

FINACEA GEL 壬二酸外用凝胶

通用中文 | 壬二酸外用凝胶 | 通用外文 | AZELAIC ACID |
品牌中文 | 非娜丝 | 品牌外文 | FINACEA GEL |
其他名称 | |||
公司 | 拜耳(Bayer) | 产地 | 美国(USA) |
含量 | 15% .50mg | 包装 | 10支/盒 |
剂型给药 | 储存 | 室温 | |
适用范围 | 轻、中度酒渣鼻的局部炎症性丘疹和脓疱 |
通用中文 | 壬二酸外用凝胶 |
通用外文 | AZELAIC ACID |
品牌中文 | 非娜丝 |
品牌外文 | FINACEA GEL |
其他名称 | |
公司 | 拜耳(Bayer) |
产地 | 美国(USA) |
含量 | 15% .50mg |
包装 | 10支/盒 |
剂型给药 | |
储存 | 室温 |
适用范围 | 轻、中度酒渣鼻的局部炎症性丘疹和脓疱 |
简介:
部份中文FINACEA处方资料(仅供参考)
商品名: FINACEA
成分品名: AZELAIC ACID
中文译名: 非娜丝
Finacea(壬二酸)已经被FDA批准可以治疗轻、中度酒渣鼻的局部炎症性丘疹和脓疱。试验结果表明,Finacea能明显减少酒渣鼻引起的炎症性丘疹和脓疱的数量,治疗4周就可见到效果,且在以后8周内效果还不断加强。
Finacea含壬二酸,一种天然饱和二羧酸,是无色、无味的晶状物,不易在水中溶解,但能溶于酒精。Finacea的凝胶配方与膏状配方相比,渗透性更好。临床试验表明它能干扰酒渣鼻的致病因子,体外试验也发现有抗炎效应。
适应症:
轻、中度酒渣鼻的局部炎症性丘疹和脓疱。
禁忌症:
有对丙二醇或本配方中的其它任何成份过敏史者慎用本药,它报告得最多的副作用有烧灼感/麻刺感和发痒,见于10%的病人。还有1-10%的病人皮肤发干,有皮疹。多数副作用均很轻微。
简介:
部份中文FINACEA处方资料(仅供参考)
商品名: FINACEA
成分品名: AZELAIC ACID
中文译名: 非娜丝
Finacea(壬二酸)已经被FDA批准可以治疗轻、中度酒渣鼻的局部炎症性丘疹和脓疱。试验结果表明,Finacea能明显减少酒渣鼻引起的炎症性丘疹和脓疱的数量,治疗4周就可见到效果,且在以后8周内效果还不断加强。
Finacea含壬二酸,一种天然饱和二羧酸,是无色、无味的晶状物,不易在水中溶解,但能溶于酒精。Finacea的凝胶配方与膏状配方相比,渗透性更好。临床试验表明它能干扰酒渣鼻的致病因子,体外试验也发现有抗炎效应。
适应症:
轻、中度酒渣鼻的局部炎症性丘疹和脓疱。
禁忌症:
有对丙二醇或本配方中的其它任何成份过敏史者慎用本药,它报告得最多的副作用有烧灼感/麻刺感和发痒,见于10%的病人。还有1-10%的病人皮肤发干,有皮疹。多数副作用均很轻微。
Finacea (azelaic acid) topical Gel, 15%
General Information
Finacea (azelaic acid 15%) is a topical gel indicated for the treatment of inflammatory papules and pustules of mild to moderate rosacea. The gel formulation of Finacea provides improved drug penetration compared with the cream formulation.
Finacea is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.
Clinical Results
The approval of Finacea Gel, 15%, for the treatment of mild to moderate papulopustular rosacea, was based on 2 clinical trials comprising a total of 664 (333 active to 331 vehicle) subjects. The primary efficacy endpoints were change from baseline in inflammatory lesion counts and the treatment success, defined as a score of clear or minimal with at least a 2-step reduction from baseline. Scores were assessed on the Investigator’s Global Assessment (IGA) scale.
Both multicenter, randomized, double blind, and vehicle-controlled studies demonstrated a statistically significant difference in reducing the number of inflammatory papules and pustules associated with rosacea. Data showed that Finacea resulted in a higher treatment score compared to its vehicle. Both trials were 12-week studies with identical protocols.
Side Effects
Adverse events associated with the use of Finacea may include (but are not limited to) the following:
•Burning and Stinging
•Pruritus
•Scaling/Dry Skin/Xerosis
•Edema
•Acne
•Seborrhea
•Photosensitivity
•Skin Disease
Mechanism of Action
Finacea (azelaic acid) Gel, 15%, contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Azelaic acid is a white, odorless crystalline solid that is poorly soluble in water, but well soluble in alcohol. The mechanism by which azelaic acid interferes with the pathogenic events in rosacea is unknown, but an anti-inflammatory effect was found in vitro.
Azelaic acid is mainly excreted unchanged in the urine, but undergoes some ß-oxidation to shorter chain dicarboxylic acids.