Each soft gelatin capsule contains Calcitriol BP 0.25 mcg.
Calcitriol is a synthetic vitamin D analog. It is a white, crystalline
compound which occurs naturally in humans. It is soluble in organic solvents
but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-
5,7,10(19)-cholestatriene-1˜, 3˜, 25-triol. The other names frequently used
forcalcitriol are 1˜, 25-dihydroxy-cholecalciferol, 1,25-dihydroxyvitamin D3,
1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.
Predialysis Patients: Calcitol is indicated in the management of
secondaryhyperparathyroidism and resultant metabolic bone disease in
patients with moderate to severe chronic renal failure .
Dialysis Patients: Calcitol is indicated in the management of hypocalcemiaand
the resultant metabolic bone disease in patients undergoing chronic renal
dialysis. In these patients, Calcitol administration enhances calcium absorption,
reduces serum alkaline phosphatase levels, and may reduce elevated
parathyroid hormone levels.
Hypoparathyroidism Patients: Calcitol is also indicated in the management of
hypocalcemia and its clinical manifestations in patients with postsurgical
hypoparathyroidism, idiopathic hypoparathyroidism, and
DOSAGE & ADMINISTRATION:
Calcitoltherapy should always be started at
the lowest possible dose and should not be increased without careful
monitoring of serum calcium.During the titration period of treatment with
Calcitol, serum calcium levels should be checked at least twice weekly.
the optimal dosage of Calcitol has been determined, serum calcium levels
should be checked every month. Dialysis Patients: The recommended initial
dose of Calcitol 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 at 4 to 8 week intervals. During this titration period,
serum calcium levels should be obtained at least twice weekly, and if
hypercalcemia is noted, the drug should be immediately discontinued until
normocalcemia ensues. Phosphorus, magnesium, and alkaline phosphatase
should be determined periodically. Patients with normal or only slightly reduced
serum calcium levels may respond to Calcitol doses of 0.25 mcg every other
day. Most patients undergoing hemodialysis respond to doses between 0.5
and 1 mcg/day. Safety and effectiveness of Calcitol in pediatric patients
undergoing dialysis have not been established.
Hypoparathyroidism: The recommended initial dosage of Calcitol 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, Calcitol should be immediately discontinued until
normocalcemia ensures. 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 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 0.25 mcg to 0.75 mcg daily. Dosing
guidelines have not been established for pediatric patients under 1 year of age
withhypoparathyroidismor for pediatric patients less than 6 years of age with
pseudohypoparathyroidism. Malabsorption is occasionally noted in patients
withhypoparathyroidism; hence, larger doses of Calcitol may be needed.
Predialysis Patients: The recommended initial dosage of Calcitol 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.For pediatric patients less than 3 years
of age, the recommended initial dosage of Calcitol is 10 to 15 ng/kg/day.
Administration of Calcitol to patients in excess of their daily
requirements can cause hypercalcemia, hypercalciuria, and
hyperphosphatemia. Since calcitriolis a derivative of vitamin D, the signs and
symptoms of overdose are the same as for an overdose of vitamin D.
Calcitol should not be given to patients with
hypercalcemia or evidence of vitamin D toxicity. Use of Calcitol in patients with
known hypersensitivity to Calcitol (or drugs of the same class) or any of the
inactive ingredients is contraindicated.
Excessive dosage of
Calcitol induces hypercalcemia and in some instances hypercalciuria; therefore,
early in treatment during dosage adjustment, serum calcium should be
determined twice weekly. Take care to ensure correct dose in infants; monitor
plasma calcium in patients receiving high doses and in renal impairment. If
hypercalcemia develops, treatment with Calcitol should be stopped
Symptoms of overdosage include anorexia,
lassitude, nausea and vomiting, diarrhea, weight loss, polyuria, sweating,
headache, thirst, vertigo and raised concentration of calcium and phospha