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Oral doses of Rocaltrolcalcitriolranging from 10 to 55 ng/kg/day have been shown to improve calcium homeostasis and bone disease in pediatric patients with chronic renal failure for whom hemodialysis is not yet requiredpredialysisLong-term calcitriol therapy is well tolerated by pediatric patientsThe most common safety issues are mildtransient episodes of hypercalcemiahyperphosphatemiaand increases in the serum calcium times phosphateCa x Pproduct which are managed effectively by dosage adjustment or temporary discontinuation of the vitamin D derivative.
Rocaltrolcalcitriolshould not be given to patients with hypercalcemia or evidence of vitamin D toxicityUse of Rocaltrolcalcitriolin patients with known hypersensitivity to Rocaltrolcalcitriolor drugs of the same classor any of the inactive ingredients is contraindicated.
In the rabbitdosages of 0.3 mcg/kg/dayapproximately 6 times maximum recommended dose based on surface areaadministered on days 7 to 18 of gestation resulted in 19maternal mortalitya decrease in mean fetal body weight and a reduced number of newborn surviving to 24 hoursA study of perinatal and postnatal development in rats resulted in hypercalcemia in the offspring of dams given Rocaltrolcalcitriolat doses of 0.08 or 0.3 mcg/kg/dayapproximately 1 and 3 times the maximum recommended dose based on mg/m 2hypercalcemia and hypophosphatemia in dams given Rocaltrolcalcitriolat a dose of 0.08 or 0.3 mcg/kg/dayand increased serum urea nitrogen in dams given Rocaltrolcalcitriolat a dose of 0.3 mcg/kg/dayIn another study in ratsmaternal weight gain was slightly reduced at a dose of 0.3 mcg/kg/dayapproximately 3 times the maximum recommended dose based on mg/m 2administered on days 7 to 15 of gestationThe offspring of a woman administered 17 mcg/day to 36 mcg/day of Rocaltrolcalcitriolapproximately 17 to 36 times the maximum recommended doseduring pregnancy manifested mild hypercalcemia in the first 2 days of life which returned to normal at day 3.
Stop using calcitriol and call your doctor at once if you have a serious side effect such as:
Capsules0.5 mcg calcitriol in soft gelatindark orangeoblong capsulesimprinted with ROCALTROLcalcitriol0.5 ROCHEbottles of 100NDC 0004-0144-01
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