ELIPHOS calcium acetate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)

Available from:

KAISER FOUNDATION HOSPITALS

INN (International Name):

CALCIUM ACETATE

Composition:

CALCIUM ACETATE 667 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ELIPHOS- CALCIUM ACETATE TABLET
KAISER FOUNDATION HOSPITALS
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DESCRIPTION
Each white, round tablet (stamped “CYP910”) 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
NF; sodium lauryl sulfate, NF; and crospovidone, NF. ELIPHOS (Calcium
Acetate, 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 (ELIPHOS ) 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.
ELIPHOS 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 f