ROCALTROL CAPSULE 0.25 MCG [SIN03865P]

Product Info

ROCALTROL CAPSULE 0.25 MCG

[SIN03865P]

2.1 Therapeutic Indication(s)

Established postmenopausal osteoporosis.

Renal osteodystrophy in patients with chronic renal failure, particularly those undergoing hemodialysis.

Postsurgical hypoparathyroidism.

Idiopathic hypoparathyroidism.

Pseudohypoparathyroidism.

Vitamin D-dependent rickets.

Hypophosphatemic vitamin D-resistant rickets.

2.2 Dosage and Administration

The optimal daily dose of Rocaltrol must be carefully determined for each patient on the basis of the serum calcium level. Rocaltrol therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium (see Patient monitoring).

A prerequisite for optimal efficacy of Rocaltrol is adequate but not excessive calcium intake at the beginning of therapy. Calcium supplements may be necessary and should be administered according to local guidelines.

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 hypercalcaemia may require only low doses of calcium or no supplementation at all.

Patient monitoring
During the stabilization phase 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.

As soon as the serum calcium levels rise to 1 mg/100 ml (250 micromole/l) above normal (9 to 11 mg/100 ml, or 2250–2750 micromole/l), or serum creatinine rises to > 120 micromole/l, treatment with Rocaltrol should be stopped immediately until normocalcaemia ensues.

During the periods of hypercalcaemia, serum calcium and phosphate levels must be determined daily. When normal levels have been attained, the treatment with Rocaltrol can be continued, at a daily dose 0.25 mcg lower than that previously used. An estimate of daily dietary calcium intake should be made and the intake adjusted when indicated.

2.2.1 Special Dosage Instructions

• Postmenopausal osteoporosis:
  The recommended dosage for Rocaltrol is 0.25 mcg twice daily.

  Serum calcium and creatinine levels should be determined at 1, 3, and 6 months and at 6- month intervals thereafter.

• Renal osteodystrophy (dialysis patients):
  The initial daily dose is 0.25 mcg. In patients with normal or only slightly reduced serum calcium levels, doses of 0.25 mcg every other day are sufficient. If no satisfactory response in the biochemical parameters and clinical manifestations of the disease is observed within 2–4 weeks, the daily dosage may be increased by 0.25 mcg at two to four-week intervals. During this period, serum calcium levels should be determined at least twice weekly. Most patients respond to dosages between 0.5 mcg and 1.0 mcg daily.

  An oral Rocaltrol pulse therapy with an initial dosage of 0.1 mcg/kg/week split into two or three equal dosages given at night was found effective even in patient refractory to continuous therapy. A maximum total cumulative dosage of 12 mcg per week should not be exceeded.

• Hypoparathyroidism, rickets:
  The recommended initial dose 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 two to four-week intervals. During this period, serum calcium levels should be determined at least twice weekly. If hypercalcemia is noted, Rocaltrol should be immediately discontinued until normocalcaemia ensues. Careful consideration should also be given to lowering the dietary calcium intake.

  Malabsorption is occasionally noted in patients with hypoparathyroidism; hence, larger doses of Rocaltrol may be needed.

  If the physician decides to prescribe Rocaltrol to a pregnant woman with hypoparathyroidism, an increased dose may be required during the latter half of gestation, with dose reduction postpartum or during lactation.

• Elderly patients:
  No specific dosage modifications are required in elderly patients. The general recommendations for monitoring serum calcium and creatinine should be observed.

• Pediatric patients:
  The safety and efficacy of calcitriol capsules in children have not been sufficiently investigated to enable dosing recommendations.

2.3 Contraindications

Rocaltrol is contraindicated in all diseases associated with hypercalcaemia. Use of Rocaltrol in patients with known hypersensitivity to calcitriol (or drugs of the same class) and any of the constituent excipients is contraindicated.

Rocaltrol is contraindicated if there is evidence of vitamin D toxicity.