CALCITRIOL solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

NEPHRX, LLC

INN (International ime):

Calcitriol

Farmaceutski oblik:

SOLUTION

Sastav:

1 ug in 1 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Calcitriol Injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Calcitriol Injection should not be given to patients with hypercalcemia or evidence of vitamin D toxicity.

Proizvod sažetak:

Calcitriol Injection is supplied as follows: PROTECT FROM LIGHT . Store at controlled room temperature 15o to 30o C (59o to 86o F). Rx Only Printed in USA NEPHRX 2007 Distributed by: NEPHRX, LLC, Brockton, MA 02301, USA R5-10/07

Svojstava lijeka

CALCITRIOL- CALCITRIOL SOLUTION
NEPHRX, LLC
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CALCITRIOL INJECTION
1 MCG/ML
DESCRIPTION
Calcitriol Injection is synthetically manufactured calcitriol and is
available as a sterile, isotonic, clear,
colorless to yellow, aqueous solution for intravenous injection.
Calcitriol Injection is available in 1 mL
ampuls. Each 1 mL contains calcitriol, 1 mcg; Polysorbate 20, 4 mg;
sodium chloride 1.5 mg; sodium
ascorbate 10 mg added; dibasic sodium phosphate, anhydrous 7.6 mg;
monobasic sodium phosphate,
dihydrate 2.0 mg; edetate disodium, dihydrate 1.1 mg added. pH 7.2
(6.5 to 8.0).
Calcitriol is a crystalline compound, which occurs naturally in
humans. It is soluble in organic solvents
but relatively insoluble in water.
Calcitriol is chemically designated (5Z,7E)-9,
10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol and has
the following structural formula:
The other names frequently used for calcitriol are
1α,25-dihydroxycholecalciferol, 1α,25-
dihydroxyvitamin D , 1,25-DHCC, 1,25(OH) D , and 1,25-diOHC.
CLINICAL PHARMACOLOGY
Calcitriol is the active form of vitamin D (cholecalciferol). The
natural or endogenous supply of
vitamin D in man mainly depends on ultraviolet light for conversion of
7-dehydrocholesterol to vitamin
D in the skin. Vitamin D must be metabolically activated in the liver
and the kidney before it is fully
active on its target tissues. The initial transformation is catalyzed
by a vitamin D -25-hydroxylase
enzyme present in the liver, and the product of this reaction is
25-(OH)D (calcifediol). The latter
undergoes hydroxylation in the mitochondria of kidney tissue, and this
reaction is activated by the renal
25-hydroxyvitamin D -1-α-hydroxylase to produce 1,25-(OH) D
(calcitriol), the active form of vitamin
D .
The known sites of action of calcitriol are intestine, bone, kidney
and parathyroid gland. Calcitriol is the
most active known form of vitamin D in stimulating intestinal calcium
transport. In acutely uremic rats,
calcitriol has been shown to stimulate intestinal calcium absorption.
I