Calcit Sg 0.25Mg

THERAPEUTIC INDICATIONS

Calcitrol Capsule is indicated for the Correction of the abnormalities of calcium and phosphate metabolism in patients with renal osteodystrophy Calcitrol Capsule is also indicated for the treatment of established postmenopausal osteoporosis. 

CONTRAINDICATIONS

Calcitriol Capsule is contraindicated: in all diseases associated with hypercalcemia, in patients with evidence of metastatic calcification, in patients with known hypersensitivity to calcitriol (or drugs of the same class) and any of the constituent excipients, if there is evidence of vitamin D toxicity. 

SPECIAL WARNINGS & PRECAUTIONS FOR USE

There is a close correlation between treatment with and the development of hypercalcemia. All other vitamin D compounds and their derivatives, including proprietary compounds or foodstuffs which may be "fortified" with vitamin D, should be withheld during treatment with Calcitriol capsule. An abrupt increase in calcium intake as a result of changes in diet (e.g. increased consumption of dairy products) or uncontrolled intake of calcium preparations may trigger hypercalcemia. Patients and their families should be advised that strict adherence to the prescribed diet is mandatory, and they should be instructed on how to recognize the symptoms of hypercalcemia. As soon as the serum calcium levels rise to 1mg/100ml (250µmol/l} above normal (9-11mg/100ml or 2250-2750 µmol/l), or serum creatinine rises to >120µmol/l, treatment with calcitriol capsule should be stopped immediately until normocalcaemia ensues (see section. Posology and method of administration). Immobilized patients. e.g. those who have undergone surgery, are particularly exposed to the risk of hypercalcemia. Calcitriol increases inorganic phosphate levels serum. While this is desirable in patients with hypophosphatemia, caution is called for in patients with renal failure because of the danger of ectopic calcification. In such cases, the plasma phosphate level should be maintained at the normal level (2-5mg/100ml or 0.65-1.62mmol/l) by the oral administration of appropriate phosphate-binding agents and phosphate diet. The serum calcium times phosphate (Ca x P) product Should not be allowed to exceed 70mg 2/dl 2. 

OVERDOSE

Treatment of asymptomatic hypercalcemia (see section Posology and method of administration). Since calcitriol is a derivative of vitamin D the symptoms of overdose are the same as for an overdose of vitamin D. Intake of high doses of calcium and phosphate together with Calcitriol Capsule may give rise to similar symptoms. The serum calcium times phosphate (CaxP) product should not be allowed to exceed 70mg 2/dl 2. A high calcium level in the dialysate may contribute to the development of hypercalcemia. Acute symptoms of vitamin D intoxication: anorexia, headache, vomiting, constipation. Chronic symptoms: dystrophy (weakness, BSS of weight). sensory disturbances, possibly fever with thirst. polyuria, dehydration, apathy. arrested growth and urinary tract infections. Hypercalcemia ensues, with metastatic calcification of the renal cortex. myocardium, lungs and pancreas. 

CADILA HEALTHCARE LIMITED