Calsto D®500
Calcium Carbonate + Vitamin D

COMPOSITION:
Calsto D® tablet: Each tablet contains Calcium Carbonate USP 1250mg equivalent to 500mg elemental Calcium, Vitamin-D 200I.U.as Cholecalciferol USP.

PHARMACOLOGICAL INFORMATION:
Pharmacological Action
Calcium is used as a pharmacological agent in humans almost entirely to remedy deficiency. Adequate calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a 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 also essential for healthy bones as it aids in calcium absorption from the GI tract. In addition to this it stimulates bone formation. Clinical studies show that calcium and vitamin-D has synergistic effects on bone growth as well as in Osteoporosis and fracture prevention.

Mechanism of Action
Calsto D ® (Calcium with Vitamin D3) supports optimal calcium absorption and bone mineral composition, in addition of promoting potential cardiovascular and colon health. Several clinical trials reveal the positive effects of combined supplemental calcium and vitamin D for bone health. Vitamin D is important for its ability to promote intestinal calcium and phosphorous absorption, reduce urinary calcium loss and enhance healthy bone composition. Supplementation with calcium and vitamin D daily for one and a half years supported bone composition of the femur. Calcium and vitamin D supplementation promoted calcium utilization and maintained healthy bones in postmenopausal women. Vitamin D may also provide cardiovascular support for some individuals, which may be attributed to its effect on calcium metabolism or possibly by helping to maintain healthy plasma renin function. Additionally, calcium has been associated with supporting distal colon health. A role for vitamin D in supporting colon health by promoting healthy cellular function has also been suggested. Preliminary evidence suggests that vitamin D may also support healthy glucose metabolism, since vitamin D receptors are present on the islet cells of the pancreas.

CLINICAL INFORMATION:
Therapeutic Indication
Calcium and Vitamin-D is used for the treatment of osteoporosis, osteomalacia, rickets, tetany, and parathyroid disease. Also used in raised calcium requirement for children and adolescents at times of rapid growth, inadequate intake of calcium in the diet due to malnutrition, prevention and treatment of osteoporosis, disorders of osteogenesis and tooth formation (in addition to specific treatment),latent tetany and during pregnancy and lactation. It is also used as routine supplement and phosphate binder in chronic renal failure.

Use in children
Not recommended.

Dosage & Administration
Two tablets daily or one tablet twice daily. It is best taken with or just after a meal to improve absorption. Each dose should be taken with a full glass of water.

Contraindication
Absolute contraindications are hypercalcaemia, primary hyperparathyroidism, kidney stone, severe renal failure, Calcium & Vitamin D overdose, hypersensitivity to any of the tablet ingredients.

Use in patients with impaired renal function
Patients with mild to moderate renal failure or mild hypercalcuria 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 hypercalcuria. In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalcuria. 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 7.5 mmol/24 hours. Allowances should be made for calcium and vitamin-D supplements from other sources.

Drug Interaction
It has possible interaction with digoxin, antacids containing calcium, aluminum or magnesium, other calcium supplements, calcitriol or other vitamin-D supplements; tetracycline, Doxycycline, amino cycline or oxytetracycline etc. So before taking any of these drugs consultations of the physicians are needed.

Use in Pregnancy & Lactation
It should be used as directed by the physician during pregnancy and lactation.

Undesirable Effects
Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure. Also there may be allergic reactions, irregular heartbeats, nausea, vomiting, decreased appetite dry mouth and drowsiness. Following administration of vitamin-D supplements occasion skin rash has been reported.

PHARMACEUTICAL INFORMATIONS
Storage Conditions
Store in a cool (below 30C) and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Calsto D® tablet: Each commercial box contains 30 tablet in HDPE container.