Calcium Lactate Kozakai M

1) Indicated for the treatment of calcium deficiency states as a therapeutic supplement in pregnancy, lactation, osteoporosis, post-gastrectomy malabsorption, osteomalacia and rickets.

Calcium Lactate Kozakai M Tablets BP should not be taken for long periods without medical advice.

Adults including elderly: 1-2 tablets (300-600mg) daily.

Pregnant women: (During the third trimester and also during lactation) 3-4 tablets (0.9-1.2g) daily.

Children over 3 years: One tablet (300mg) daily.

For oral administration.

Severe hypercalcaemia and hypercalciuria (eg hypervitaminosis D, hyperparathyroidism, severe renal failure, osteoporosis due to immobility and decalcifying tumours such as plasmocytoma and skeletal metastases). Patients receiving therapy with cardiac glycosides such as digoxin must not be given calcium supplements.

Careful monitoring of blood levels and urinary calcium excretion is necessary, particularly when high dose calcium therapy has been used, especially in children.

Treatment should be suspended if calcium blood levels exceed 2.625-2.75mmol/litre (105-110mg/litre) or if urinary calcium excretion exceeds 5mg/kg.

Calcium salts should be administered with care to infants with hypokalaemia, as elevation of serum calcium levels may further reduce serum potassium levels.

Calcium salts should be administered with caution to patients with impaired renal function, cardiac disease, or sarcoidosis.

None known.

Calcium salts may cause constipation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

The symptoms of overdosage with calcium include anorexia, lassitude, nausea, vomiting, headache, extreme thirst, vertigo, and raised blood urea; calcium may be deposited in many tissues including the kidney and arteries and the plasma cholesterol level may become elevated. Cardiac arrhythmias and bradycardia may also occur.

Calcium intake should be reduced to a minimum and any dehydration and electrolyte imbalance corrected immediately. Severe hypercalcaemia should be treated with an iv infusion of sodium chloride 0.9%; a loop diuretic may be given to increase urinary calcium excretion. If this fails, calcitonin may be administered by injection, or alternative, biphosphonates, plicamycin or corticosteroids may be used. Phosphate infusion must not be given due to the danger of metastatic calcification. In severe cases, significant amounts of calcium may be removed by peritoneal dialysis.

Patients with symptoms of overdosage should avoid exposure to direct sunlight.

Special care must be exercised when treating overdosage in patients with impaired renal or hepatic function.

Calcium Lactate Kozakai M is used in calcium deficiency.

Calcium is absorbed from the small intestine; about one third of ingested calcium is absorbed. Absorption decreases with age and may be more efficient when the body is deficient in calcium or from diets deficient in calcium. It is excreted in sweat, bile, pancreatic juice, saliva, urine, faeces and milk.

Not applicable

None known.

Not applicable.