Remophos667 mg

Remophos 667 mg is indicated for the control of hyperphosphatemia in end stage renal disease (ESRD) and does not promote aluminum absorption.

Drugs for reduction of serum phosphorus in patients with ESRD, Minerals in bone formation, Specific mineral preparations

Remophos 667 mg 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. Remophos 667 mg is highly soluble at neutral pH, making the Calcium readily available for binding to phosphate in the proximal small intestine. Orally administered Remophos 667 mg 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.

Adult: Initially 3-4 g daily. Usual range: 6-12 g daily. To control hyperphosphataemia in chronic renal failure: Initially 1.334 g (338 mg of calcium). May increase dosage gradually according to serum phosphate conc, provided hypercalcaemia does not occur.

The recommended initial dose of Remophos 667 mg for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum phosphate level below 6 mg/dl, as long as hypercalcemia does not develop. Most patients require 3-4 tablets with each meal.Pediatric Use: The safety and efficacy of Remophos 667 mg have not been established.Geriatric Use: In clinical studies, no overall differences in safety or effectiveness were observed between the geriatric and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Remophos 667 mg may decrease the bioavailability of tetracycline.

Remophos 667 mg is contraindicated in patients with hypercalcemia.

Patients may occasionally experience nausea during Remophos 667 mg therapy. Hypercalcemia may occur during treatment with Remophos 667 mg. Mild hypercalcemia (Ca >10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca >12 mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the Remophos 667 mg dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Remophos 667 mg therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of Remophos 667 mg induced hypercalcemia. The long-term effect of Remophos 667 mg 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 Remophos 667 mg. It is not known whether Remophos 667 mg can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Remophos 667 mg 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.

Excessive dosage of Remophos 667 mg induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. Remophos 667 mg should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. Remophos 667 mg therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. The patient should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia.

Administration of Remophos 667 mg in excess of the appropriate daily dosage can cause severe hypercalcemia.

Store at 15o C to 30o C in a dry place protected from light. Keep out of reach of children.

Remophos 667 mg 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. Remophos 667 mg is highly soluble at neutral pH, making the Calcium readily available for binding to phosphate in the proximal small intestine. Orally administered Remophos 667 mg 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.

Teratogenic Effects: Category C. Animal reproduction studies have not been conducted with Remophos 667 mg. It is also not known whether Remophos 667 mg can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Remophos 667 mg should be given to a pregnant woman only if clearly needed.