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Manufacturer
STRIDES PHARMA
SKU
64380072406

calcitriol 0.5 mcg capsule

Generic
$0.50 / capsule
$1.94 / capsule
$1.44 / capsule
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Dosage and Administration

Administration

Calcitriol is administered orally or by IV injection, usually in a single dose daily.

Dosage

During therapy with calcitriol, dosage depends on the nature and severity of the patient's hypocalcemia and must be individualized to maintain serum calcium concentrations of 9-10 mg/dL. The manufacturers recommend that serum calcium concentrations be measured at least twice weekly during initial dosage adjustments and after subsequent dosage changes; however, some clinicians recommend that serum calcium concentrations be measured at least weekly for the first 12 weeks of therapy and monthly after stabilization of dosage.

Renal Failure

Oral Dosage

For the management of hypocalcemia and resultant metabolic bone disease in patients with chronic renal failure undergoing dialysis, the usual initial adult oral dosage of calcitriol is 0.25 mcg daily. Some patients with normal or slightly reduced serum calcium concentrations require only 0.25 mcg every other day. If adequate clinical and biochemical responses are not obtained with the initial dosage, the dosage may be increased by 0.25 mcg daily at 4- to 8-week intervals. If hypercalcemia occurs during titration of dosage, calcitriol should be withheld until normocalcemia ensues; the drug can then be reinstituted at a dosage less than that which induced hypercalcemia. Most patients undergoing hemodialysis require oral calcitriol dosages of 0.5-1 mcg daily.

In children undergoing hemodialysis, oral calcitriol dosages of 0.25-2 mcg daily have been used to increase serum calcium and decrease parathyroid hormone concentrations.

IV Dosage

For the management of hypocalcemia in patients with chronic renal failure undergoing hemodialysis, the usual initial adult IV dosage of calcitriol is 0.5 mcg (0.01 mcg/kg) 3 times weekly, approximately every other day. The drug may be administered IV by rapid injection through the catheter at the end of a period of hemodialysis. If adequate clinical and biochemical responses are not obtained with the initial dosage, the dose given 3 times weekly may be increased by 0.25-0.5 mcg at 2- to 4-week intervals. If hypercalcemia occurs during titration of dosage, calcitriol should be withheld until normocalcemia ensues; the drug can then be reinstituted at a dosage less than that which induced hypercalcemia. Most patients require IV calcitriol dosages of 0.5-3 mcg (0.01-0.05 mcg/kg) 3 times weekly.

Predialysis

For the management of secondary hyperparathyroidism and resultant metabolic bone disease in adults and pediatric patients 3 years of age and older with moderate to severe renal failure (creatinine clearance of 15-55 mL/minute, corrected for surface area in children) not yet on dialysis, the usual initial oral dosage of calcitriol is 0.25 mcg once daily. If necessary, the dosage may be increased to 0.5 mcg once daily. For predialysis pediatric patients younger than 3 years of age, the usual initial oral dosage of calcitriol is 0.01-0.015 mcg/kg once daily.

Hypoparathyroidism and Pseudohypoparathyroidism

For the management of hypoparathyroidism and pseudohypoparathyroidism in adults and children 1 year of age and older, the usual initial oral dosage of calcitriol is 0.25 mcg daily. If adequate clinical and biochemical responses are not obtained with the initial dosage, the dosage may be increased at 2- to 4-week intervals. If hypercalcemia occurs during titration of dosage, calcitriol should be withheld until normocalcemia ensues; the drug can then be reinstituted at a dosage less than that which induced hypercalcemia. Lowering the patient's dietary calcium intake should also be considered. Most adults and children 6 years of age and older require oral calcitriol dosages of 0.5-2 mcg daily. Most children 1-5 years of age with hypoparathyroidism require oral calcitriol dosages of 0.25-0.75 mcg daily; because of the limited number of children younger than 6 years of age who have received calcitriol for the management of pseudohypoparathyroidism, specific dosage recommendations for these children do not currently exist. A pediatric oral dosage of 0.04-0.08 mcg/kg daily has also been used.

Other Uses

In children and a few adults with vitamin D-dependent rickets, an oral calcitriol dosage of 1 mcg daily has been used to control serum calcium and treat rickets or osteomalacia. In 2 adults with unusual resistance to calcitriol therapy, 12-17 mcg daily was needed to maintain normocalcemia.

In a few patients with familial hypophosphatemia (vitamin D-resistant rickets), 2.1 mcg of oral calcitriol daily increased serum calcium concentrations. Oral phosphate salts may be administered concomitantly.

To manage hypocalcemia in premature infants, 1 mcg of oral calcitriol daily has been used during the first 5 days of life. To control hypocalcemic tetany in premature infants, some clinicians have used an IV calcitriol dosage of 0.05 mcg/kg daily for 5-12 days.

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