Description
Indications of Rocal-M Tablet
Prevention and treatment of osteoporosis; as nutritional supplement; pregnancy and lactation; deficiency states of calcium and vitamin D3; as adjunct treatment to asthmatics to prevent steroid induced osteoporosis; as adjunct treatment to antiseizure
Pharmacology of Rocal-M Tablet
Diet is very important in preventing osteoporosis and other bone diseases. Calcium, magnesium and vitamin D3 are macronutrients for the bones. Without vitamin D3, very little calcium is absorbed. Like calcium, magnesium helps increase the strength and stiffness of bones. Recent epidemiological studies suggest that several micronutrients such as copper, manganese, zinc and boron play an important role in bone health. Micronutrient deficiencies are observed in patients with osteoporosis.
Dosage & Administration of Rocal-M Tablet
1 tablet twice daily, preferably 1 tablet in the morning and 1 tablet in the evening or as directed by physician. It is best taken with or just after main meals with a full glass of water.
Interaction of Rocal-M Tablet
The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypocalcaemia 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-D3 because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of Vitamin-D3. The effects of digitalis and other cardiac glycosides may be attenuated with the oral administration of calcium combined with Vitamin-D3. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium. Calcium salts may reduce the absorption of thyroxin, bisphosphonates, sodium fluoride, quinolone or tetracycline antibiotics or iron. It is advisable to allow a minimum period of four hours before taking the calcium.
Contraindications
Absolute contraindications are hypercalcaemia resulting from myeloma, bone metastasis or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and Vitamin-D3 overdosage, Severe renal failure. Hypersensitivity to any of the tablet ingredients.Relative contraindications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.
Side Effects of Rocal-M Tablet
The use of calcium supplements has rarely given rise to mild gastro-intestinal disturbances such as constipation, flatulence, nausea, gastric pain, diarrhea. Following administration of vitamin-D3 supplements occasional skin rash has been reported. Hypercalciuria and in rare cases hypercalcaemia have been seen with long term treatment at high doses.
Pregnancy & Lactation
During pregnancy and lactation treatment should always be under the direction of a physician. During pregnancy and lactation, requirements for calcium and vitamin-D3 are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If calcium and iron supplements are both required to be administered to the patient, they should be taken at different times. Overdoses of vitamin-D3 have shown teratogenic effects in pregnant animals. In humans long term hypercalcaemia can lead to physical and mental retardation, aortic stenosis and retinopathy in a new born child. Vitamin-D3 and its metabolites pass into the breast milk.
Precautions & Warnings
Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria. Urinary calcium excretion should also be measured. 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 and stop treatment temporarily if urinary calcium exceeds 7.5 mmol/24 hours. Allowances should be made for calcium and vitamin-D3 supplements from other sources.
Therapeutic Class
Specific mineral & vitamin combined preparations
Storage Conditions
Store below 250 C in a cool and dry place. Protect from light.
Pharmaceutical Name of Rocal-M Tablet
Healthcare Pharmaceuticals Ltd
Generic of Rocal-M Tablet
Calcium Carbonate + Vitamin D3 + Multimineral