OTE: This monograph discusses the contraindications/precautions of calcium; vitamin D as a combination dietary supplement used to prevent or treat calcium deficiency and osteoporosis. Clinicians may wish to consult the individual monographs for more information about each agent.
Calcium; vitamin D should not be used in patients with vitamin D hypersensitivity or hypersensitivity to any of the excipients in the formulation. Certain formulations may contain FD&C yellow dye No. 5 (tartrazine); these formulations should not be used in patients with tartrazine dye hypersensitivity.
Calcium; vitamin D should not be given to patients with hypercalcemia or hypervitaminosis D. Hypercalcemia can lead to soft tissue calcification and other toxicities.
Calcium; vitamin D should be administered with caution to patients with preexisting dehydration. These patients are predisposed to developing milk-alkali syndrome when taking calcium. Symptoms of this syndrome include hypercalcemia, nausea/vomiting, headache, weakness, metabolic alkalosis, and changes in mental status.
Calcium; vitamin D should be administered with caution in patients with renal disease (i.e., CrCl less than 30 ml/min) to avoid elevations of calcitonin-phosphorus ion products and further development of calcinosis. Calcium; vitamin D is contraindicated in patients with kidney stones (nephrolithiasis) and in patients with hypercalciuria that cannot be controlled with a thiazide diuretic. Patients with a urinary calcium excretion of more than 300 mg/24 hr should not take calcium and vitamin D. Caution should also be observed when administering calcium; vitamin D in patients with hyperphosphatemia due to the risk of metastatic calcification, and it should be avoided in patients with renal osteodystrophy with hyperphosphatemia. Excessive doses of calcium; vitamin D, acutely or for a prolonged period, can eventually, result in vitamin D-induced hypercalcemia manifested as nephrocalcinosis and other calcifications. These adverse reactions can be significant in patients with renal failure, even with usual dosages.
Calcium; vitamin D should be used cautiously in patients with peptic ulcer disease, GI bleeding, GI obstruction or ileus, constipation, or decreased gastric motility. Administration of calcium can cause gastric hypersecretion and acid rebound. Use with caution in patients with hepatic disease, gallbladder disease, biliary tract disease, or other GI disease including malabsorption syndrome. Higher doses of vitamin D may be needed to compensate for reductions in hepatic hydroxylation and decreases in intestinal absorption due to a lack of adequate bile production. Active vitamin D analogs may be preferred in such cases.
Calcium; vitamin D should be administered with caution to patients with cardiac disease or those receiving digoxin, as hypercalcemia with cardiac arrhythmias can result.
Patients with sarcoidosis, and possibly other granulomatous diseases, may have increased sensitivity to the effects of vitamin D in calcium; vitamin D combination products. Use with caution.
Calcium; vitamin D should be used with caution in patients with hypoparathyroidism; dihydrotachysterol or parathyroid hormone may need to be added to therapy.
Clinical studies of vitamin D do not include sufficient numbers of geriatric subjects 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. Individualize dosage of combination calcium; vitamin D based on indication and clinical response.
Vitamin D is classified as FDA pregnancy risk category C; dietary supplements of cholecalciferol should be treated similarly with respect to pregnancy. Adverse effects have not been reported with the normal daily intake of Vitamin D within the recommended dietary daily intakes for a pregnant female.[31028] Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D, so over supplementation must be avoided during pregnancy since there is a relatively low range between therapeutic and toxic dosages. 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 IU of vitamin D daily during pregnancy has not been established. Adverse effects have not been reported with the normal daily intake of calcium within the recommended dietary daily intakes for a pregnant female.[31028] The use of calcium salts 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.[31028]
Calcium appears to be safe and effective to use during breast-feeding to help meet maternal nutritional requirements. Human breast milk naturally contains calcium and other minerals; maternal calcium intake appears to have no significant effect on the amount of calcium normally found in human milk.[27966] [31028] Vitamin D is distributed in small amounts into human milk. The American Academy of Pediatrics (AAP) generally considers Vitamin D compatible with breast-feeding, but recommends that serum calcium concentrations in the breast-feeding infant should be monitored when large doses of vitamin D are prescribed in a nursing mother since hypercalcemia has been reported with high dose maternal use.[27500] [30166] The active metabolite, 25-hydroxyergocalciferol, may be distributed into breast milk.[36897] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
[Revised : 2012-03-16 11:20:00]
References
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