Calcitriol & Calcium combination is indicated for Osteoporosis, Hypoparathyroidism, Hypocalcaemia, Osteomalacia rickets, Renal osteodystrophy.
Specific mineral & vitamin combined preparations
Calcium plays a very important role in the body. It is necessary for normal functioning of nerves, cells, muscle, and bone. If there is not enough calcium in the blood, then the body will take calcium from bones, thereby weakening bones. Having the right amount of calcium is important for building and keeping strong bones. Calcium citrate is well absorbed on an empty stomach and does not constipate. Calcium citrate is less dependent on stomach acid for absorption.
Calcitriol is the most active known form of vitamin D 3 in stimulating intestinal calcium transport. It is normally formed in the kidneys from its immediate precursor, 25-hydroxycholecalciferol. In physiological amounts it augments the intestinal absorption of calcium and phosphate and plays a significant part in the regulation of bone mineralization. The defective production of calcitriol in chronic renal failure contributes to the abnormalities of mineral metabolism found in that disorder.
The biological effects of calcitriol are mediated by the vitamin D receptor, a nuclear hormone receptor expressed in most cell types and functioning as a ligand-activated transcription factor that binds to DNA sites to modify the expression of target genes. Oral administration of Calcitriol to patients with chronic renal failure compensates for impaired endogenous production of calcitriol which is decreased when the glomerular filtration rate falls below 30 ml/min. Consequently, intestinal malabsorption of calcium and phosphate and the resulting hypocalcemia are improved, thereby reversing the signs and symptoms of bone disease.
In patients with established post-menopausal osteoporosis, Calcitriol increases calcium absorption, elevates circulating levels of calcitriol and reduces vertebral fracture frequency.
Hyperparathyroidism in renal failure: 0.25 mcg/day or alternate day. May increase slowly. Hypoparathyroidism or pseudohypoparathyroidism: 0.5-2 mcg once daily. Vitamin D dependent rickets: 0.015-0.02 mcg/kg/day. Maintenance: 0.03-0.06 mcg/kg/day. Max: 2 mcg/day. Hyperparathyroidism in dialysis patients: 0.5-4 mcg 3 times/wk. Max: 8 mcg 3 times/wk. Hyperparathyroidism in renal failure: 0.5 mcg 3 times/wk, may increase by 0.25-0.5 mcg at 2-4 wk intervals. Maintenance: 0.5-3 mcg 3 times/wk.
Reduced absorption of tetracyclines, quinolones and oral biphosphates with concurrent calcium use. Calcium absorption may be reduced by corticosteroids. Increased risk of hypercalcaemia and metabolic alkalosis with thiazide diuretics. High blood calcium level may increase the efect of cardiac glycosides. Reduced erlotinib efcacy with calcium. Increased risk of hypercalcaemia with paricalcitol. Enzyme inducing antiepileptics increases the metabolism of vitamin D. Fatal encephalopathy can occur in patients with renal failure when given calcium citrate and aluminium products concurrently due to marked rise in aluminium levels.
Hypercalcaemia; evidence of vitamin D toxicity, pregnancy & lactation. Idiopathic hypercalcaemia. Pediatric doses must be individualised and monitored under close medical supervision. Coronary disease, renal function impairment and arteriosclerosis, especially in the elderly. Hypoparathyroidism.
Weakness; headache; somnolence; nausea; vomiting; dry mouth; constipation; muscle pain; bone pain; metallic taste; polyuria; polydipsia; anorexia; irritability; weight loss; nocturia; mild acidosis; reversible azotemia; generalized vascular calcification; nephrocalcinosis; conjunctivitis (calcific); pancreatitis; photophobia; rhinorrhoea; pruritus; hyperthermia; decreased libido; elevated BUN; albuminuria; hypercholesterolaemia; elevated AST and ALT; ectopic calcification; hypertension; cardiac arrhythmias.
Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Store at a cool and dry place below 25°C protected from light and moisture. Keep out of the reach of children.
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