ERGOCALCIFEROL capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aphena Pharma Solutions - Tennessee, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Each green, oval softgel capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP. NDC 51407-143-12 Bottles of 12 Softgel Capsules NDC 51407-143-13 Bottles of 13 Softgel Capsules NDC 51407-143-01 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. 750 Route 202, Bridgewater, NJ 08807 USA Revision: 01/2018 Marketed/Packaged by: GSMS, Inc Camarillo, CA 93012 USA

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ERGOCALCIFEROL- ERGOCALCIFEROL CAPSULE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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
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
2
2
2
2
28
44
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