ERGOCALCIFEROL capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Alembic Pharmaceuticals Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia. Ergocalciferol Capsules, USP are 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 capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP. NDC 62332-464-31 Bottles of 100 Softgel Capsules Store at 20°- 25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Swiss Caps AG Kirchberg, Switzerland Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revision: 08/2021

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ERGOCALCIFEROL - ERGOCALCIFEROL CAPSULE
ALEMBIC PHARMACEUTICALS INC.
----------
VITAMIN D
(ERGOCALCIFEROL CAPSULES, USP) 1.25 MG
(50,000 USP UNITS )
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 capsule, 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
, (3β, 5_Z_, 7_E_, 22_E_) -; (C
H
O) with a molecular weight of 396.65, and has the following
structural formula:
INACTIVE INGREDIENTS : D&C Yellow No. 10, FD&C Blue No. 1, Gelatin,
Glycerin, Purified
Water, Refined Soybean Oil.
CLINICAL PHARMACOLOGY
2
2
2
2
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44
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-dihydroxy-
vitamin D). Vitamin
D metabolites promote the active absorption of calcium and phosphorus
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 necess