CALCITRIOL solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

Calcitriol (UNII: FXC9231JVH) (Calcitriol - UNII:FXC9231JVH)

Предлага се от:

Patrin Pharma, Inc

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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. 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.

Каталог на резюме:

Calcitriol Oral Solution is a clear, colorless oral solution supplied in an amber 15 mL bottle containing 1 mcg/mL of calcitriol; Each bottle is accompanied by 20 single-use, graduated oral dispensers (NDC 39328-042-15). Calcitriol Oral Solution should be protected from light. Store at controlled room temperature 20-25°C (68°- 77°F). Excursions permitted 15° - 30°C (59-85°F).

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CALCITRIOL- CALCITRIOL SOLUTION
PATRIN PHARMA, INC
----------
CALCITRIOL - CALCITRIOL ORAL SOLUTION
PATRIN PHARMA, INC.
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 an oral solution containing 1 mcg/mL of calcitriol. All
dosage forms contain
butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as
antioxidants.
The oral solution contains a fractionated triglyceride of palm seed
oil.
The oral solution contains no additional adjuvants or coloring
principles.
Calcitriol is a white or almost 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 D3 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)D3 occurs in the mitochondria of
kidney tissue,
activated by the renal 25-hydroxyvitamin D3-1 alpha-hydroxylase
(alpha-OHase), to
produce 1,25-(OH) D (calcitriol), the active form of vitamin D .
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Endogenous synthesis and catabolism of calcitriol, as well as
physiological control
mechanisms affecting t