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Calcitriol (Calcitriol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Calcitriol Injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.

DOSAGE AND ADMINISTRATION

The optimal dose of Calcitriol Injection must be carefully determined for each patient.

The effectiveness of Calcitriol Injection therapy is predicated on the assumption that each patient is receiving an adequate and appropriate daily intake of calcium. The RDA for calcium in adults is 800 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

The recommended initial dose of Calcitriol Injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals. During this titration period, serum calcium and phosphorus levels should be obtained at least twice weekly. If hypercalcemia or a serum calcium times phosphate product greater than 70 is noted, the drug should be immediately discontinued until these parameters are appropriate. Then, the Calcitriol Injection dose should be reinitiated at a lower dose. Doses may need to be reduced as the PTH levels decrease in response to the therapy. Thus, incremental dosing must be individualized and commensurate with PTH, serum calcium and phosphorus levels. The following is a suggested approach in dose titration:

PTH Levels Calcitriol Injection Dose
the same or increasingincrease
decreasing by <30%increase
decreasing by >30%, <60%maintain
decreasing by >60%decrease
one and one-half to three times the upper limit of normalmaintain

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard unused portion.

HOW SUPPLIED

Calcitriol Injection is supplied as follows:

List Container Concentration Fill
3198Ampul1 mcg/mL1 mL

PROTECT FROM LIGHT.

Store at controlled room temperature 15o to 30oC (59o to 86oF).

Rx Only
Printed in USA

NEPHRX 2007
Distributed by: NEPHRX, LLC, Brockton, MA 02301, USA

R5-10/07

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