CALCIFOR

Calcium acetate acts as a phosphate binder.

Its chemical name is calcium acetate.

Its molecular formula is

C 4 H 6 CaO 4, and its molecular weight is 158.17.

Its structural formula is

Each capsule is of size ‘00el’ hard gelatin capsule shell with blue opaque cap and white opaque body imprinted with “667 mg” on cap and “IG 377” on body in black ink filled with white to off white powder.

Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.

Each capsule contains the following inactive ingredients: Sodium Lauryl Sulfate and Sodium Stearyl Fumarate.

The gelatin cap and body have the following inactive ingredients: FD&C blue #1, FD&C red #3, titanium dioxide, USP, gelatin, USP and iron oxide black.

Calcium acetate capsules, USP are administered orally for the control of hyperphosphatemia in end stage renal failure. “the drug product meets USP Dissolution Test 4” calcium acetate Chemical structure.

Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.

Patients with

ESRD retain phosphorus and can develop hyperphosphatemia.

High serum phosphorus can precipitate serum calcium resulting in ectopic calcification.

Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD. 12.1 Mechanism of Action Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration. 12.2 Pharmacodynamics Orally administered calcium acetate from pharmaceutical dosage forms is 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.

Hypercalcemia is discussed elsewhere.

The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting.

In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy.

To report SUSPECTED ADVERSE

REACTIONS, contact Cipla Ltd.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical studies, calcium acetate has been generally well tolerated.

Calcium acetate was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of calcium acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients.

Adverse reactions (>2% on treatment) from these trials are presented in Table 1.

Table 1: Adverse Reactions in Patients with End-Stage Renal Disease Undergoing Hemodialysis Preferred Term Total adverse reactions reported for calcium acetate n=167 n (%) 3-month, open-label study of calcium acetate n=98 n (%) Double blind, placebo-controlled, cross-over study of liquid calcium acetate n=69 Calcium acetate n (%) Placebo n (%) Nausea 6 6 0 0 Vomiting 4 4 0 0 Hypercalcemia 21 16 5 0 Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting.

More severe hypercalcemia is associated with confusion, delirium, stupor, and coma.

Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate.

• induced hypercalcemia.

Isolated cases of pruritus have been reported, which may represent allergic reactions. 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.

The following additional adverse reactions have been identified during post-approval of calcium acetate: dizziness, edema, and weakness.

Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia.

Patients with hypercalcemia.

The recommended initial dose of calcium acetate for the adult dialysis patient is 2 capsules with each meal.

Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop.

Most patients require 3-4 capsules with each meal.

Starting dose is 2 capsules with each meal.

Titrate the dose every 2-3 weeks until acceptable serum phosphorus level is reached.

Each capsule is of size ‘00el’ hard gelatin capsule shell with blue opaque cap and white opaque body imprinted with “667 mg” on cap and “IG 377” on body in black ink filled with white to off white powder.

Supplied in

Bottles of 60 (NDC 69097-862-03) and 200 (NDC 69097-862-83).

Store at 20° to 25°C (68° to 77°F) .

Calcium acetate capsules contain calcium acetate.

Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women.

Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment.

Maintenance of normal serum calcium levels is important for maternal and fetal well being.

Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism.

Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.

A calcium acetate capsule contains calcium acetate and is excreted in human milk.

Human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.

Safety and effectiveness in pediatric patients have not been established.

Clinical studies of calcium acetate did not include sufficient numbers of subjects aged and over to determine whether they respond differently from younger subjects.

Other clinical experience has not identified differences in responses between elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.