CALCIPOTRIENE solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

calcipotriene (UNII: 143NQ3779B) (calcipotriene - UNII:143NQ3779B)

可用日期:

Fougera Pharmaceuticals Inc.

INN（国际名称）:

calcipotriene

组成:

calcipotriene 0.05 mg in 1 mL

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Calcipotriene Topical Solution 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. Calcipotriene Topical Solution 0.005% (Scalp Solution) is contraindicated in those patients with acute psoriatic eruptions or a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity.

產品總結:

Calcipotriene Topical Solution 0.005% (Scalp Solution) is available in: 60 mL plastic bottles NDC 0168-0400-60

授权状态:

Abbreviated New Drug Application

产品特点

CALCIPOTRIENE- CALCIPOTRIENE SOLUTION
FOUGERA PHARMACEUTICALS INC.
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CALCIPOTRIENE TOPICAL SOLUTION 0.005%
(SCALP SOLUTION)
FOR TOPICAL DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
RX ONLY
DESCRIPTION:
Calcipotriene Topical Solution 0.005% (Scalp Solution) is a colorless
topical solution containing
0.005% calcipotriene (anhydrous), a synthetic vitamin D derivative,
for topical dermatologic use. The
chemical name of calcipotriene is (5Z,7E,22E,24S)-24
cyclopropyl-9,10-secochola-5,7,10(19),22-
tetraene-1α,3β,24-triol, with the empirical formula C
H O , a molecular weight of 412.6, and the
following structural formula:
Calcipotriene is a white to off-white powder substance. Calcipotriene
topical solution contains
calcipotriene (anhydrous) 50μg/g in a vehicle of isopropanol (51%
v/v), propylene glycol,
hydroxypropyl cellulose, sodium citrate (anhydrous), menthol and
water.
CLINICAL PHARMACOLOGY:
In humans, the natural supply of vitamin D depends mainly on exposure
to the ultraviolet rays of the sun
for conversion of 7-dehydrocholesterol to vitamin D (cholecalciferol)
in the skin. Calcipotriene is a
synthetic analog of vitamin D .
Although the precise mechanism of calcipotriene's antipsoriatic action
is not fully understood, _in vitro_
evidence suggests that calcipotriene is roughly equipotent to the
natural vitamin in its effects on
proliferation and differentiation of a variety of cell types.
Calcipotriene has also been shown, in animal
studies, to be 100-200 times less potent in its effects on calcium
utilization than the natural hormone.
Clinical studies with radiolabelled calcipotriene solution indicate
that less than 1% of the applied dose
of calcipotriene is absorbed through the scalp when the solution (2.0
mL) is applied topically to normal
skin or psoriasis plaques (160 cm ) for 12 hours, and that much of the
absorbed calcipotriene is
converted to inactive metabolites within 24 hours of application.
Vitamin D and its metabolites are
transported in the blood, bound to specif