Composition: Each capsule contains: Calcitriol IP 0.25mg

Calcitriol is vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. It is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. The drug is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol.

Mechanism of action:

This drug increases blood calcium levels ( [Ca2+] ) by promoting absorption of dietary calcium from the gastrointestinal tract and increasing renal tubular reabsorption of calcium thus reducing the loss of calcium in the urine. It also stimulates release of calcium from bone by its action on the specific type of bone cells referred to as osteoblasts, which in turn activates osteoclasts.

Indications : This drug is prescribed forTreatment of hypocalcaemia – hypoparathyroidism, osteomalacia (adults), rickets (infants, children), renal osteodystrophy, chronic renal dialysisTreatment of osteoporosisPrevention of corticosteroid-induced osteoporosis.
Drug interaction:Cholestyramine : Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of this drug.Phenytoin/Phenobarbital : The coadministration of phenytoin or phenobarbital will not affect plasmaconcentrations of this drug, but may reduce endogenous plasma levels of 25(OH)D3 by accelerating metabolism. Since blood level of calcitriol will be reduced, higher doses of this drug may be necessary if these drugs are administered simultaneously.Thiazides : Thiazides are known to induce hypercalcemia by the reduction of calcium excretion in urine. Some reports have shown that the concomitant administration of thiazides with Rocaltrol (calcitriol) causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary.Digitalis : Calcitriol dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias.Ketoconazole : Ketoconazole may inhibit both synthetic and catabolic enzymes of this medication. Reductions in serum endogenous calcitriol concentrations have been observed following the administration of 300 mg/day to 1200 mg/day ketoconazole for a week to healthy men.Corticosteroids : A relationship of functional antagonism exists between vitamin D analogues, which promote calcium absorption, and corticosteroids, which inhibit calcium absorption.Phosphate-Binding Agents : Since Rocaltrol (calcitriol) also has an effect on phosphate transport in theintestine, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration. Vitamin D : Since calcitriol is the most potent active metabolite of vitamin D3, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with this drug to avoid possible additive effects and hypercalcemia.Calcium Supplements : Uncontrolled intake of additional calcium-containing preparations should be avoided.Magnesium : Magnesium-containing preparations (eg, antacids) may cause hypermagnesemia and should therefore not be taken during therapy with this medicine by patients on chronic renal dialysis.
Side effects : Stop using this medicine and if you have a serious side effect such as:weakness, headache, drowsiness;nausea, vomiting, stomach pain, constipation;loss of appetite;dry mouth, increased thirst;metallic taste in mouth;urinating more than usual;fast, slow, or uneven heart rate;changes in behavior;Muscle pain, bone.

Over dose:

Administration of this medicine to patients in excess of their daily requirements can cause hypercalcemia, hypercalciuria, andhyperphosphatemia. High intake of calcium and phosphate concomitant with Rocaltrol (calcitriol) may lead to similar abnormalities. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg2/dL2. High levels of calcium in the dialysate bath may contribute to the hyperkalemia .

Dosage : An oral calcitriol dose for hypocalcemia is 0.25 micrograms per day, which can be increased by 0.25 micrograms per dosage at four- to eight-week intervals.

Storage : Store at room temperature between 59-86 degrees F (15-30 degrees C) and keep away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.