Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
Paddock Laboratories, LLC
CALCIUM ACETATE
CALCIUM ACETATE 667 mg
ORAL
PRESCRIPTION DRUG
Calcium Acetate Tablets, USP are indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption. Patients with hypercalcemia.
In tablet form with "P113" debossed on one side and plain on the other, for oral administration. Each white round tablet contains 667 mg calcium acetate (anhydrous; Ca(CH3 COO)2 ; MW = 158.17 grams) equal to 169 mg (8.45 mEq) calcium; polyethylene glycol 8000; and magnesium stearate. Tablets, NDC 0574-0113-02, bottles of 200. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Rx Only Manufactured By Perrigo® Minneapolis, MN 55427 2202147 (12-12)
Abbreviated New Drug Application
CALCIUM ACETATE- CALCIUM ACETATE TABLET PADDOCK LABORATORIES, LLC ---------- CALCIUM ACETATE TABLETS, USP NDC 0574-0113-02 RX ONLY DES CRIPTION: Each white to off-white, round, biconvex tablet (debossed with "P113" on one face) 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; and magnesium stearate. Calcium Acetate Tablets, 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, 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. Calcium Acetate Tablets, USP are 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 Прочитайте повний документ