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Calcitol

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  • မြန်မာ

 CONTENTS:

Each soft gelatin capsule contains Calcitriol BP 0.25 mcg.

 

DESCRIPTION:

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.

 

INDICATIONS:

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.

When

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.

 

OVERDOSAGE:

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.

 

CONTRAINDICATIONS:

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.

 

PRECAUTIONS:

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

immediately.

 

SIDE EFFECTS:

Symptoms of overdosage include anorexia,

lassitude, nausea and vomiting, diarrhea, weight loss, polyuria, sweating,

headache, thirst, vertigo and raised concentration of calcium and phospha


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