近日，美国FDA批准ACANYA(clindamycin phosphate and benzoyl peroxide Gel, 1.2%/2.5%)用于年龄在12岁及以上寻常型痤疮患者的新药。
本品是唯一获FDA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。
批准日期：2008年11月24日 公司：DOW PHARM SCI 
ACANYA（克林霉素磷酸酯和过氧化苯甲酰[clindamycin phosphate and benzoyl peroxide]）凝胶，1.2％/2.5％，用于局部使用
初始美国批准：2000年
作用机制
克林霉素：克林霉素是一种林可酰胺抗菌剂[见临床药理学]。
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，但其确切的作用机制尚不清楚。
适应症和用法
ACANYA凝胶是一种林可酰胺抗生素和过氧化苯甲酰，适用于局部治疗寻常痤疮。
剂量和用量
•每天一次在脸上涂上豌豆大小的ACANYA凝胶。
•不适用于口服，眼科或阴道内使用。
剂量形式和强度
ACANYA凝胶在50克泵中的局部凝胶中含有1.2％的克林霉素磷酸酯和2.5％的过氧化苯甲酰。
禁忌症
ACANYA凝胶禁用于：
已证实对克林霉素，过氧化苯甲酰，制剂的任何组分或林可霉素过敏（例如，过敏反应）的患者。
•有区域性肠炎，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：口服和肠胃外给药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克林霉素的腹泻，血性腹泻和结肠炎（包括伪膜性结肠炎）。如果出现严重腹泻，应停用ACANYA凝胶。
•紫外线和环境暴露：药物应用后最大限度地减少阳光照射。
不良反应
0.2％的患者：应用部位疼痛（0.1％）;应用部位去角质（0.1％）;和应用场所刺激（0.1％）。
药物相互作用
•由于其克林霉素成分，ACANYA凝胶不应与含红霉素的产品联合使用。
包装提供/存储和处理
提供
ACANYA凝胶以50g泵（NDC 13548-132-50）供应。
药剂师的配药说明
•分配ACANYA凝胶，有效期为10周。
•指定“在室温下储存至25°C（77°F）。不要冻结。”
存储和处理
•药剂师：分配前：储存在2°C至8°C（36°F至46°F）的冰箱中。
•患者：室温保存在25°C（77°F）或以下。
•防止冻结。
•勿让儿童接触。
•保持容器密闭。
ACANYA (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%
Description
ACANYA (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.
The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galactooctopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below:
Indications
ACANYA® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
How supplied
Dosage Forms And Strengths
Gel, 1.2%/2.5%
Each gram of ACANYA Gel contains 10 mg (1%) clindamycin as phosphate, and 25 mg (2.5%) benzoyl peroxide in a white to off-white, opaque, smooth gel.
ACANYA Gel is supplied as a 50 g pump (NDC 13548-132-50).
Dispensing Instructions For The Pharmacist
Dispense ACANYA Gel with a 10 week expiration date.
Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”
Side effects
Clinical Trials Experience
Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following selected adverse reactions occurred in less than 0.2% of patients treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%).
During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around week 4 and continually decreased over time reaching near baseline levels by week 12. The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at week 12 are shown in Table.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3dcd2c96-72b1-4a9f-b65c-08198d63b7df