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  药店国别: 美国药房
产地国家: 美国
所属类别: 皮肤科药物->治疗痤疮药物
处方药:处方药
包装规格: 50克/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
DOW PHARM SCI
生产厂家英文名:
DOW PHARM SCI
该药品相关信息网址1:
http://www.acanyagel.com/
该药品相关信息网址2:
www.drugs.com/acanya.html
原产地英文商品名:
ACANYA GEL 50G/BOTTLE
原产地英文药品名:
CLINDAMYCIN PHOSPHATE 1.2%/BENZOYL PEROXIDE 2.5%
中文参考商品译名:
ACANYA凝胶 50克/瓶
中文参考药品译名:
克林霉素磷酸酯1.2%/过氧化苯甲酰2.5%
原产地国家批准上市年份:
2008/10/21
英文适应病症1:
Acne
临床试验期:
完成
中文适应病症参考翻译1:
痤疮
药品信息:

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 详细处方信息以本药内容附件PDF文件(20126519315535.PDF)的“原文Priscribing Information”为准
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 部分中文Acanya处方资料(仅供参考)

美国FDA批准Arcutis Pharma 公司的Acanya 凝胶用于痤疮的治疗
    一家私立的专业皮肤科产品研究机构Arcutis 制药公司 于2008年11月24日对外宣布,美国FDA 已批准该其1.2%克林霉素磷酸酯+2.5%过氧化苯甲酰复方凝胶(clindamycin phosphate + benzoyl peroxide,Acanya)用于年龄在12岁及以上寻常型痤疮患者的新药申请。

  本品的临床研究共纳入超过3200例中到重度痤疮患者。本品为目前FDA 唯一批准的过氧化苯甲酰与抗菌药物的复方产品,既可用于非炎性痤疮患者也可用于炎性痤疮患者,用法为每日1次。

  Arcutis 制药的CEO Bhaskar Chaudhuri 在对外发表声明时称:

  “我们非常高兴Acanya 凝胶获得了FDA的批准。本品采用亲水性基质,是一种无酒精的产品。而该优化的制剂技术提高了过氧化苯甲酰的生物利用度,为痤疮患者提供了一个有效且耐受性良好的产品。在关键性临床研究中,本品与空白基质、单独使用过氧化苯甲酰、单独使用克林霉素磷酸酯相比显示出了更优越的协同效应。而且本品的耐受性良好,没有皮肤出现干燥情况的报道。”

  本品出现不良反应的几率低于0.2%,包括使用部位出现疼痛(0.1%)、使用部位出现表皮剥脱(0.1%)及使用部位出现刺激性(0.1%)等。寻常型痤疮是一种常见的皮肤疾病,大约会影响到85%的人群,在他们一生中的某一阶段。

  在2007年,大约有500万例痤疮患者由于该疾病就诊,根据Verispan和IMS的数据,大约有170万例的处方是用于治疗痤疮的。本品受2个美国专利的保护,而且还有一些专利正在审查中。

  Arcutis 是一家专注于皮肤领域的专科药物研发机构,其目标是优化处方药以便使患者乐于使用。

Talk to your doctor about the right acne medication for you
The more you know about your acne, the better your doctor will be able to help you with treatment. Below are questions to help with your discussion. Before using Acanya Gel, be sure to read the patient information and application instructions. Tell your doctor immediately about any side effect that bothers you or that does not go away.

What type of acne do I have?
Acanya Gel is approved to treat mild, moderate, and severe acne. This can include:
—Noninflammatory acne (blackheads and whiteheads)
—Inflammatory acne (pimples and pustules)

How often will I need to use my acne medication?
Acanya Gel is applied once a day.

How long does it take before I see results?
Each individual is different, but in clinical studies the number of acne lesions was significantly reduced by 12 weeks in patients using Acanya Gel once daily.

Will my acne medication irritate my skin?
Acanya Gel is water based, with no alcohol or detergents that may sting or burn your skin. In clinical studies, infrequent side effects seen were itching, burning, stinging, redness, or flaking skin. However, no patients stopped using Acanya Gel due to these side effects.

Can I wear makeup or sunscreen with my acne medication?
Skin treated with Acanya Gel should be protected from sunlight. Ask your doctor about the proper use of sunscreens, moisturizers, and cosmetics with Acanya Gel.

Indication and Important Safety Information:
Acanya Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. Do not use Acanya Gel if you are allergic to clindamycin, have Crohn's disease, ulcerative colitis or have developed inflammation of the colon (colitis) with past antibiotic use. Clindamycin, the antibiotic in Acanya Gel, may cause diarrhea. If you experience severe diarrhea, bloody diarrhea, or severe abdominal cramping stop using Acanya Gel immediately and contact your doctor. Clindamycin taken orally or through IV may result in severe colitis, which may result in death. If you develop allergic symptoms such as severe itching, swelling of the face, eyes, lips, tongue or throat, or trouble breathing, you should stop using Acanya Gel and contact your doctor immediately. Limit your time in sunlight after applying Acanya Gel and avoid using tanning beds or sun lamps. Acanya Gel is for topical use only. Avoid applying Acanya Gel in mouth, eyes, or nose or on lips. Side effects may include redness, scaling, itching, burning, and stinging.

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 详细处方信息以本药内容附件PDF文件(20126519315535.PDF)的“原文Priscribing Information”为准
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更新日期: 2012-6-6
附件:






20126519315535.PDF    

 
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