DOXERCALCIFEROL- doxercalciferol injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DOXERCALCIFEROL (UNII: 3DIZ9LF5Y9) (DOXERCALCIFEROL - UNII:3DIZ9LF5Y9)

Tilgjengelig fra:

Sandoz Inc

INN (International Name):

DOXERCALCIFEROL

Sammensetning:

DOXERCALCIFEROL 2 ug in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. Doxercalciferol injection should not be given to patients with a tendency towards hypercalcemia or current evidence of vitamin D toxicity. Doxercalciferol injection is contraindicated in patients with previous hypersensitivity to doxercalciferol or any of its ingredients (see WARNINGS and ADVERSE REACTIONS ).

Produkt oppsummering:

Doxercalciferol injection is supplied in single-use amber glass vials containing 4 mcg doxercalciferol in 2 mL of solution or 2 mcg in 1 mL of solution. The closure consists of a fluorocarbon-coated chlorobutyl stopper, with an aluminum seal and either a yellow (4 mcg/2 mL) or gray (2 mcg/mL) plastic flip-off cap. Discard unused portion of single-use vial. NDC 0781-3304-95 - 2 mcg/mL vial in cartons of 10 vials. NDC 0781-3305-95 - 4 mcg/2 mL vial in cartons of 10 vials. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. 4612XXXX 06-2016M Manufactured in Canada by Sandoz Canada Inc. for Sandoz Inc., Princeton, NJ 08540

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DOXERCALCIFEROL- DOXERCALCIFEROL INJECTION, SOLUTION
SANDOZ INC
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DOXERCALCIFEROL INJECTION
DESCRIPTION
Doxercalciferol is a synthetic vitamin D analog that undergoes
metabolic activation _in vivo_ to form
1α,25-dihydroxyvitamin D (1α,25-(OH) D ), a naturally occurring,
biologically active form of vitamin
D . Doxercalciferol injection is supplied as either 4 mcg/2 mL or 2
mcg/mL, each in a stoppered, single
use 2 mL amber glass vial, with an aluminum seal and yellow (4 mcg/2
mL) or gray (2 mcg/mL) flip-off
cap. Doxercalciferol is available as a sterile, clear, essentially
colorless to faint yellow, aqueous
solution for intravenous injection. Each milliliter (mL) of solution
contains doxercalciferol, 2 mcg;
ethanol, 100%, 0.05 mL; Polysorbate 20, 10 mg; sodium chloride, 1.5
mg; butylated hydroxytoluene,
0.02 mg; sodium phosphate dibasic, heptahydrate, 14.4 mg; sodium
phosphate monobasic, monohydrate,
1.8 mg; and disodium edetate, 1.1 mg.
Doxercalciferol is a colorless crystalline compound with a calculated
molecular weight of 412.66 and
a molecular formula of C
H O . It is soluble in oils and organic solvents, but is relatively
insoluble
in water. Chemically, doxercalciferol is
(1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-
1,3-diol and has the following structural formula:
Other names frequently used for doxercalciferol are 1α-hydroxyvitamin
D , 1α-OH-D , and 1α-
hydroxyergocalciferol.
CLINICAL PHARMACOLOGY
Vitamin D levels in humans depend on two sources: (1) exposure to the
ultraviolet rays of the sun for
conversion of 7-dehydrocholesterol in the skin to vitamin D
(cholecalciferol) and (2) dietary intake of
either vitamin D (ergocalciferol) or vitamin D . Vitamin D and vitamin
D must be metabolically
activated in the liver and kidney before becoming fully active on
target tissues. The initial step in the
activation process is the introduction of a hydroxyl group in the side
chain at C-25 by the hepatic
enzyme, CYP 27 (a vitamin D-25-hydroxylase). The products of this
reaction are 25-