Calcitriol 0.0005 MG Oral Capsule
INDICATIONS AND USAGE Predialysis Patients Calcitriol capsules re 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 capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules 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 capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
Amneal Pharmaceuticals LLC
OVAL ORANGE A76
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Calcitriol 0.00025 MG Oral Capsule
Amneal Pharmaceuticals LLC
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HOW SUPPLIED
CALCITRIOL capsules 0.25 mcg are supplied as opaque orange color, oval shaped capsules, imprinted with “A19”. They are available as follows: Bottles of 30: NDC 65162-519-03 Bottles of 100: NDC 65162-519-10 Bottles of 250: NDC 65162-519-25
CALCITRIOL capsules 0.5 mcg are supplied as opaque orange color, oblong capsules, imprinted with “A76”. They are available as follows: Bottles of 30: NDC 65162-576-03 Bottles of 100: NDC 65162-576-10 Bottles of 250: NDC 65162-576-25
CALCITRIOL capsules should be protected from light. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. REFERENCE 1. Jones CL, et al. Comparisons between oral and intraperitoneal 1,25-dihydroxyvitamin D 3 therapy in children treated with peritoneal dialysis. Clin Nephrol . 1994; 42:44-49. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 11-2015-00
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