Calcium Carbonate [Coral source] , Vitamin D3
Dosage Form: Tablet.
This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.
This medication is used to treat and prevent osteoporosis, osteomalacia, tetany, hypoparathyroidism, and osteogenesis disorders. Also used as a supplement for calcium deficiency in children’s diets, rickets, pregnancy and breastfeeding, and geriatric people. Pancreatitis, phosphate binder in chronic renal failure, and other conditions are among the other indications.
One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.
Route of administration: Orally.
Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics. Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of calcium tablet. Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D. Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before, or four to six hours after, oral intake of calcium. Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels. If a bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of calcium tablet since gastrointestinal absorption may be reduced. Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble calcium salts. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.
Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.
Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.
Pregnancy & Lactation:
During pregnancy the daily intake should not exceed 1500 mg calcium and 600 IU cholecalciferol (15 mcg vitamin D). Studies in animals have shown reproductive toxicity with high dose of vitamin D. In pregnant women, overdoses of calcium and vitamin D should be avoided as permanent hypercalcaemia has been related to adverse effects on the developing foetus. There are no indications that vitamin D at therapeutic doses is teratogenic in humans. Elemental Calcium & Vitamin D3 tablet can be used during pregnancy, in case of a calcium and vitamin D deficiency. Elemental Calcium & Vitamin D3 tablet can be used during breast-feeding. Calcium and vitamin D3 pass into breast milk. This should be considered when giving additional vitamin D to the child.
Precautions & Warnings:
During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurement of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function, the dose should be reduced or the treatment discontinued. Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not metabolised normally and other forms of vitamin D should be used. Elemental Calcium & Vitamin D3 tablet should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active metabolite. In these patients, serum calcium levels and urinary calcium excretion must be monitored. Elemental Calcium & Vitamin D3 tablet should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia. The dose of vitamin D in Elemental Calcium & Vitamin D3 tablet should be considered when prescribing other drugs containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.
Specific mineral & vitamin combined preparations
Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
Manufactured by: Orion Pharma Ltd.