ROCALTROL- calcitriol capsule, gelatin coated ROCALTROL- calcitriol solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Validus Pharmaceuticals LLC

Designación común internacional (DCI):

CALCITRIOL

Composición:

CALCITRIOL 0.25 ug

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 30698-143-23), and bottles of 100 (NDC 30698-143-01). Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 30698-144-01). 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 30698-911-15). Rocaltrol 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 USP.

Estado de Autorización:

New Drug Application

Ficha técnica

ROCALTROL- CALCITRIOL CAPSULE, GELATIN COATED
ROCALTROL- CALCITRIOL SOLUTION
VALIDUS PHARMACEUTICALS LLC
----------
ROCALTROL
ROCALTROL
brand of
(Calcitriol)
CAPSULES AND ORAL SOLUTION
RX ONLY
DESCRIPTION
Rocaltrol (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.
Rocaltrol 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-
®
3
2
3
3
3
transformation of vitamin D is catalyzed by