Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
CALCITRIOL (UNII: FXC9231JVH) (CALCITRIOL - UNII:FXC9231JVH)
Sun Pharmaceutical Industries, Inc.
CALCITRIOL
CALCITRIOL 0.25 ug
ORAL
PRESCRIPTION DRUG
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 hypoparathyroidi
Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01). Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01). Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59). Calcitriol Capsules and Oral Solution should be protected from light. Store at 59° to 86°F (15° to 30°C). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
New Drug Application Authorized Generic
CALCITRIOL- CALCITRIOL CAPSULE CALCITRIOL- CALCITRIOL SOLUTION SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- CALCITRIOL CAPSULES AND ORAL SOLUTION 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 is available as capsules containing 0.25 mcg or 0.5 mcg calcitriol and as an oral solution containing 1 mcg/mL of calcitriol. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil, and the oral solution contains a fractionated triglyceride of palm seed oil. Gelatin capsule shells contain glycerin, and sorbitol, with the following dye systems: 0.25 mcg — FD&C Yellow No. 6 and titanium dioxide; 0.5 mcg — FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. The oral solution contains no additional adjuvants or coloring principles. 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 ]. H Baca dokumen lengkapnya