CALCITRIOL solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

CALCITRIOL (UNII: FXC9231JVH) (CALCITRIOL - UNII:FXC9231JVH)

Inapatikana kutoka:

Rising Pharmaceuticals, Inc.

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Predialysis Patients Calcitriol Oral Solution 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 Oral Solution is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Calcitriol Oral Solution 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 Oral Solution is also indicated in the management of hypocalcemia and its clinical manif

Bidhaa muhtasari:

Oral Solution: a clear, colorless 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: 64980-447-15 Calcitriol Oral Solution should be protected from light. Store at 59° to 86°F (15° to 30°C). 1. Jones CL, et al. Comparisons between oral and intraperitoneal 1,25-dihydroxyvitamin D3 therapy in children treated with peritoneal dialysis. Clin Nephrol. 1994; 42:44-49. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07763 Issued March 2018

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CALCITRIOL- CALCITRIOL SOLUTION
RISING PHARMACEUTICALS, INC.
----------
CALCITRIOL
DESCRIPTION
Calcitriol Oral Solution 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 oral
solution contains 1 mcg/mL of calcitriol. Calcitriol Oral Solution
contains butylated hydroxyanisole
(BHA) and butylated hydroxytoluene (BHT) as antioxidants. Calcitriol
oral solution contains caprylic
triglycerides. 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 D3, 1,25-DHCC, 1,25(OH)2D3 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 D3
(cholecalciferol). Vitamin D3 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 D3 is catalyzed by a
vitamin D3-25-hydroxylase enzyme (25-OHase) present in the liver, and
the product of this reaction is
25-hydroxyvitamin D3 [25-(OH)D3]. Hydroxylation of 25-(OH)D3 occurs in
the mitochondria of kidney
tissue, activated by the renal 25-hydroxyvitamin D3-1
alpha-hydroxylase (alpha-OHase), to produce
1,25-(OH)2D3 (calcitriol), the active form of vitamin D3. Endogenous
synthesis and catabolism of
calcitriol, as well as physiological control mechanisms affecting
these processes, play a critical role
regulating the serum level of calcitriol. Physiological d