CALCITRIOL capsule CALCITRIOL solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

CALCITRIOL

Composition:

CALCITRIOL 0.25 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Predialysis Patients 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. Dialysis Patients 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. Hypoparathyroidism Patients Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidi

Product summary:

Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01). Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01). Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59). Calcitriol Capsules and Oral Solution should be protected from light. Store at 59° to 86°F (15° to 30°C). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CALCITRIOL- CALCITRIOL CAPSULE
CALCITRIOL- CALCITRIOL SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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CALCITRIOL CAPSULES AND ORAL SOLUTION
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 and as an oral solution
containing 1 mcg/mL of calcitriol. All
dosage forms contain butylated hydroxyanisole (BHA) and butylated
hydroxytoluene (BHT) as
antioxidants. The capsules contain a fractionated triglyceride of
coconut oil, and the oral solution
contains a fractionated triglyceride of palm seed oil. Gelatin capsule
shells contain glycerin, and
sorbitol, with the following dye systems: 0.25 mcg — FD&C Yellow No.
6 and titanium dioxide; 0.5
mcg — FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide. The
oral solution contains no
additional adjuvants or coloring principles.
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:
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 ]. H