VITAMIN D- ergocalciferol capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

ERGOCALCIFEROL

Composition:

ERGOCALCIFEROL 1.25

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with '194' in white and contain clear light yellow oily liquid. Bottles of 06 capsules (NDC: 63187-519-06) Bottles of 08 capsules (NDC: 63187-519-08) Bottles of 12 capsules (NDC: 63187-519-12) Bottles of 16 capsules (NDC: 63187-519-16) Bottles of 30 capsules (NDC: 63187-519-30) Bottles of 60 capsules (NDC: 63187-519-60) Bottles of 90 capsules (NDC: 63187-519-90) Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured By: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed By: Strides Pharma Inc 201 South Main Street, Suite 3 Lambertville, NJ 08530 USA (06-2014) Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VITAMIN D- ERGOCALCIFEROL CAPSULE
PROFICIENT RX LP
----------
VITAMIN D (ERGOCALCIFEROL CAPSULES, USP)
1.25MG (50,000 USP UNITS)
EACH CAPSULE CONTAINS VITAMIN D (ERGOCALCIFEROL) 1.25 MG EQUIVALENT TO
50,000
USP UNITS.
DESCRIPTION
Ergocalciferol Capsules, USP are 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 USP Units.
Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to
50,000 USP Units
in an edible vegetable oil.
Ergocalciferol, also called vitamin D , is
9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol,
(3β,5Z,7E,22_E_)-; (C
H
O) with a molecular weight of 396.65, and has the following
structural formula:
_INACTIVE INGREDIENTS:_ 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5,
Gelatin,
Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac
glaze (modified) IN
SD-45, Simethicone, Soybean oil and Titanium dioxide.
CLINICAL PHARMACOLOGY
The in vivo synthesis of the major biologically active metabolites of
vitamin D occurs in
2
2
2
2
28
44
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 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