País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
KAISER FOUNDATION HOSPITALS
CALCIUM ACETATE
CALCIUM ACETATE 667 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ELIPHOS- CALCIUM ACETATE TABLET KAISER FOUNDATION HOSPITALS ---------- DESCRIPTION Each white, round tablet (stamped “CYP910”) contains 667 mg calcium acetate, USP (anhydrous; Ca(CH COO) ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000 NF; sodium lauryl sulfate, NF; and crospovidone, NF. ELIPHOS (Calcium Acetate, USP) are administered orally for the control of hyperphosphatemia in end stage renal failure. CLINICAL PHARMACOLOGY Patients with advanced renal insufficiency (creatinine clearance less than 30 mL/min) exhibit phosphate retention and some degree of hyperphosphatemia. The retention of phosphate plays a pivotal role in causing secondary hyperparathyroidism associated with osteodystrophy, and soft-tissue calcification. The mechanism by which phosphate retention leads to hyperparathyroidism is not clearly delineated. Therapeutic efforts directed toward the control of hyperphosphatemia include reduction in the dietary intake of phosphate, inhibition of absorption of phosphate in the intestine with phosphate binders, and removal of phosphate from the body by more efficient methods of dialysis. The rate of removal of phosphate by dietary manipulation or by dialysis is insufficient. Dialysis patients absorb 40% to 80% of dietary phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet needs to be reduced by using phosphate binders in most renal failure patients on maintenance dialysis. Calcium acetate (ELIPHOS ) when taken with meals, combines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. ELIPHOS is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine. Orally administered calcium acetate from pharmaceutical dosage forms has been demonstrated to be systemically absorbed up to approximately 40% under f Llegiu el document complet