calcitriol 0.5 mcg
INDICATIONS AND USAGE Predialysis Patients Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
sun pharmaceutical industries, inc.
OVAL BROWN 968
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HOW SUPPLIED
CALCITRIOL capsules are available as follows: 0.25 mcg - peach colored oval, soft gelatin capsule imprinted with ‘967’ in black ink, containing clear, colorless to slightly yellowish oily liquid. Bottles of 30 with child-resistant cap…………………..NDC 62756-967-83 Bottles of 100 with child-resistant cap…………………NDC 62756-967-88 Bottles of 1000.............................................……….….NDC 62756-967-18 0.5 mcg - brown colored oval, soft gelatin capsule imprinted with ‘968’ in black ink, containing clear, colorless to slightly yellowish oily liquid. Bottles of 30 with child-resistant cap…………………..NDC 62756-968-83 Bottles of 100 with child-resistant cap………………..NDC 62756-968-88 Bottles of 1000..........................................……….….NDC 62756-968-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
CALCITRIOL capsules should be protected from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
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