Country: Canada
Language: English
Source: Health Canada
CALCIUM ACETATE
FRESENIUS MEDICAL CARE NORTH AMERICA
V03AE
DRUGS FOR TREATMENT OF HYPERKALEMIA AND HYPERPHOSPHATEMIA
667MG
TABLET
CALCIUM ACETATE 667MG
ORAL
200
Prescription
PHOSPHATE-REMOVING AGENTS
Active ingredient group (AIG) number: 0123586005; AHFS:
CANCELLED POST MARKET
2013-07-29
PRODUCT MONOGRAPH PR PHOSLO ® (Calcium Acetate) Oral Tablets Phosphate Binder Manufactured for: Fresenius Medical Care North America Waltham, MA 02451 USA Distributed by: Fresenius Medical Care Canada, Inc Richmond Hill, ON, L4B 4W6 Canada 1-888-709-4411 Date of Preparation: February 20, 2007 Control Number: 112003 Page 1 of 15 NAME OF DRUG PhosLo Calcium Acetate 667 mg Tablets THERAPEUTIC CLASSIFICATION Phosphate Binder ACTIONS AND CLINICAL PHARMACOLOGY When taken with meals, PhosLo (calcium acetate) combines with dietary phosphate to form insoluble calcium phosphate, which is excreted in the feces. PhosLo is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine. Calcium acetate is a more efficient phosphate binder than other calcium salts. When phosphate binding in the proximal small intestinal lumen occurs, the calcium available for absorption decreases, thus reducing the risk of hypercalcemia in these patients. The absorption of phosphorus plays a critical role in the development of metabolic bone diseases in patients with chronic renal failure. The retention of phosphate plays a pivotal role in causing secondary hyperparathyroidism associated with osteodystrophy and soft tissue calcification. The majority of patients with advanced renal insufficiency (glomerular filtration rate less than 30 mL/min) exhibit phosphate retention with hyperphosphatemia. The rate of removal of phosphate by dietary manipulation or by dialysis is insufficient to prevent hyperphosphatemia in most dialysis patients. Dialysis patients absorb 40% to 80% of dietary phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet needs to be reduced. Phosphate binders in most renal failure patients on maintenance dialysis are effective in accomplishing that. INDICATIONS AND CLINICAL USE PhosLo (calcium acetate) is indicated for the control of hyperphosphatemia in end stage renal failure. Page 2 of 15 CONTRAINDICATIONS PhosLo (calcium acetate) is contrai Read the complete document