CALCITRIOL capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva 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. C

Product summary:

Calcitriol capsules are available as follows: 0.25 mcg - opaque, red-brown and yellow-brown, two-tone, oval, soft, gelatin capsules, imprinted “93” and “657”, in bottles of 100 (NDC 0093-7352-01). 0.5 mcg - opaque, brown and pink, two-tone, oblong, soft, gelatin capsules, imprinted “93” and “658”, in bottles of 100 (NDC 0093-7353-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCITRIOL- CALCITRIOL CAPSULE, LIQUID FILLED
TEVA PHARMACEUTICALS USA, INC.
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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. It is
available as capsules containing 0.25
mcg or 0.5 mcg calcitriol. Each capsule also contains the following
inactive ingredients: butylated
hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as
antioxidants, and triglycerides (medium
chain). Gelatin capsule shell contains gelatin, glycerol, mannitol,
red iron oxide, sorbitanhydrides,
sorbitol, superior polyols, titanium dioxide and yellow iron oxide.
Imprinting ink contains propylene
glycol, shellac modified, and titanium dioxide.
Calcitriol is a white, crystalline compound which occurs naturally in
humans. It 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:
C
H O M.W. 416.65
The other names frequently used for calcitriol 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 . Endogeno