DOXERCALCIFEROL injection

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Hikma Pharmaceuticals USA Inc.

INN (Tarptautinis Pavadinimas):

DOXERCALCIFEROL

Sudėtis:

DOXERCALCIFEROL 2 ug in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 ).

Produkto santrauka:

Doxercalciferol Injection is available in the following package: 4 mcg/2 mL (2 mcg/mL), 2 mL pre-scored amber ampuls packaged in 25s (NDC 0641-6154-25) Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F)  [See USP Controlled Room Temperature]. Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD A Hikma Company Eatontown, NJ 07724 USA PIN349-WES/2 Revised July 2016

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DOXERCALCIFEROL- DOXERCALCIFEROL INJECTION
HIKMA PHARMACEUTICALS USA INC.
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DOXERCALCIFEROL INJECTION
Rx only
DESCRIPTION
Doxercalciferol, the active ingredient in Doxercalciferol Injection,
is a synthetic vitamin D analog that
undergoes metabolic activation _in vivo_ to form
1a,25-dihydroxyvitamin D (1a,25-(OH) D ), a naturally
occurring, biologically active form of vitamin D . Doxercalciferol
injection is available as a sterile,
clear, colorless aqueous solution for intravenous injection.
Doxercalciferol single-use injection is supplied in a 2 mL amber glass
ampul containing 4 mcg/2 mL or
2 mcg/mL. Each milliliter (mL) of solution contains doxercalciferol, 2
mcg; Polysorbate 20, 4 mg;
sodium chloride, 1.5 mg; sodium ascorbate, 10 mg; sodium phosphate,
dibasic, anhydrous 7.6 mg;
sodium dihydrogen phosphate, dihydrate, 2.34 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 structural formula presented in Figure 1.
FIGURE 1: CHEMICAL STRUCTURE OF DOXERCALCIFEROL
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-(OH)D and 25-
2
2
2
2
2