CALCITRIOL injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Physicians Total Care, Inc.

INN (Algemene Internationale Benaming):

CALCITRIOL

Samenstelling:

CALCITRIOL 1 mg in 1 mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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.

Product samenvatting:

Calcitriol Injection NDC 54868-6265-0    1 mcg/mL 1 mL ampules      Boxed in 25 IN0132 Rev. 11/07 MG #15726 AMERICAN REGENT, INC. SHIRLEY, NY 11967 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CALCITRIOL - CALCITRIOL INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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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 is available in 1 mL ampules.
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,
Monohydrate 1.8 mg; Edetate Disodium, Dihydrate 1.1 mg added; Water
for Injection q.s. pH range 6.7-
7.7.
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:
Molecular Formula: C
H O
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 t