ergocalciferol (Ergocalciferol) capsule
[Banner Pharmacaps, Inc.]
ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration.
Refined soybean oil, gelatin, glycerin, purified water,
D&C Yellow #10, and FD&C Blue #1.
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 D2 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
One USP Unit of vitamin D2 is equivalent to one International Unit (IU), and 1
mcg of vitamin D2 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
Ergocalciferol, also called vitamin D2, is
9, 10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3β,5Z,7E,22E)-; (C28H44O)
with a molecular weight of 396.65, and has the following structural formula:
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
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 in the liver and
kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.
INDICATIONS AND USAGE
Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory
rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
CONTRAINDICATIONSErgocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome,
abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic
hypercalcemia. In these cases vitamin D must be strictly restricted.
Keep out of the reach of
GeneralVitamin D administration from fortified foods, dietary supplements, self-administered and
prescription drug sources should be evaluated. Therapeutic dosage should be readjusted as soon as
there is clinical improvement. Dosage levels must be individualized and great care exercised to
prevent serious toxic effects. IN VITAMIN D RESISTANT RICKETS THE RANGE BETWEEN THERAPEUTIC AND
TOXIC DOSES IS NARROW. When high therapeutic doses are used progress should be followed with
frequent blood calcium determinations.
In the treatment of hypoparathyroidism, intravenous calcium,
parathyroid hormone, and/or dihy-drotachysterol may be required.
Maintenance of a normal serum
phosphorous level by dietary phosphate restriction and/or administration of aluminum gels as
intestinal phosphate binders in those patients with hyperphosphatemia as frequently seen in renal
osteodystrophy is essential to prevent metastatis calcification.
Adequate dietary calcium is
necessary for clinical response to vitamin D therapy.
Protect from light.
Drug InteractionsMineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D
Administration of thiazide diuretics to hypoparathyroid patients who are concurrently
being treated with ergocalciferol may cause hypercalcemia.
Carcinogenesis, Mutagenesis, Impairment of FertilityNo long-term animal studies have been performed to evaluate the drug's potential in
Pregnancy Category C
Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic
stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized
by supravalvular aortic stenosis, elfin facies, and mental retardation. For the protection of the
fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a
specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP
units of vitamin D daily during pregnancy has not been established.
Nursing MothersCaution should be exercised when ergocalciferol is administered to a nursing woman.
In a mother given large doses of vitamin D, 25-hydroxycholecalciferol appeared in the milk and
caused hypercalcemia in her child. Monitoring of the infants serum calcium concentration is
required in that case (Goldberg, 1972).
Pediatric UsePediatric doses must be individualized (see DOSAGE AND ADMINISTRATION).
Clinical studies of Ergocalciferol capsules, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A few published reports have suggested that the absorption of orally administered vitamin D may be attenuated in elderly compared to younger, individuals. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONSHypervitaminosis D is characterized by effects on the following organ system:
Impairment of renal function with polyuria, nocturia, polydipsia,
hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized
vascular calcification, or irreversible renal insufficiency which may result
CNS: Mental retardation.
Widespread calcification of the soft tissues, including the heart,
blood vessels, renal tubules, and lungs.
Bone demineralization (osteoporosis) in adults occurs concomitantly.
Decline in the average rate of linear growth and increased mineralization
of bones in infants and children (dwarfism), vague aches, stiffness, and weakness.
Nausea, anorexia, constipation.
Mild acidosis, anemia, weight loss.
The effects of administered vitamin D can persist for two or more months after cessation
Hypervitaminosis D is characterized by:
The treatment of hypervitaminosis D with hypercalcemia consists in immediate withdrawal
of the vitamin, a low calcium diet, generous intake of fluids, along with symptomatic and
supportive treatment. Hypercalcemic crisis with dehydration, stupor, coma, and azotemia
requires more vigorous treatment. The first step should be hydration of the patient.
Intravenous saline may quickly and significantly increase urinary calcium excretion. A loop
diuretic (furosemide or ethacrynic acid) may be given with the saline infusion to further
increase renal calcium excretion. Other reported therapeutic measures include dialysis or the
administration of citrates, sulfates, phosphates, corticosteroids, EDTA
(ethylenediaminetetraacetic acid), and mithramycin via appropriate regimens.
With appropriate therapy, recovery is the usual outcome when no permanent damage has
occurred. Deaths via renal or cardiovascular failure have been reported.
- Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and
stiffness, constipation, mental retardation, anemia, and mild acidosis.
- Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria,
reversible azotemia, or irreversible renal insufficiency which may result in death.
- Widespread calcification of the soft tissues, including the heart, blood vessels,
renal tubules, and lungs. Bone demineralization (osteoporosis) in adults occurs
- Decline in the average rate of linear growth and increased mineralization of bones
in infants and children (dwarfism).
The LD50 in animals is unknown. The toxic oral dose of ergocalciferol
in the dog is 4 mg/kg.
DOSAGE AND ADMINISTRATION
THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.
Vitamin D Resistant Rickets:
12,000 to 500,000 USP units daily.
50,000 to 200,000 USP units daily concomitantly with calcium lactate 4 g, six
times per day.
DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.
Calcium intake should be adequate. Blood calcium and phosphorous
determinations must be made every 2 weeks or more frequently if necessary.
X-rays of the bones should be taken every month until condition is corrected and
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
100 or 1000 Softgels.
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.
Banner Pharmacaps, Inc.
4125 Premier Drive
High Point, NC27265
|Ergocalciferol (Ergocalciferol) |
|Route Of Administration
|Name (Active Moiety)
||1.25 MILLIGRAM In 1 CAPSULE
|D&C Yellow #10
|FD&C Blue #1
||100 CAPSULE In 1 BOTTLE, PLASTIC
||1000 CAPSULE In 1 BOTTLE, PLASTIC
Revised: 01/2008Banner Pharmacaps, Inc.
Data are from FDA and U.S. National Library of Medicine.