Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CALCITRIOL (UNII: FXC9231JVH) (CALCITRIOL - UNII:FXC9231JVH)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
Calcitriol capsules are 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. 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. Calcitriol capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyro
Product: 50090-6711 NDC: 50090-6711-0 30 CAPSULE, LIQUID FILLED in a BOTTLE
Abbreviated New Drug Application
CALCITRIOL- CALCITRIOL CAPSULE, LIQUID FILLED A-S MEDICATION SOLUTIONS ---------- CALCITRIOL CAPSULE, LIQUID FILLED RX ONLY DESCRIPTION Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol Capsules contain 0.25 mcg or 0.5 mcg calcitriol, fractionated triglyceride of coconut oil, butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. Gelatin capsule shells contain glycerin, water, sorbitol, sorbitan, mannitol, water, FD&C Yellow No. 6, FD&C Red #40, titanium dioxide and iron oxide black. Calcitriol is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene- 1α, 3β, 25-triol and has the following structural formula: The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1,25- dihydroxyvitamin D , 1,25-DHCC, 1,25(OH) D and 1,25-diOHC. CLINICAL PHARMACOLOGY Man's natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin D (cholecalciferol). Vitamin D must be metabolically activated in the liver and the kidney before it is fully active as a regulator of calcium and phosphorus metabolism at target tissues. The initial transformation of vitamin D is catalyzed by a vitamin D -25-hydroxylase enzyme (25- OHase) present in the liver, and the product of this reaction is 25 hydroxyvitamin D [25-(OH)D ]. Hydroxylation of 25-(OH)D occurs in the mitochondria of kidney tissue, activated by the renal 25-hydroxyvitamin D -1 alpha-hydroxylase (alpha-OHase), to produce 1,25-(OH) D (calcitriol), the active form of vitamin D . Endogenous synthesis and catabolism of calcitriol, as well as physiological control mechanisms affecting these 3 2 3 3 3 3 3 3 3 3 3 2 3 3 proc Læs hele dokumentet