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Dosing and Administration
The optimal daily dose of Rocaltrol must be carefully determined for each patient. Rocaltrol can be
administered orally either as a capsule (0.25 mcg or 0.50 mcg) or as an oral solution (1 mcg/ml).
Rocaltrol therapy should always be started at the lowest possible dose and should not be increased
without careful monitoring of serum calcium.
The effectiveness of Rocaltrol therapy is predicated on the assumption that each patient is receiving
an adequate but not excessive daily intake of calcium. Patients are advised to have a dietary intake
of calcium at a minimum of 600 mg daily. The U.S. R.D.A. for calcium in adults is 800 mg to 1200 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.
Because of improved calcium absorption from the gastrointestinal tract, some patients on Rocaltrol
may be maintained on a lower calcium intake. Patients who tend to develop hypercalcemia may require
only low doses of calcium or no supplementation at all.
During the titration period of treatment with Rocaltrol, serum calcium levels should be checked at
least twice weekly. When the optimal dosage of Rocaltrol has been determined, serum calcium levels
should be checked every month (or as given below for individual indications). Samples for serum
calcium estimation should be taken without a tourniquet.
Hypoparathyroidism
Adult RECOMMENDED DOSE: The recommended initial dosage of Rocaltrol is 0.25 mcg/day given in the
morning. If a satisfactory response in the biochemical parameters and clinical manifestations of the
disease is not observed, the dose may be increased at 2- to 4-week intervals. During the dosage
titration period, serum calcium levels should be obtained at least twice weekly and, if hypercalcemia
is noted, Rocaltrol should be immediately discontinued until normocalcemia ensues (see full
prescribing information PRECAUTIONS: General). Careful consideration should also be given to
lowering the dietary calcium intake. Serum calcium, phosphorus, and 24-hour urinary calcium
should be determined periodically.
Most adult patients have responded to dosages in the range of 0.5 mcg to 2 mcg daily.
Pediatric RECOMMENDED DOSE: Most pediatric patients age 6 years and older have responded to dosages
in the range of 0.5 mcg to 2 mcg daily.
Pediatric patients in the 1 to 5 year age group with hypoparathyroidism have usually been given
0.25 mcg to 0.75 mcg daily.
Dosing guidelines have not been established for pediatric patients under 1 year of age with
hypoparathyroidism The number of treated patients with pseudohypoparathyroidism less than 6 years
of age is too small to make dosage recommendations.
Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of
Rocaltrol may be needed.
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References:
1. Rocaltrol [package insert]. Parsippany, NJ: Validus Pharmaceuticals; 2009.
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| © February 2012 Validus Pharmaceuticals LLC. All rights reserved. ROC-039-09 |
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Important Safety Information for Rocaltrol® (calcitriol) Capsules and Oral solution
Rocaltrol should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. If hypercalcemia develops in a
patient receiving Rocaltrol, treatment should be immediately discontinued. In treating chronic hypocalcemia and resultant metabolic
bone disease in patients undergoing chronic dialysis, the optimal dose must be carefully determined for each patient. During the
titration period of treatment with Rocaltrol, serum calcium levels should be checked at least twice daily. Reassessment and
correction of dosage may be necessary.
Since Rocaltrol is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general,
similar to those encountered with excessive vitamin D intake, ie, hypercalcemia syndrome or calcium intoxication (depending on
the severity and duration of hypercalcemia). Normalization of elevated serum calcium occurs within a few days of treatment withdrawal
(ie, faster than in treatment with vitamin D3 preparations). Chronic hypercalcemia may lead to generalized calcification,
nephrocalcinosis and other soft tissue calcification. The serum calcium times phosphate (Ca X P) product should not exceed 70
mg2/dL2. Overdose may require immediate medical attention.
Use with caution in patients receiving digitalis, as this may cause cardiac arrhythmias.
The information on this site is intended for reference only. It should not be used for prescribing or dispensing products; consult
the attached full prescribing information. |
