Country: United States
Language: English
Source: NLM (National Library of Medicine)
Calcitriol (UNII: FXC9231JVH) (Calcitriol - UNII:FXC9231JVH)
Akorn
Calcitriol
Calcitriol 1 ug in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Calcitriol injection should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Calcitriol injection is contraindicated in patients with previous hypersensitivity to calcitriol or any of its excipients.
Calcitriol Injection, USP is supplied in 1 mL ampules containing 1 mcg. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. NOVAPLUS is a registered trademark of Vizient, Inc. Manufactured by: Akorn, Inc. Lake Forest, IL 60045 NOVAPLUS ® NVCL00N Rev. 06/16
Abbreviated New Drug Application
CALCITRIOL- CALCITRIOL INJECTION AKORN ---------- CALCITRIOL INJECTION, USP 1 mcg/mL RX only DESCRIPTION Calcitriol Injection is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcitriol Injection, USP is available in 1 mL ampules. Each 1 mL contains: Active: Calcitriol, 1 mcg. Inactives: Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Edetate Disodium, Dihydrate 1.1 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Polysorbate 20, 4 mg; Sodium Ascorbate 10 mg; Sodium Chloride 1.5 mg; pH Range is from 6.5 to 8.0 and Water for Injection. Calcitriol is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water. Calcitriol is chemically designated (5Z, 7E)-9,10 secocholesta 5,7,10(19)-triene-1α, 3β, 25-triol and has the following structural formula: The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol,1α, 25- dihydroxyvitamin D ,1,25-DHCC,1,25(OH) D and 1,25-diOHC. CLINICAL PHARMACOLOGY Calcitriol is the active form of vitamin D (cholecalciferol). The natural or endogenous supply of vitamin D in man mainly depends on ultraviolet light for conversion of 7- dehydrocholesterol to vitamin D in the skin. Vitamin D must be metabolically activated in the liver and the kidney before it is fully active on its target tissues. The initial transformation is catalyzed by a vitamin D -25- hydroxylase enzyme present in the liver, and the product of this reaction is 25-(OH)D (calcifediol). The latter undergoes hydroxylation in the mitochondria of kidney tissue, and this reaction is activated by the renal 25-hydroxyvitamin D -1 α-hydroxylase to produce 1,25-(OH) D (calcitriol), the active form of vitamin D . The known sites of action of calcitriol are intestine, bone, kidney and parathyroid gland. 3 2 3 3 3 3 3 3 3 2 3 3 Calcitriol is the most active known form of vitamin D in stimulating intestinal calcium transport. In ac Read the complete document