CALCITRIOL capsule

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 0.25 ug

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. Calcitriol capsules should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of calcitriol in patients with known hypersensitivity to calcitriol (or drugs of the same class) or any of the inactive ingredients is contraindicated.

Product summary:

Calcitriol Capsules 0.25 mcg capsules are supplied as yellow, oval soft gelatin capsules, imprinted with “547” in black ink. NDC 0054-0007-13: Bottle of 30 Capsules NDC 0054-0007-25: Bottle of 100 Capsules Calcitriol Capsules should be protected from light. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCITRIOL- CALCITRIOL CAPSULE
HIKMA PHARMACEUTICALS USA INC.
----------
CALCITRIOL CAPSULES
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
are available containing 0.25 mcg of calcitriol, USP. Calcitriol
capsules contain butylated
hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as
antioxidants. The capsules
contain a fractionated triglyceride of coconut oil. Gelatin capsule
shells contain gelatin,
glycerin (anhydrous), and titanium dioxide, with the following dyes:
FD&C Yellow No. 5
and FD&C Yellow No. 6. In addition to the ingredients listed above,
each capsule contains
Opacode (Black) monogramming ink. Opacode (Black) contains ammonium
hydroxide,
iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate
phthalate, propylene
glycol, purified water and SDA 35A alcohol.
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:
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-
C
H
O
27
44
3
3
2
3
3
3
3
3
OHase) present in the liver, and the product of this reaction is
25-hydroxyvitamin D
[25-(OH)D ]. Hydroxy