Each tablet contains
Calcium Citrate malate ....... 1140 mg
Magnesium hydroxide .......100 mg
Zinc sulphate...................... 4 mg
Calcium plays a critical role in the body. It is essential for normal functioning of nerves, cells, muscle and bone. Calcium prevents bone loss and is associated with a modest reduction in fracture risk. Calcium and vitamin D preparations are used to prevent or to treat calcium deficiency. A vitamin D resistant state may exist in uremic patients because of the failure of the kidney to adequately produce calcitriol.
Calcium citrate malate is a water-soluble calcium supplement. It is the calcium salt of citric acid & malic acid and is highly bioavailable. Calcium citrate malate's bioavailability stems from its water-solubility and its method of dissolution. When dissolved, it releases calcium ions and a calcium-citrate complex. Calcium ions are absorbed directly into intestinal cells, and the citrate complex enters the body through paracellular absorption.
Calcium citrate malate is approximately (4-5%) more absorbable than calcium carbonate and is well absorbed regardless of stomach acid. Studies have suggested that calcium citrate malate is better absorbed than calcium carbonate and that the citrate form might thus be more effective in helping to prevent or ameliorate osteoporosis.
Calcitriol is the active from of vitamin D3 (cholecalciferol). It is produced in the kidney from the vitamin D metabolite 25-hydroxyvitamin D3 (calcifediol). Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.
The known sites of action of calcitriol are intestine, bone, kidney and parathyroid gland. In bone, calcitriol in conjunction with parathyroid hormone stimulates resorption of calcium; and in the kidney, calcitriol increases the tubular reabsorption of calcium.
Zinc is a nutritional supplement important for normal growth and tissue repair. Urinary elimination of zinc is increased in osteoporotic women. Zinc depletion is shown to diminish the response of oral calcitriol when administered orally. Supplementary zinc not only improves calcitriol response but also helps to arrest bone loss in old postmenopausal women.
Bones with Osteoporosis have low Magnesium content. Hence, it is essential to supplement Magnesium in Osteoporosis to maintain the integrity of bones.
Management of hypocalcaemia in patients undergoing dialysis for chronic renal failure. It has been shown to significantly reduce elevated parathyroid hormone (PTH) levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy
Hypocalcaemia in hypoparathyroidism
Renal tubular osteocalcaemia
Sporadic and oncogenic hypophasphatemicosteomalacia
Osteomalacia in Malabsorption syndrome
Hypocalcaemia and hypomagnesaemia after small bowel resection
DOSAGE AND ADMINISTRATION
The optimal dose must be carefully determined for each patient. The recommended initial dose is one tablet of BONETUF daily.
BONETUF should not be given to patients with hypercalcaemia or evidence of vitamin D toxicity.
WARNINGS AND PRECAUTIONS
Since Calcitriol is the most potent metabolite of vitamin D available, vitamin D and its derivatives should be withheld during treatment. In patients undergoing dialysis, who have high serum phosphorus levels, appropriate serum phosphate binders should be used.
PREGNANCY & LACTATION
Category C. There are no adequate and well-controlled studies in pregnant women. BONETUF should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Calcitriol may be excreted in human milk. A mother should not nurse while taking BONETUF.
Adverse effects are in general similar to those encountered with excessive vitamin D intake. The early symptoms of vitamin D intoxication associated with hypercalcaemia include weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain and metallic taste. Late signs include polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolaemia, elevated SGOT and SGPT, ectopic calcification, hypertension, cardiac arrhythmias and rarely, overt psychosis.