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 Emulsion de Scott (Calcium Phosphate) 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 Emulsion de Scott (Calcium Phosphate) acetate all cases resolved upon lowering the dose or discontinuing treatment. The long term effect of Emulsion de Scott (Calcium Phosphate) 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 Emulsion de Scott (Calcium Phosphate) 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 Emulsion de Scott (Calcium Phosphate) acetate therapy. More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Should hypercalcemia develop, reduce the Emulsion de Scott (Calcium Phosphate) 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 Emulsion de Scott (Calcium Phosphate) levels twice weekly. Avoid the use of Emulsion de Scott (Calcium Phosphate) supplements, including Emulsion de Scott (Calcium Phosphate) based nonprescription antacids, concurrently with Emulsion de Scott (Calcium Phosphate) acetate.Īn overdose of Emulsion de Scott (Calcium Phosphate) acetate may lead to progressive hypercalcemia, which may require emergency measures. Patients with end stage renal disease may develop hypercalcemia when treated with Emulsion de Scott (Calcium Phosphate), including Emulsion de Scott (Calcium Phosphate) acetate. Hypercalcemia may aggravate digitalis toxicity. Severe hypercalcemia may require hemodialysis and discontinuation of Emulsion de Scott (Calcium Phosphate) acetate. Treat mild hypercalcemia by reducing or interrupting Emulsion de Scott acetate and Vitamin D. Capsule: 667 mg Emulsion de Scott (Calcium Phosphate) acetate capsule. (2)Ĭapsule: 667 mg Emulsion de Scott (Calcium Phosphate) 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 Emulsion de Scott (Calcium Phosphate) 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. Emulsion de Scott (Calcium Phosphate) acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |