CoralCal-DX

Indications

CoralCal-DX tablet is indicated for the treatment and prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism and disorders of osteogenesis. It is also used as a supplement in case of inadequate intake of calcium in childhood diet, rickets, pregnancy and lactation, and in elderly patients. Other indications include use in pancreatitis and as a phosphate binder in chronic renal failure, as advised by a registered physician.

Pharmacology

Calcium is essential for many bodily functions and the body does not tolerate calcium deficiency even for short periods. Clinical evidence suggests that calcium is useful for the prevention and treatment of osteoporosis and associated fractures. Vitamin D is essential for healthy bones because it aids in calcium absorption from the gastrointestinal tract and stimulates bone formation. Clinical studies show that calcium and vitamin D have synergistic effects on bone growth, osteoporosis management and fracture prevention. In this preparation, calcium carbonate is sourced from coral origin and this coral calcium has a chemical structure that is similar to the composition of human bone, which may support better absorption compared to some other sources. Vitamin D3 aids in the absorption of calcium from the gastrointestinal tract and helps to maintain calcium balance in the body.

Dosage & Administration

• Adults: One tablet once or twice daily with plenty of water, preferably after food, or as directed by the physician.
• Effervescent tablet: Dissolve one effervescent tablet in a glass of water, stir and drink orally, preferably after food, or as directed by the physician.
• Children: Use and dose should be as directed by the physician based on age and clinical condition.

Interaction

Thiazide diuretics reduce urinary excretion of calcium, so there is an increased risk of hypercalcaemia and serum calcium should be regularly monitored if used together. Systemic corticosteroids reduce calcium absorption and dose adjustment of calcium may be needed. Ion exchange resins such as cholestyramine or laxatives such as liquid paraffin may reduce gastrointestinal absorption of vitamin D. Calcium carbonate may interfere with the absorption of tetracycline preparations, so these should be taken at least two hours before or four to six hours after calcium. Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D, therefore ECG and serum calcium levels should be monitored. If a bisphosphonate or sodium fluoride is used concomitantly, CoralCal-DX should be taken at least three hours before these medicines. Oxalic acid containing foods such as spinach and rhubarb and phytic acid containing foods such as whole cereals may inhibit calcium absorption by forming insoluble calcium salts, so calcium products should not be taken within two hours of such foods.

Contraindications

CoralCal-DX is contraindicated in patients with hypercalcaemia and hyperparathyroidism, hypercalciuria and nephrolithiasis, hypersensitivity to any component of the preparation, severe renal insufficiency and in patients receiving digoxin therapy without careful monitoring of serum calcium level.

Side Effects

Orally administered calcium carbonate may irritate the gastrointestinal tract and may cause constipation. Hypercalcaemia is rarely produced by calcium alone but may occur when large doses are given to patients with chronic renal failure. Allergic reactions, irregular heartbeats, nausea, vomiting, decreased appetite, dry mouth and drowsiness may occur. Following administration of vitamin D supplements, occasional skin rash has been reported.

Pregnancy & Lactation

During pregnancy the daily intake should not exceed 1500 mg calcium and 600 IU cholecalciferol, which is 15 micrograms of vitamin D. Animal studies have shown reproductive toxicity with high doses of vitamin D. In pregnant women, overdoses of calcium and vitamin D should be avoided because permanent hypercalcaemia has been associated with adverse effects on the developing fetus. There are no indications that vitamin D at therapeutic doses is teratogenic in humans. Elemental calcium and vitamin D3 tablets can be used during pregnancy in case of documented calcium and vitamin D deficiency. Elemental calcium and vitamin D3 tablets can be used during breast feeding, since calcium and vitamin D3 pass into breast milk and this should be considered when giving additional vitamin D to the child.

Precautions & Warnings

During long term treatment, serum calcium levels and renal function should be monitored, for example by measuring 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 treatment discontinued. Vitamin D should be used with caution in patients with renal impairment and calcium and phosphate levels should be monitored, taking into account the risk of soft tissue calcification. In severe renal insufficiency, vitamin D in the form of cholecalciferol is not metabolised normally and other forms of vitamin D may be required. Elemental calcium and vitamin D3 tablets should be prescribed with caution in patients with sarcoidosis because of the risk of increased metabolism of vitamin D to its active metabolite, and serum calcium and urinary calcium excretion should be monitored. The preparation should be used with caution in immobilised patients with osteoporosis because of increased risk of hypercalcaemia. The vitamin D dose in this preparation should be considered when prescribing other drugs containing vitamin D and additional calcium or vitamin D should be taken only under close medical supervision, with frequent monitoring of serum calcium and urinary calcium excretion.

Overdose Effects

Overdose may lead to hypervitaminosis D and hypercalcaemia. Symptoms of hypercalcaemia may include loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, increased thirst and urination, bone pain, nephrocalcinosis, nephrolithiasis and, in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may cause irreversible renal damage and soft tissue calcification. Treatment of hypercalcaemia includes stopping calcium and vitamin D and stopping thiazide diuretics, lithium, vitamin A and cardiac glycosides if used. Stomach emptying may be needed in patients with impaired consciousness. Management includes rehydration and, according to severity, treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids, with close monitoring of serum electrolytes, renal function, urine output and, in severe cases, ECG and central venous pressure.

Storage Conditions

Store below 30°C, protected from light and moisture, and keep out of the reach of children.