Calcitriol BP
Composition : Each dicaltrol
soft gelatin capsule contains calcitriol BP 0.25mcg.
Indications : Predialysis
patients : Dicaltrol is indicated in the management of secondary
hyperparathyroidism and resultant metabolic bone disease in patients with moderate
to severe chronic renal failure not yet on dialysis. In children, the
creatinine clearance value must be corrected for a surface area of 1.73 square
meters..
Dosage & Administration : Predialysis
Patients : The
recommended initial dosage of Dicaltrol is 0.25 mcg/day in adults and pediatric
patients 3 years of age and older. This dosage may be increased if necessary to
0.5 mcg/day.
Dialysis
Patients : The
recommended initial dose of Dicaltrol
is 0.25 mcg/day. If a satisfactory response in the biochemical parameters
and clinical manifestations of the disease state is not observed, dosage
may be increased by 0.25 mcg/day at 4 to 8 week intervals. During this
titration period, serum calcium levels should be obtained at least twice
weekly, and if hypercalcaemia is noted, the drug should be immediately
discontinued until normocalcaemia ensues. Patients with normal or
only slightly reduced serum calcium levels may respond to Dicaltrol doses of 0.25 mcg
every other day. Most patients undergoing hemodialysis respond to doses
between 0.5 and 1mcg/day.
Hypoparathyroidism
: The
recommended initial dosage of Dicaltrol
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 hypercalcaemia is noted, Dicaltrol
should be immediately discontinued until normocalceamia ensues.
Careful consideration should also be given to lowering the dietary calcium
intake. Most adult patients and 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
0.25mcg to 0.75mcg daily. The number of treated patients with
pseudohypoparathyroidism
less than 6 years of age is too small to make dosage recommendations.
Postmenopausal
Osteoporosis : The
recommended dose for Dicaltrol is
0.25 mcg twice daily. Serum calcium and creatinine levels should bedetermined
at 4 weeks, 3 and 6 months and at 6 monthly intervals there after.
Use in pregnancy and lactation : Use in pregnancy and lactation Dicaltrol should be given only when
the potential benefit has been weighed against the possible hazard to the
fetus. Mothers should not breast-feed while taking Dicaltrol.
Packing : Each box contains 60's capsule in
blister pack.