Remophos? is indicated for the - o Treatment of hyperphosphatemia o Control of hyperphosphatemia in end stage renal failure
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 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 fasting conditions and up to approximately 30% under non fasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
The recommended initial dose of Remophos? for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum phosphate value below 6mg/dl,as long as hypercalcemia does not develop. Most patients require 3-4 tablets with each meal.
Calcium Acetate may decrease the bioavailability of tetracycline.
Calcium Acetate is contraindicated in patients with hypercalcemia.
In clinical studies,patients have occasionally experienced nausea during Calcium Acetate therapy. Hypercalcemia may occur during treatment with Calcium Acetate. Mild hypercalcemia (Ca> 10.5mg/dl) may be asymptomatic or manifest itself as constipation, anorexia,nausea and vomiting. More severe hypercalcemia (Ca>12mg/dl) is associated with confusion,delirium,stupor and coma. The long-term effect of Calcium Acetate on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.
Animal reproduction studies have not been conducted with Calcium Acetate. It is not known whether Calcium Acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium Acetate should be given to a pregnant woman only if clearly needed. There are no adequate studies in women for determining infant risk when using the medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Administration of Calcium Acetate in excess of the appropriate daily dosage can cause severe hypercalcemia.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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