rocaltrol- calcitriol capsule, liquid filled rocaltrol- calcitriol solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

calcitriol (UNII: FXC9231JVH) (calcitriol - UNII:FXC9231JVH)

Beszerezhető a:

Roche Pharmaceuticals

INN (nemzetközi neve):

calcitriol

Gyógyszerészeti forma:

CAPSULE, LIQUID FILLED

Összetétel:

0.25 ug

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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. 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. Rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism. Rocalt

Termék összefoglaló:

Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with ROCALTROL 0.25 ROCHE; bottles of 30 (NDC 0004-0143-23), and bottles of 100 (NDC 0004-0143-01). Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with ROCALTROL 0.5 ROCHE; bottles of 100 (NDC 0004-0144-01). 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 0004-9115-00). Rocaltrol Capsules and Oral Solution should be protected from light . Store at 59° to 86°F (15° to 30°C).

Termékjellemzők

ROCALTROL- CALCITRIOL CAPSULE, LIQUID FILLED
ROCALTROL- CALCITRIOL SOLUTION
ROCHE PHARMACEUTICALS
----------
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,
parabens (methyl and propyl) 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 produc