ERGOCALCIFEROL capsule, liquid filled

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC)

Διαθέσιμο από:

NuCare Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

ERGOCALCIFEROL

Σύνθεση:

ERGOCALCIFEROL 1.25 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia. Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Περίληψη προϊόντος:

Each green, oval softgel is imprinted with PA140 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP, and is available in bottles of 8 NDC 68071-1951-8 bottles of 4 NDC 68071-1951-4 bottles of 12 NDC 68071-1951-2 Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86 ° F) [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured for: Bionpharma Inc. 600 Alexander Road Princeton, NJ 08540, USA Rev. 12/2015

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ERGOCALCIFEROL- ERGOCALCIFEROL CAPSULE, LIQUID FILLED
NUCARE PHARMACEUTICALS, INC.
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ERGOCALCIFEROL CAPSULES, USP
RX ONLY
DESCRIPTION
ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for
oral
administration.
Ergocalciferol is a white, colorless crystal, insoluble in water,
soluble in organic solvents,
and slightly soluble in vegetable oils. It is affected by air and by
light. Ergosterol or
provitamin D
is found in plants and yeast and has no antirachitic activity.
There are more than 10 substances belonging to a group of steroid
compounds,
classified as having vitamin D or antirachitic activity.
One USP Unit of vitamin D
is equivalent to one International Unit (IU), and 1 mcg of
vitamin D
is equal to 40 IU.
Each softgel, for oral administration, contains Ergocalciferol, USP
1.25 mg (equivalent to
50,000 USP units of Vitamin D), in an edible vegetable oil.
Ergocalciferol, also called vitamin D
, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3
_β_,5 _Z_,7 _E_,22 _E_)-; (C
H
O) with a molecular weight of 396.65, and has the following
structural formula:
INACTIVE INGREDIENTS: Refined soybean oil, gelatin, glycerin, purified
water, D&C Yellow
#10, and FD&C Blue #1.
CLINICAL PHARMACOLOGY
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2
2
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The _in vivo_ synthesis of the major biologically active metabolites
of vitamin D occurs in
two steps. The first hydroxylation of ergocalciferol takes place in
the liver (to 25-
hydroxyvitamin D) and the second in the kidneys (to
1,25-dihydroxyvitamin D). Vitamin
D metabolites promote the active absorption of calcium and phosphorous
by the small
intestine, thus elevating serum calcium and phosphate levels
sufficiently to permit bone
mineralization. Vitamin D metabolites also mobilize calcium and
phosphate from bone
and probably increase the reabsorption of calcium and perhaps also of
phosphate by
the renal tubules.
There is a time lag of 10 to 24 hours between the administration of
vitamin D and the
initiation of its action in the body due to the necessity of synthesis
of the active
metabolites i