Calcium Acetate Gelcaps

Capsule: 667 mg calcium acetate per capsule.

Patients with hypercalcemia.

5.1 Hypercalcemia

Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate. Avoid the use of calcium supplements, including calcium-based nonprescription antacids, concurrently with Calcium Acetate.
 

An overdose of Calcium Acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly. Should hypercalcemia develop, reduce the Calcium Acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia.
 

More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Calcium Acetate therapy.
 

Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the Calcium Acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.
 

Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of Calcium Acetate on the progression of vascular or soft tissue calcification has not been determined.
 

Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3-month study of solid dose formulation of calcium acetate; all cases resolved upon lowering the dose or discontinuing treatment.

Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2 /dL2 .

5.2 Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

13.1 Carcinogenesis, Mutagenesis, Impairment and Fertility

No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.