A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Calciferol Warnings, Precautions, Pregnancy, Nursing, Abuse - Ergocalciferol
Calciferol Warnings, Precautions, Pregnancy, Nursing, Abuse - Ergocalciferol
WARNINGS
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 children.
PRECAUTIONS
General Vitamin Dadministration 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 dihydrotachysterol
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 lnteractions
Mineral oil interferes
with the absorption
of fat-soluble vitamins, including vitamin
D preparations. Administration of thiazide diuretics to hypoparathyroid
patients who are concurrently being treated with ergocalciferol
may cause hypercalcemia.
Carclnogenesis, Mutagenesis, Impairment of Fertility
No long-term animal
studies have been performed to evaluate the drug’s potential in
these areas.
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 facie,
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 Mothers
Caution 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 infant’s serum
calcium concentration
is required in that case
(Goldberg, 1972).
Pediatric Use
Pediatric doses must be individualized (see DOSAGE
AND ADMINISTRATION).
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