Calcium-Sandoz

CALCIUM-SANDOZ®

Novartis Consumer Health

Calcium Preparations

Calcium Therapy

Indications And Clinical Uses: As a dietary supplement where calcium intake may be inadequate: childhood and adolescence, pregnancy and lactation, postmenopausal females and in the aged.

In the treatment of calcium deficiency states which may occur in diseases such as: tetany of the newborn (as a supplement to parenterally administered calcium), hypoparathyroidism (acute and chronic), pseudo-hypoparathyroidism, postmenopausal and senile osteoporosis, rickets and osteomalacia.

Contra-Indications: Hypercalcemia and hypercalciuria (e.g. hyperparathyroidism, vitamin D overdosage, decalcifying tumors such as plasmocytoma, bone metastases); severe renal disease; and in calcium loss due to immobilization. Hypersensitivity to any of the components of Calcium-Sandoz.

Although no concrete evidence is available about the metabolic process leading from calcium glucono-galacto-gluconate to galactose, it is advisable not to administer to galactosemic patients.

Precautions: For diabetic patients, consideration should be given to the sucrose content of 719 mg/tablet of Calcium-Sandoz Forte. Gramcal and Calcium-Sandoz Syrup are suitable for sodium and potassium restricted diets. Calcium-Sandoz Forte is suitable for potassium restricted diets. Because of the presence of sodium (12 mmol), Calcium-Sandoz Forte is not suitable for sodium restricted diets.

In mild hypercalciuria (exceeding 300 mg/24 hours) as well as in chronic renal failure, or where there is evidence of stone formation in the urinary tract, adequate checks must be kept on urinary calcium excretion. If necessary the dosage should be reduced or calcium therapy discontinued. In patients prone to formation of calculi in the urinary tract an increased fluid intake is recommended.

Drug Interactions: Administration of corticosteroids may interfere with calcium absorption.

Calcium-Sandoz syrup and effervescent tablets should not be taken within 3 hours of oral tetracycline or fluoride administration (possible interference of absorption).

High vitamin D intake should be avoided during calcium therapy unless especially indicated.

Thiazide diuretics cause calcium retention and this may exacerbate hypercalcemia from CaCo3 (calcium carbonate).

Administration of calcium may reduce the response to verapamil and possibly other calcium channel blockers.

Given in large doses to digitalized patients, calcium may increase the risk of cardiac arrhythmias.

Certain dietary substances interfere with the absorption of calcium. These include oxalic acid (found in large quantities in rhubarb and spinach), phytic acid (bran and whole cereals) and phosphorus (milk and other dairy products).

Adverse Reactions: Occasional diarrhea or constipation may occur with high calcium intake.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Acute overdosage has not been reported. It would be expected to cause gastrointestinal disturbances but not to result in hypercalcemia, except in patients treated with an excessive dose of vitamin D.

Dosage And Administration: Calcium-Sandoz Forte: Children: completely dissolve 1 to 2 tablets in a glass of water daily. Adults: completely dissolve 1 to 2 tablets in a glass of water twice a day or as directed by the physician. Sugar can be added to taste or tablets can be dissolved in fruit juice.

Calcium-Sandoz Gramcal: Usual dose in osteoporosis, 1 or 2 tablets (dissolved in water) daily, or as prescribed.

Calcium-Sandoz Syrup: Infants: 0 to 3 years: 10 mL given 1 to 3 times daily. Children: 4 to 12 years: 15 mL given 1 to 3 times daily. Adults: 20 mL given 1 to 3 times daily. Pregnancy and nursing: 20 mL given 1 to 3 times daily.

Availability And Storage: Calcium-Sandoz Forte: Each whitish, effervescent tablet contains: calcium lactate-gluconate 2 940 mg, calcium carbonate 300 mg and provides 500 mg (12.5 mmol) elemental calcium. Nonmedicinal ingredients: calcium cyclamate, citric acid, flavor, polyethylene glycol, sodium hydrogen carbonate and sucrose. Energy: 74.5 kJ (18 kcal). Sodium: 12 mmol (274 mg). Tubes of 20. Protect from heat and humidity.

Calcium-Sandoz Gramcal: Each whitish, effervescent tablet contains: calcium lactate-gluconate 2 327 mg, calcium carbonate 1 750 mg and provides 1 000 mg (25 mmol) of elemental calcium. Nonmedicinal ingredients: aspartame, citric acid, flavor and polyethylene glycol. Energy: 59.3 kJ (14.17 kcal). Potassium: 10 mEq. Sodium: 0.07 mmol (1.69 mg). Tubes of 20. Protect from heat and humidity.

Syrup: Each 5 mL of maize colored syrup contains: calcium lactobionate 295.0 mg, calcium glubionate 1 437.5 mg, elemental sodium: 0.007 mmol (0.162 mg) and provides 2.7 mmol (110 mg) elemental calcium. Nonmedicinal ingredients: benzoic acid, citric acid, flavors, malic acid, sodium saccharin, sorbitol and water. Energy: 28.4 kJ (6.77 kcal)/5 mL. Bottles of 230 mL. (Shown in Product Recognition Section)

CALCIUM-SANDOZ® Novartis Consumer Health Calcium Preparations Calcium Therapy

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