Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CALCIPOTRIENE HYDRATE (UNII: S7499TYY6G) (CALCIPOTRIENE - UNII:143NQ3779B)
Akorn
CALCIPOTRIENE HYDRATE
CALCIPOTRIENE 0.05 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
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.
Calcipotriene Topical Solution, 0.005% (Scalp Solution), is available in 60 mL plastic bottles. NDC 50383-732-02
Abbreviated New Drug Application
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 Olvassa el a teljes dokumentumot