CALCIDOSE

Calcium carbonate is an inorganic salt used as an antacid.

It is a basic compound that acts by neutralizing hydrochloric acid in gastric secretions.

Subsequent increases in pH may inhibit the action of pepsin.

An increase in bicarbonate ions and prostaglandins may also confer cytoprotective effects.

Calcium carbonate may also be used as a nutritional supplement or to treat hypocalcemia.

For relief of heartburn and acid indigestion.

May also be used as a nutritional supplement or to treat hypocalcemia.

Gastric-peptic disease occurs as a result of an imbalance between protective factors, such as mucus, bicarbonate, and prostaglandin secretion, and aggressive factors, such as hydrochloric acid, pepsin, and Helicobacter pylori ( H. pylori ).

Antacids work by restoring acid-base balance, attenuating the pepsin activity and increasing bicarbonate and prostaglandin secretion.

The acid-neutralizing capacity of calcium carbonate is 58 mEq/15 ml. When used as a nutritional supplement, calcium carbonate acts by directly increasing calcium stores within the body.

Calcium carbonate is a basic inorganic salt that acts by neutralizing hydrochloric acid in gastric secretions.

It also inhibits the action of pepsin by increasing the pH and via adsorption.

Cytoprotective effects may occur through increases in bicarbonate ion (HCO 3 - ) and prostaglandins.

Neutralization of hydrochloric acid results in the formation of calcium chloride, carbon dioxide and water.

Approximately 90% of calcium chloride is converted to insoluble calcium salts (e.g. calcium carbonate and calcium phosphate).

Maximal absorption occurs at doses of 500 mg or less taken with food.

Oral bioavailability depends on intestinal pH, the presence of food and dosage.

Calcium is rapidly distributed taken up by skeletal tissues following absorption and distribution into extracellular fluids.

Bone contains 99% of the body's calcium and the remaining 1% is approximately equally distributed between intracellular and extracellular fluids.

Excreted mainly in the feces.

The majority of renally filtered calcium is reabsorbed in the ascending limb of the loop of Henle and the proximal and distal convoluted tubules.

Also secreted by sweat glands.

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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.