CALCITRIOL- calcitriol capsules 0.25 mcg capsule CALCITRIOL- calcitriol capsules 0.5 mcg capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Strides Pharma Science Limited

INN (International Name):

CALCITRIOL

Composition:

CALCITRIOL 0.25 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcitriol capsule 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 capsule 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 capsule is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseu

Product summary:

Capsules : 0.25 mcg calcitriol in soft gelatin, orange, oval capsules, imprinted with 673; bottles of 30 (64380-723-04), and bottles of 100 (64380-723-06). Capsules : 0.5 mcg calcitriol in soft gelatin, orange, oblong capsules, imprinted with 674; bottles of 100 (64380-724-06).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCITRIOL - CALCITRIOL CAPSULES 0.25 MCG CAPSULE
STRIDES PHARMA SCIENCE LIMITED
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CALCITRIOL CAPSULES (0.25 MCG AND 0.5 MCG)
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 All
dosage forms contain
butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as
antioxidants.
The capsules contain medium chain triglycerides. Gelatin capsule
shells contain glycerin,
sorbitol, with the following dye systems: 0.25-mcg FD&C Yellow No. 6,
FD&C red No.3
and titanium dioxide; 0.5 mcg- FD&C Yellow No. 6, FD&C red No.3 and
titanium dioxide.
The imprinting ink contains propylene glycol, shellac, black iron
oxide, isopropyl alcohol,
N-butyl alcohol and ammonium hydroxide.
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:
CALCITRIOL
The other names frequently used for calcitriol are
lα,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