Calcium supplements / vitamin D3.

Calcium carbonate, vitamin D - deficiency 3

Per tablet: Calcium carbonate: 1500mg equivalent to 600mg of elemental calcium Colecalciferol: 400iu equivalent to 10?g vitamin D3

Chewable Tablet

As an adjunct to specific therapy for osteoporosis and in situations requiring therapeutic supplementation of malnutrition e.g. in pregnancy and established vitamin D dependent osteomalacia. The prevention and treatment of calcium deficiency/vitamin D deficiency especially in the housebound and institutionalised elderly subjects. Deficiency of the active moieties is indicated by raised levels of PTH, lowered 25-hydroxy vitamin D and raised alkaline phosphatase levels which are associated with increased bone loss.

Oral.

Adults and Elderly and children above 12 years of age:

2 chewable tablets per day, preferably one tablet each morning and evening.

Not recommended for children under 12 years.

Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure. Hypersensitivity to any of the tablet ingredients.

Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.

Adcal-D₃ contains a small quantity of soya oil and is therefore contraindicated in patients who are allergic to peanuts or soya.

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully including periodic checks of plasma calcium levels and urinary calcium excretion.

In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.

With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours (300mg/24 hours).

Caution is required in patients receiving treatment for cardiovascular disease.

Adcal-D₃ should also be used with caution in other patients with increased risk of hypercalcaemia e.g. patients with sarcoidosis or those suffering from malignancies.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Allowances should be made for calcium and vitamin D supplements from other sources.

The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalised patients.

Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium.

Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D.

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.

Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone or tetracycline antibiotics or iron. It is advisable to allow a minimum period of four hours before taking the calcium.

The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea. Following administration of vitamin D supplements occasional skin rash has been reported. Hypercalciuria, and in rare cases hypercalcaemia have been seen with long term treatment at high dosages.

ProStrakan

(P- Pharmacy)

04 June 2009