英文药名：VIAGRA OD Film（Sildenafil Citrate） 中文药名：枸橼酸西地那非口腔崩解薄膜片 生产厂家：辉瑞制药 バイアグラODフィルム25mg/バイアグラODフィルム50mg 药物分类名称 治疗勃起功能障碍 商標名 VIAGRA Tablets VIAGRA OD Film 一般名 シルデナフィルクエン酸塩（Sildenafil Citrate） 化学名 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine monocitrate 分子式 C22H30N6O4S・C6H8O7 分子量 666.70 構造式 性状 西地那非柠檬酸盐是白色结晶性粉末。 易溶于N，N-二甲基乙酰胺，难溶于水或甲醇，难溶于乙腈，乙醇（95）或乙醚。 药效药理 1. PDE5阻害作用 选择性地和竞争性地抑制人海绵体cGMP降解酶PDE5的活性（IC50值：3.5nmol/L） 2. 海绵体cGMP在cGMP中的作用增加 与NO供体组合使用，硝普钠（SNP）增加了切除的兔子海绵体中cGMP的含量，而不影响cAMP水平（EC50值：0.43〜0.52μmol/L） 3. 增强海绵身体的作用 切除的人体海绵体的透壁神经刺激的松弛反应在10nmol/L以上增强，弛豫反应的持续时间延长至100nmol/L以上。 此外，通过作用于SNP和海绵体内皮细胞释放NO的mesocorin分离的兔海绵体的松弛反应增强10nmol/L以上。 4.海綿体内圧増強作用 （ED 50值：12.0μg/ kg神经刺激，16.2μg/ kg SNP;静脉内施用），不影响血压和心率，骨盆神经刺激和SNP麻醉狗海绵体内压升高 适应病症 勃起功能障碍（不能承受勃起足以进行令人满意的性活动而不能维持的患者） 用法与用量 成年人，在性活动前约1小时，每天口服25mg至50mg。 对于老年人（65岁以上），肝功能障碍患者和重度肾损伤患者（Ccr <30mL/min），由于认识到该药物的血浆浓度增加，25mg 应该是起始剂量。 每日给药一次，给药间隔应为24小时以上。 包装规格 片 25mg：10片（PTP）×2 50mg：10片（PTP）×2,10片（PTP）×10 OD薄膜片 25mg：20张（10张×2） 50mg：20张（10张×2），50张（10张×5） 制造销售 辉瑞公司 完整说明书附件：http://www.info.pmda.go.jp/go/pack/259000AF1024_2_13/ New formulation of erectile dysfunction treatment agent "Viagra ®" "Viagra® OD film" New release on October 21 ~ "First domestic" OD film formulation as ED therapeutic agent ~ On October 21, 2016, Pfizer Inc. (Headquarters: Shibuya-ku, Tokyo, President: Ichiro Umeda) announced on October 21, 2016 that a new agent for the treatment of erectile dysfunction "Viagra®" (generic name: sildenafil citrate) "Viagra OD film 25 mg · 50 mg same" was released. Viagra has been approved in the world as the world's first erectile dysfunction treatment in 130 countries, and in Japan since 1999 it has started selling "Viagra tablets 25 mg · same 50 mg". "Viagra OD Film" which we released this time is the first OD film formulation in Japan as a therapeutic agent for erectile dysfunction, has the feature that it melts promptly in the oral cavity and can be taken without water, It is expected to take. In addition, this product is a formulation enclosed in thin aluminum packaging, which is expected to improve portability compared with conventional tablets. In the survey of attitudes towards ED patients conducted with Pfizer, about 60% of patients have revealed the fact that they carry ED therapeutic agents in their regularly used bags. Therefore, we believe that this drug will also be useful for such patients. As stated above, this drug improved in compliance and portability will contribute further to improving the patient's quality of life. Viagra OD film product overview Product name Viagra® OD film 25 mg · same 50mg common name Sildenafil citrate Indication Erectile dysfunction (patients who can not afford erection sufficient to perform satisfactory sexual activity and can not maintain it) Dosage regimen Usually, adults orally administer 25mg to 50mg of sildenafil once a day about 1 hour before sexual activity. For patients aged 65 years and older, patients with hepatic impairment and patients with severe renal impairment (Ccr<30 mL/min), it is recognized that the plasma concentration of this drug is increased, so 25 mg should be the starting dose. Daily administration should be done once, the dosing interval should be 24 hours or more.