CALCITRIOL injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

West-ward Pharmaceutical Corp

INN (International Name):

CALCITRIOL

Sammensetning:

CALCITRIOL 1 ug in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Calcitriol Injection is supplied as follows: Store at 20 to 25ºC (68 to 77ºF) [See USP Controlled Room Temperature]. Protect from light.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CALCITRIOL- CALCITRIOL INJECTION
WEST-WARD PHARMACEUTICAL CORP
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CALCITRIOL INJECTION
RX ONLY
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
ampules. Each 1 mL contains calcitriol 1 mcg; polysorbate 20, 4 mg;
edetate disodium dehydrate 1.1 mg;
sodium phosphate dibasic 7.6 mg; sodium phosphate monobasic 1.8 mg;
sodium chloride 1.5 mg;
sodium ascorbate 10 mg. pH 6.6 (5.9 - 7.0).
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-1-(alpha),3 (beta),25-triol and has the following
structural formula:
Molecular Formula: C
H O
The other names frequently used for calcitriol are
1(alpha),25-dihydroxycholecalciferol, 1(alpha),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-(alpha)-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
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most active known form of vitamin D in stimulating intestinal calcium
transport. In acutely uremic rats,
calcitri