CALCITRIOL solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

CALCITRIOL

Composition:

CALCITRIOL 1 ug in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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. Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. Cal

Product summary:

Calcitriol Oral Solution 1 mcg/mL oral solution is supplied as a clear, pale yellow solution. Each 15 mL amber glass bottle is supplied with 20 single-use, graduated oral dispensers. NDC 0054-3120-41: Bottle of 15 mL Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCITRIOL- CALCITRIOL SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
CALCITRIOL ORAL SOLUTION
RX ONLY
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 is available as an oral solution, for oral
administration, containing 1
mcg/mL of calcitriol, USP. Calcitriol Oral Solution contains butylated
hydroxyanisole
(BHA), butylated hydroxytoluene (BHT), and medium chain triglycerides.
Calcitriol, USP is a white to almost white crystal which occurs
naturally in humans. It has
a calculated molecular weight of 416.6 and is soluble in organic
solvents but practically
insoluble in water. Chemically, calcitriol, USP is
9,10-seco(5Z,7E)-5,7,10(19)-
cholestatriene-1α, 3β, 25-triol and has the following structural
formula:
C
H
O
The other names frequently used for calcitriol, USP 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
processes, play a critical role regulating the serum level of
calcitriol. Physiological daily
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