Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
Safecor Health, 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 in unit dose blisters, NDC 48433-300-01; Box of 100 (NDC 48433-300-10) unit dose Robot-Rx® 1 pouches; Box of 75 (NDC 48433-300-75) unit dose Robot-Rx®1 pouches The product contained in these packages is from NDC 00574-0113. This package is not child resistant. For institutional use only. Packaged and Distributed by: Safecor Health, LLC 317 New Boston Street Woburn, MA 01801 Safecor Health, LLC 4060 Business Park Drive Columbus, OH 43204 Questions or comments? 1-800-447-1006 Rev: 114-00 09/2014 Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]
Abbreviated New Drug Application
CALCIUM ACETATE- CALCIUM ACETATE TABLET SAFECOR HEALTH, LLC ---------- CALCIUM ACETATE TABLETS, USP 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 has been demonstrated to be sy Baca dokumen lengkapnya