COMPOSITION: Each Bone-Cal Tablet contains:

• Active ingredient: Oyster Shell (37% Ca) 1350 mg Eq. to 500 mg Calcium (Ca++).
• Inactive ingredients: Croscarmellose Sodium, Silicified Microcrystalline cellulose (Prosolv 90 HD), Colloidal anhydrous silica (Aerosil 200), Sodium stearyl fumarate, Opadry II Green.

PHARMACEUTICAL FORM: Film coated tablet.

CLINICAL PARTICULARS

Therapeutic Indications

• A supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are increased.
• A phosphate binder for the control of plasma levels of organic phosphate (Pi) in hemodialysis and CAPD (Continuous Ambulatory Peritoneal Dialysis) patients.

Posology and Method of Administration

As a supplemental source of calcium:

• Adults and the elderly: 1 tablet 2 or 3 times a day.
• Children (over 12 years): 1 tablet 2 or 3 times a day.

As a phosphate binder: Initially 1 tablet 3 times a day. The dose is gradually adjusted until Pi is controlled (it is assumed that the regular monitoring of hemodialysis and CAPD patients includes Pi and plasma calcium).

Contra-Indications

• The product should not be given to patients receiving digitalis glycosides because the toxic effects are increased by calcium.
• It should not be given in cases of hypercalcemia, hypercalciuria or hyperparathyroidism and only given with caution in patients with impaired renal function or to those with a history of renal stones.
• Calcium carbonate should not he used in or during the treatment of zollinger-Ellison Syndrome.

Special Warnings and Special Precautions for Use

• High dosage of the product may cause acid rebound.
• Regular monitoring of plasma levels of inorganic phosphate (Pi) and plasma calcium are necessary if the product is to be effectively used as a phosphate binder, and hypercalcemia or phosphate depletion syndrome are to be avoided.
• In a proportion of patients, prolonged high dosage particularly in conjunction with high calcium containing foods may result in hypercalcemia.
• The dosage of Bone-Cal should be reduced or if necessary withdrawn if hypercalcemia occurs.

Interactions with other Medications

• Digitalis glycosides: Toxic effects are increased by calcium.
• Vitamin D: In chronic renal failure modification of Vitamin D therapy may be required to avoid hypocalcemia When calcium carbonate is used as a phosphate binder.
• Ciproflexacin: Concurrent use of calcium carbonate reduces the total absorption and peak serum levels of ciprofloxacin.
• Bran: Decreases the gastrointestinal absorption of calcium and therefore reduces the efficacy of calcium supplements.
• Thiazide Diuretics: Thiazide diuretics may increase the risk hypercalcemia.
• Calcium salts reduce the absorption of a number of other drugs such as bisphosphonates, fluoride, some fluoroquinolones and tetracyclines. Administration should be separated by at least 3 hours.

Pregnancy and Lactation

As with all drugs during pregnancy, care should be taken in assessing the potential risk to benefit ratio.

Effects on Ability to Drive and Use Machines

None stated.

Undesirable Effects

The product may cause constipation, flatulence and eructation. If larger doses than those quoted previously are taken acid rebound may occur.

Overdose

The symptoms are usually, headache, nausea, nocturia, irritability and weakness. Plasma levels of calcium are raised and there may be mild alkalosis. Plasma levels usually revert to normal soon after withdrawal of calcium containing foods.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic Properties

Calcium is the fifth most abundant element found in the body and plays important physiological roles, this includes nerve, muscle and cardiac function, the maintenance of membranes and coagulation of the blood.

Pharmacokinetic Properties

Above ⅓ ( one third) of ingested calcium is absorbed. Only the ionized form is absorbed. About 90% of the bodies calcium is contained in the skeleton. The plasma contains about 5 meq/L. Calcium is secreted in the gastric juicies, saliva, bile and sweet. Excretion by the kidney depends upon the degree of reabsorption. This is stimulated by parathyroid hormone and the active metabolites of vitamin D.

Pre—clinical Safety Data

None of relevance.

PHARMACEUTICAL PARTICULARS

• Incompatibilities: None stated .
• Shelf-Life: 3 years.
• Special Precautions for Storage: Store at temperature not exceeding 30 °C, In dry place.
• How Supplied: Carton Box containing 1,2,3 Al/ Colorless transparent PVC) strips each of 10 film coated tablets + insert leaflet.
• Keep all medicaments out of reach of children.
• Bone-Cal is a product of: AMOUN PHARMACEUTICAL CO. EI-Obour City, Cairo, Egypt. SAE.

Bone-Cal – Information Leaflet