitriol Capsules should be protected from light. Store at 20° to 25°C (68° to 77°C F) [See USP Controlled Room Temperature] FOR YOUR PROTECTION: Do not use if blister if torn or broken.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

CALCITRIOL- CALCITRIOL CAPSULES 0.25 MCG CAPSULE
AMERICAN HEALTH PACKAGING
----------
CALCITRIOL CAPSULES
8434501/1017
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 All
dosage forms contain
butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as
antioxidants.
The capsules contain medium chain triglycerides. Gelatin capsule
shells contain glycerin,
sorbitol, with the following dye systems: 0.25-mcg FD&C Yellow No. 6,
FD&C red No.3
and titanium dioxide; 0.5 mcg- FD&C Yellow No. 6, FD&C red No.3 and
titanium dioxide.
The imprinting ink contains propylene glycol, shellac, black iron
oxide, isopropyl alcohol,
N-butyl alcohol and ammonium hydroxide.
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
lα,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-