openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
WARNINGS Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with ELIPHOS ® . Progressive hypercalcemia due to overdose of ELIPHOS ® may be severe as to require emergency measures. Chronic hypercalcemia may lead to vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period. The serum calcium times phosphate (CaXP) product should not be allowed to exceed 66. Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft-tissue calcification.
ADVERSE REACTIONS In clinical studies, patients have occasionally experienced nausea during calcium acetate tablet therapy. Hypercalcemia may occur during treatment with ELIPHOS ® . Mild hypercalcemia (Ca>10.5mg/dL) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca>12mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the ELIPHOS ® dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate tablets therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of ELIPHOS ® induced hypercalcemia. The long-term effect of calcium acetate tablets on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.