Khriz Care-Calcium Carbonate

See table.

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Each uncoated tablet contains: Calcium Carbonate BP 1250 mg equivalent to Elemental Calcium 500 mg, Excipients q.s.
Ingredients: Calcium carbonate, Mannitol, Sucrose, Purified water, Pregelatinized starch, Saccharin sodium, Peppermint flavor, Magnesium stearate.

Pharmacology: Pharmacokinetics: Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.
Distribution and biotransformation: 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.
Excretion and elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

Chewable Calcium Carbonate Tablets BP 500 mg are to be chewed asa supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high.
Chewable Calcium Carbonate Tablets BP 500 mg may be used as an adjunct to conventional therapy in the prevention and treatment of osteoporosis. They may be used as a phosphate binding agent in the management of renal failure in patients on renal dialysis.

Posology: For oral administration: Adults: Adjunctive therapy in osteoporosis 2 to 3 tablets daily.
Prevention and treatment of calcium deficiency 2 to 3 tablets daily.
Phosphate binder: Dose as required by the individual patient depending on serum phosphate level.
Special patient populations: Elderly patients: Dosage as for adults.
Paediatric patients: Prevention and treatment of calcium deficiency 2 to 3 tablets daily.
Phosphate Binder: Dose as required by the individual patient depending on serum phosphate level.
Impaired renal function: In patients with severe renal failure having a creatinine clearance of less than 30 ml/minute, dosage adjustments may be necessary dependent on serum calcium levels.
Impaired hepatic function: No dose adjustment is required.

Hypersensitivity to the active substance or to any of the excipients.
Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria, for example in hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmacytoma and skeletal metastases, in severe renal failure untreated by renal dialysis and in osteoporosis due to immobilisation.
Renal calculi (nephrolithiasis).

In renal insufficiency the tablets should be given only under controlled conditions for hyperphosphataemia. Caution should be exercised in patients with a history of renal calculi.
During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in patients on concomitant treatment with cardiac glycosides or diuretics, in patients with a high tendency to calculus formation, in cases of hypercalcaemia, or signs of impaired renal function.
Calcium carbonate should be used with caution in patients with hypercalcaemia or signs of impaired renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account.
During high dose therapy and especially during concomitant treatment with vitamin D and/or medications or nutrients (such as milk) containing calcium, there is a risk of hypercalcaemia and milk-alkali syndrome (hypercalcaemia, alkalosis and renal impairment) with subsequent kidney function impairment. In these patients, serum calcium levels should be followed and renal function should be monitored.

Pregnancy: Chewable Calcium Carbonate Tablets BP 500 mg can be used during pregnancy. Daily intake should not exceed 2500 mg of calcium as permanent hypercalcaemia has been related to adverse effects on the developing foetus.
Breastfeeding: Calcium carbonate can be used during breast-feeding. Calcium passes into breast milk but at therapeutic doses no effects on the breastfed new-born are anticipated.

Adverse reactions are listed as follows, by system organ class and frequency. Frequencies are defined as: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) or very rare (≤1/10,000).
Metabolism and nutrition disorders: Uncommon: Hypercalcaemia and hypercalciuria.
Very rare: Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment). Seen usually only in overdose.
Gastrointestinal disorders: Rare: Constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhoea.
Skin and subcutaneous disorders: Very rare: Pruritus, rash and urticaria.

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.
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. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.
If a bisphosphonate is used concomitantly, this preparation should be administered at least three hours before the intake of Chewable Calcium Carbonate Tablets BP 500 mg since gastrointestinal absorption may be reduced.
The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine absorption. Administration of calcium and levothyroxine should be separated by at least four hours.
The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or after intake of calcium.
Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium ranelate preparations should be taken two hours before or after calcium carbonate.

Store at temperatures not exceeding 30°C.
Protect from light and moisture.

Calcium/with Vitamins

A12AA04 - calcium carbonate ; Belongs to the class of calcium-containing preparations. Used as dietary supplements.