部份中文枸橼酸西地那非处方资料（仅供参考）
英文名：Sildenafil Citrate
商品名：Viagra OD film
中文名：枸橼酸西地那非薄膜片
生产商：Viatris Pharmaceutical
药品简介
2016年10月，辉瑞研发的新剂型类VIAGRA® OD Film（Sildenafil Citrate 20mg、25mg、50mg）在日本推出。该品种基于溶解膜技术开发治疗勃起功能障碍速效药，该产品类似口香糖胶片，无需经胃液，只需轻含在口中，膜剂即会溶解，通过舌头毛细血管吸收。
勃起功能障碍（erectile dysfunction，ED）是一种男性性功能障碍，指阴茎持续不能达到或维持足够的勃起以完成满意性生活，病程3个月以上。
バイアグラ錠25mg/バイアグラ錠50mg/バイアグラODフィルム25mg/バイアグラODフィルム50mg
药效分类名称
勃起功能障碍治疗
批准日期：2016年10月
商標名
VIAGRA Tablets
VIAGRA OD Film
一般的名称
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
性状
枸橼酸西地那非为白色结晶性粉末。它易溶于 N,N-二甲基乙酰胺，微溶于水或甲醇，几乎不溶于乙腈、乙醇 (95) 或乙醚。
化学構造式
药效药理
作用机制
西地那非通过选择性抑制海绵体内的PDE5，抑制神经和海绵体NO刺激产生的海绵体内cGMP降解，使海绵体平滑肌松弛，增加血流量，使阴茎勃起和维持。
PDE5抑制作用
它选择性和竞争性地抑制人阴茎海绵体中的cGMP降解酶PDE5的活性（IC50值：3.5nmol/L）。
阴茎海绵中的cGMP增加与NO供体硝普钠（SNP）合用时，在不影响cAMP量的情况下，取出兔的海绵中cGMP的量有所增加（EC50值：0.43～0.52μmol/L）。
海绵体松弛增强效果
经壁神经刺激对切除的人海绵体的松弛反应在10nmol/L或更高时增强，在100nmol/L或更高时松弛反应的持续时间延长。此外，在10 nmol/L或更高时，作用于SNPs和海绵体内皮细胞释放NO的间胆碱对离体兔海绵体的弛豫反应增强。
海绵中的压力增加
在不影响血压和心率的情况下，SNP对麻醉犬的骨盆神经刺激和管内压增加增加（ED50 值：12.0µg/kg 神经刺激，16.2µg/kg SNP；静脉内给药）。
适应症
勃起功能障碍（勃起不足且无法维持满意的性活动的患者）
用法与用量
成人剂量是25毫克至50毫克的西地那非，每天一次，在性活动前约 1 小时口服一次。对于老年患者（65岁或以上）、肝病患者、严重肾病患者（Ccr<30mL/min），已发现本品的血药浓度升高，故应使用25mg。
起始剂量。每日剂量应为一次，给药间隔应至少为24小时。
包装
片剂
25毫克
20片[10片(PTP)x2]
50毫克
20片 [10片(PTP)x2]
100片 [10片(PTP)x10]
口腔崩薄片
25毫克
20张[10张x2]
50毫克
20张[10张x2]、
50张[10张x5]
制造和销售
维特瑞斯药业
Viatris Pharmaceutical Co.Ltd.
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/259000AF1024_4_01/
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Brand name:VIAGRA OD Film 50mg（Sildenafil citrate）
Active ingredient:Sildenafil citrate
Dosage form:light red film, short side: 24 mm, long side: 32 mm, thickness: approx.
0.2 mm
Print on wrapping:(Face) VIAGRA OD Film, 50mg, (Back)服用直前に取り出す, ニトログリセリンなどの硝酸薬と本剤は併用できません, 50mg, バイアグラ OD フィルム 50mg
Effects of this medicine
This medicine helps maintain an erection by increasing cGMP in the corpus cavernosum penis, intensifying relaxationresponse of the cavernous body and improving the inner pressure.It is usually used to improve erectile dysfunction(status of insufficient and unsustainable erection to have satisfactory sexual activity). It does not stimulate orincrease sexual desire.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have: cardiovascular disease, liver dysfunction, hypotension or hypertension, retinitis pigmentosa, sickle cellanemia, multiple myeloma, leukemia, bleeding disorder or peptic ulcer, renal disorder, multiple system atrophy (e.g.Shy-Drager syndrome), structural defect in the penis (e.g. bending penis) or history of cerebral infarction/cerebralhemorrhage or myocardial infarction within recent 6 months.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinaleffects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is(( to be written by a healthcare professional))
・In general, for adults, take 25 to 50 mg of sildenafil at a time, once a day, about 1 hour before sexual activity. Forelderly (at the age of 65 or more) and patients with liver disorder or severe renal disorder, start with 25 mg at atime. This preparation contains 50 mg of sildenafil in a film. Strictly follow the instructions.
・You can take this medicine without water because it dissolves with saliva when you put it on the tongue. Since thismedicine dissolves quickly in the mouth, swallow it with saliva or water. You may take this medicine with water orlukewarm water as an ordinary medicine.
・Take this medicine once a day and wait at least 24 hours to take the next dose. You should never take two doses atone time.
・The effect of this medicine may be affected by taking with food.
・If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
・Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・Sexual activity may put a strain on your heart. Do not overload. This medicine offers no protection against sexuallytransmitted diseases.
・This medicine may cause dizziness or vision disorder (change of color, etc.). Pay close attention when you drive a
car or operate machinery.
・If you experience symptoms such as sudden reduced visual acuity or sudden vision loss, stop taking this medicineand consult with an ophthalmologist immediately.
・Tell your partner that you will take (are taking) this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include vasodilation (hot flush, flush), headache, indigestion andpalpitation. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctorimmediately.
No pertinent entries.
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
・Keep out of reach of children. Store away from direct sunlight, heat and moisture.
Internal
Revised: 02/2021
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a bett。