"As required by the bipartisan FDA Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today proposed a rule that would require the largest food businesses in the United States and abroad to take steps to prevent facilities"...
The difference between therapeutic dose and intoxicating dose may be small in any patient and therefore dosage must be individualized and periodically reevaluated.
In patients with renal osteodystrophy accompanied by hyperphosphatemia, maintenance of a normal serum phosphorus level by dietary phosphate restriction and/or administration of aluminum gels as intestinal phosphate binders is essential to prevent metastatic calcification.
Because of its effect on serum calcium, dihydrotachysterol should be administered to pregnant patients or to patients with renal stones only when, in the judgment of the physician, the potential banefits outweigh the possible hazards.
Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with dihydrotachysterol may cause hypercalcemia.
Teratogenic Effects -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.
There are no adequate and well-controlled studies in pregnant women. Dihydrotachysterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dihydrotachysterol is a administered to a nursing woman.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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