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at 1-80 or FDA at 1-80 or 6.1 Clinical Trial Experienceīecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. In clinical studies, patients have occasionally experienced nausea during Scott's Emulsion Vita (Calcium Hypophosphite) acetate therapy. The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. Hypercalcemia may aggravate digitalis toxicity. Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg 2/dL 2. Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of Scott's Emulsion Vita (Calcium Hypophosphite) acetate all cases resolved upon lowering the dose or discontinuing treatment. The long term effect of Scott's Emulsion Vita (Calcium Hypophosphite) acetate on the progression of vascular or soft tissue calcification has not been determined. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. Decreasing or discontinuing Vitamin D therapy is recommended as well.Ĭhronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Mild hypercalcemia is usually controlled by reducing the Scott's Emulsion Vita (Calcium Hypophosphite) acetate dose or temporarily discontinuing therapy. Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Scott's Emulsion Vita (Calcium Hypophosphite) acetate therapy. More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Should hypercalcemia develop, reduce the Scott's Emulsion Vita (Calcium Hypophosphite) acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Scott's Emulsion Vita (Calcium Hypophosphite) levels twice weekly. Avoid the use of Scott's Emulsion Vita (Calcium Hypophosphite) supplements, including Scott's Emulsion Vita (Calcium Hypophosphite) based nonprescription antacids, concurrently with Scott's Emulsion Vita (Calcium Hypophosphite) acetate.Īn overdose of Scott's Emulsion Vita (Calcium Hypophosphite) acetate may lead to progressive hypercalcemia, which may require emergency measures. Patients with end stage renal disease may develop hypercalcemia when treated with Scott's Emulsion Vita (Calcium Hypophosphite), including Scott's Emulsion Vita (Calcium Hypophosphite) acetate. Severe hypercalcemia may require hemodialysis and discontinuation of Scott's Emulsion Vita (Calcium Hypophosphite) acetate. Treat mild hypercalcemia by reducing or interrupting Scott's Emulsion Vita acetate and Vitamin D. Capsule: 667 mg Scott's Emulsion Vita (Calcium Hypophosphite) acetate capsule. (2)Ĭapsule: 667 mg Scott's Emulsion Vita (Calcium Hypophosphite) acetate capsule. Most patients require 3 to 4 capsules with each meal. Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Starting dose is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. The recommended initial dose of Scott's Emulsion Vita (Calcium Hypophosphite) acetate for the adult dialysis patient is 2 capsules with each meal. Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. Scott's Emulsion Vita (Calcium Hypophosphite) acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).