CALCITRIOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

CALCITRIOL

Composition:

CALCITRIOL 0.25 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Predialysis Patients Calcitriol capsules re 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 capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules 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 capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. Calcitriol, USP should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of calcitriol capsules in patients with known hypersensitivity to calcitriol, USP (or drugs of the same class) or any of the inactive ingredients is contraindicated.

Product summary:

Calcitriol Capsules 0.25 mcg are supplied as opaque orange color, oval shaped capsules, imprinted with “A19”. They are available as follows: Bottles of 30:                              NDC 65162-519-03 Bottles of 100:                            NDC 65162-519-10 Bottles of 250:                            NDC 65162-519-25 Calcitriol Capsules 0.5 mcg are supplied as opaque orange color, oblong capsules, imprinted with “A76”. They are available as follows: Bottles of 30:                              NDC 65162-576-03 Bottles of 100:                            NDC 65162-576-10 Bottles of 250:                            NDC 65162-576-25 Calcitriol Capsules should be protected from light. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. REFERENCE 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: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 11-2015-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCITRIOL- CALCITRIOL CAPSULE
AMNEAL PHARMACEUTICALS LLC
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CALCITRIOL CAPSULES
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 as containing either 0.25 mcg or 0.5 mcg calcitriol,
USP. Calcitriol capsules
contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene
(BHT) as
antioxidants. The capsules also contain medium chain triglycerides.
Gelatin capsule shells
contain FD&C Yellow No. 6, gelatin, glycerin, methyl paraben sodium,
propyl paraben
sodium, purified water, and titanium dioxide. The 0.5 mcg capsules
also contain FD&C
Red No. 40.
Calcitriol, USP 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, 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-
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 calcit