Each opaque gelcap with a blue cap and white body is spin printed in blue and white ink with “PhosLo” printed on the cap and “667 mg” printed on the body.  Each gelcap contains 667 mg Calcium acetate (Calcium gluceptate) , USP (anhydrous; CaCHCOO); MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and 10 mg of the inert binder, polyethylene glycol 8000 NF.  The gelatin cap and body have the following inactive ingredients:  FD&C blue#1, D&C red#28, titanium dioxide, USP and gelatin, USP.

Calcium acetate (Calcium gluceptate) gelcaps are administered orally for the control of hyperphosphatemia in end stage renal failure.

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 in 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 (Calcium gluceptate) 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 (Calcium gluceptate) is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine.

Orally administered Calcium acetate (Calcium gluceptate) from pharmaceutical dosage forms has been demonstrated to be systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions.  This range represents data from both healthy subjects and renal dialysis patients under various conditions.

Calcium acetate (Calcium gluceptate) gelcaps are indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption.

Patients with hypercalcemia.

Patients with end stage renal failure may develop hypercalcemia when given calcium with meals.  No other calcium supplements should be given concurrently with Calcium acetate (Calcium gluceptate) .

Progressive hypercalcemia due to overdose of Calcium acetate (Calcium gluceptate) may be severe as to require emergency measures.  Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification.  The serum calcium level should be monitored twice weekly during the early dose adjustment period.    Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft tissue calcification.

In clinical studies, patients have occasionally experienced nausea during Calcium acetate (Calcium gluceptate) therapy.  Hypercalcemia may occur during treatment with Calcium acetate (Calcium gluceptate) .  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.  Mild hypercalcemia is easily controlled by reducing the Calcium acetate (Calcium gluceptate) dose or temporarily discontinuing therapy.  Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Calcium acetate (Calcium gluceptate) therapy.  Decreasing dialysate calcium concentration could reduce the incidence and severity of Calcium acetate (Calcium gluceptate) induced hypercalcemia.  The long-term effect of Calcium acetate (Calcium gluceptate) on the progression of vascular of soft tissue calcification has not been determined.

Isolated cases of pruritus have been reported which may represent allergic reactions.

Administration of Calcium acetate (Calcium gluceptate) in excess of the appropriate daily dosage can cause severe hypercalcemia (see Adverse Reactions section).

The recommended initial dose of Calcium acetate (Calcium gluceptate) for the adult dialysis patient is 2 gelcaps with each meal.  The dosage may be increased gradually to bring the serum phosphate value below 6 mg/dl, as long as hypercalcemia does not develop.  Most patients require 3-4 gelcaps with each meal.

Gelcap:  A white and blue gelcap for oral administration containing 667 mg Calcium acetate (Calcium gluceptate) (anhydrous Ca(CHCOO); MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.

Bottles of 200

NDC 0781-2672-02