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2008年10月23日，美国FDA批准Dow Pharmaceutical Sciences，Inc公司的1．2％克林霉素磷酸酯＋2.5％过氧化苯甲酰复方凝胶（Acanya TM）用于治疗≥12岁的寻常型痤疮患者。
本品为目前FDA批准的唯一过氧化苯甲酰与抗菌药物的复方制剂,既可用于非炎性痤疮也可用于炎性痤疮的治疗.
ACANYA（克林霉素磷酸盐/过氧化苯甲酰[clindamycin phosphate and benzoyl peroxide]）凝胶 1.2％/2.5％，用于局部使用
初始美国批准：2000
作用机制
克林霉素：克林霉素是林可酰胺抗菌剂[参见Microbiology（12.4）]。
过氧化苯甲酰：过氧化苯甲酰是一种具有杀菌和角质溶解作用的氧化剂，但其作用机理尚不清楚。
适应症和用法
ACANYA凝胶是一种林可酰胺抗生素，过氧化苯甲酰表明用于局部治疗寻常痤疮。
剂量和给药
•每天向脸上涂一粒豌豆大小的ACANYA凝胶。
•不适用于口服，眼部或阴道内使用。
剂量形式和强度
ACANYA凝胶在50克泵中的外用凝胶中含有1.2％的克林霉素磷酸盐和2.5％的过氧化苯甲酰。
禁忌症
ACANYA凝胶是禁忌：
•已经证明对克林霉素，过氧化苯甲酰，制剂的任何组分或林可霉素过敏（例如，过敏）的患者。
•患有局部肠炎，溃疡性结肠炎或抗生素相关性结肠炎病史的患者。
警告和注意事项
•结肠炎：口服和胃肠外施用的克林霉素与严重的结肠炎有关，可能导致死亡。已经报道了使用局部和全身性克林霉素的腹泻，血性腹泻和结肠炎（包括假膜性结肠炎）。如果出现明显的腹泻，应停止使用ACANYA凝
•紫外线和环境暴露：在药物应用后尽量减少阳光照射。
不良反应
以下选择的不良反应发生在小于0.2％的患者中：施用部位疼痛（0.1％）;应用部位剥落（0.1％）;和应用部位刺激（0.1％）。
药物相互作用
•ACANYA凝胶不应与含红霉素的产品组合使用，因为其含有克林霉素组分。
供应/存储和处理
如何提供ACANYA凝胶作为50g泵（NDC 13548-132-50）供应。
药剂师的点胶说明
•分配ACANYA凝胶，10周有效期。
•指定“在室温下储存至25°C（77°F），不要冻结。
存储和处理•
药物：分配前：储存在2°C至8°C（36°F至46°F）的冰箱中。
•患者：在室温下保存在或低于25°C（77°F）。
•防止冻结。
• 放在儿童接触不到的地方。
•保持容器密闭。
完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3dcd2c96-72b1-4a9f-b65c-08198d63b7df
ACANYA ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%
INDICATION
ACANYA (clindamycin phosphate and benzoyl peroxide) GEL, 1.2%/2.5% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years and older.
Do not get ACANYA GEL in your mouth, eyes, or vagina, or on your lips. It is not known whether ACANYA GEL is safe and effective for use longer than 12 weeks, or in children under 12 years of age.
IMPORTANT SAFETY INFORMATION
Do not use ACANYA GEL if you have: Crohn’s disease, ulcerative colitis, had inflammation of the colon (colitis) or severe diarrhea with past antibiotic use. Talk with your doctor if you are not sure if you have one of these conditions.
ACANYA GEL can cause serious side effects including:
•Inflammation of the colon (colitis). Stop using ACANYA GEL and call your doctor right away if you have severe watery diarrhea, or bloody diarrhea.
•Allergic reactions. Stop using ACANYA GEL, call your doctor and get help right away if you have any of the following symptoms: severe itching; swelling of your face, eyes, lips, tongue or throat; or trouble breathing.
Common side effects with ACANYA GEL include skin irritation. Stop using ACANYA GEL and call your doctor if you have a skin rash or your skin becomes very red, itchy or swollen. Talk to your doctor about any side effect that bothers you or that does not go away.
Tell your doctor about all the medicines and skin products you use.
Especially tell your doctor if you will have surgery with general anesthesia. One of the medicines in ACANYA GEL (clindamycin) can affect how certain medicines work when used in general anesthesia.
•ACANYA GEL should not be used with products that contain erythromycin.
•Other skin and topical acne products may increase the irritation of your skin when used with ACANYA GEL.
Sun Protection
When using ACANYA GEL, limit your time in sunlight. Avoid using tanning beds or sun lamps. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and a sunscreen with SPF 15 rating or higher.
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