CALCIPOTRIENE solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

CALCIPOTRIENE HYDRATE (UNII: S7499TYY6G) (CALCIPOTRIENE - UNII:143NQ3779B)

Pieejams no:

Akorn

SNN (starptautisko nepatentēto nosaukumu):

CALCIPOTRIENE HYDRATE

Kompozīcija:

CALCIPOTRIENE 0.05 mg in 1 mL

Ievadīšanas:

TOPICAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.

Produktu pārskats:

Calcipotriene Topical Solution, 0.005% (Scalp Solution), is available in 60 mL plastic bottles. NDC 50383-732-02

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

CALCIPOTRIENE- CALCIPOTRIENE SOLUTION
AKORN
----------
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 clear,
colorless to light yellow
topical solution containing calcipotriene monohydrate, a synthetic
vitamin D derivative,
for topical dermatologic use.
The chemical name of calcipotriene monohydrate is (5Z, 7E, 22E,
24S)-24-cyclopropyl-
9,10-secochola-5,7,10(19), 22-tetraene-1α,3β, 24-triol monohydrate,
with the empirical
formula C
H
O ●H O, a molecular weight of 430.6, and the following structural
formula:
Calcipotriene monohydrate is a white or off-white crystalline
substance. Calcipotriene
Topical Solution, 0.005% (Scalp Solution) contains calcipotriene
monohydrate equivalent
to 50 μg/g anhydrous calcipotriene in a vehicle of hydroxypropyl
cellulose, isopropyl
alcohol (51% v/v), menthol, propylene glycol, purified water, and
sodium citrate.
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
3
27
40
3
2
3
3
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 t