英文药名：Vitaros（alprostadil） 中文药名：前列腺素E1乳膏（前列地尔霜） 生产厂家：Apricus生物 给药说明 前列地尔经皮释药制剂Vitaros为一线治疗男子勃起功能障碍获加拿大批准 2010年11月,加拿大卫生部批准了Apricus生物科学有限公司开发的前列地尔(alprostadil)局部用制剂Vitaros,用于一线治疗男子勃起功能障碍。前列地尔属血管扩张剂,先前已获准可以阴茎海绵体内注射剂或尿道内插入用栓剂治疗勃起功能障碍。 Vitaros系应用Apricus生物科学有限公司自己的名为NexACT的专有释药技术制备,是局部用经皮释药制剂,可按需用药并具有在用药后数分钟内即起效且安全性好、能用于正在服用α-阻滞剂或硝酸酯类药物患者(此为口服勃起功能障碍治疗药物的绝对禁忌)等特点,为勃起功能障碍男子提供了一种“患者友好”的新型治疗选择。 适应症 本品适用于勃起功能障碍患者的治疗。 用法和用量 在性交前5～20分钟使用，每次使用本品一支（含前列腺素E1 1mg）。 1．用药前先排尿，用肥皂水清洗双手及生殖器。 2．撕开吸泡铝塑包装，取出给药管。取下给药管小盖。 3．用左手食、拇指轻压龟头，使尿道口张开。 4．将给药管嘴轻轻地对准尿道口，右手食指推压给药管推杆（以右手拇指及中指夹住给药管）将管中的乳膏剂尽量挤入尿道中。 5．由尿道溢出的乳膏，涂于龟头表面至均匀。 不良反应 偶有局部轻微红肿，龟头、尿道疼痛，停药后自然消失。 禁忌 1．对前列腺素E1过敏。 2．阴茎异常、尿道狭窄、或患龟头炎及各种急、慢性尿道炎。 3．患镰刀细胞贫血、血小板增多症、红细胞增多症、多发性骨髓瘤。 4．有静脉血栓倾向或高粘度血症者。 5．当配偶为孕妇或计划妊娠时。 6．不适合进行性生活的男性。 注意事项 1．使用本药品前应进行体检以排除禁忌症的可能。 2．需注意低血压症状的发生。 3．有阴茎异常勃起现象者，应减少或停止本药品的使用。 贮藏 密封，2～8℃保存。 产地：德国Hexal Vitaros cream (alprostadil) Erectile dysfunction Alprostadil Takeda How does it work? Vitaros cream contains the active ingredient alprostadil, which is a type of medicine called a prostaglandin. Alprostadil is the same as a naturally occurring chemical called prostaglandin E1. This prostaglandin is thought to cause some types of blood vessels to widen by relaxing the thin layer of muscle found in the vessel wall. An erection is produced via a complex chain of events, involving signals from the nervous system and the release of active chemicals, including prostaglandin E1 within the tissues of the penis. These chemicals cause blood vessels entering the penis to widen, allowing more blood to enter, and other blood vessels leaving the penis to constrict, stopping blood from leaving the penis. Prostaglandin E1 plays an important role in this process and alprostadil, when administered directly into opening at the end of the penis (urethra), will ultimately cause the penis to become rigid and erect by increasing the blood flow into its tissues. Vitaros cream is applied to the tip of the penis from a single dose container called the AccuDose container. It should produce an erection within 5 to 30 minutes. What is it used for? •Treating erectile dysfunction (impotence). How do I use it? •It is important to carefully follow your doctor's instructions and the instructions provided with the medicine. •Vitaros cream is applied to the tip of the penis using the AccuDose container. To do this you widen the opening of the penis with one hand and with the other hand hold the AccuDose container with the tip just over the opening of the penis. Push down the plunger until all the cream is pushed out of the container. DO NOT INSERT THE TIP OF THE ACCUDOSE CONTAINER INTO THE OPENING OF THE PENIS. •Hold the penis upright for 30 seconds to allow the cream to penetrate. It is likely that excess cream will remain on the tip of the penis. You should rub this gently into the skin around the opening of the penis with a fingertip. •Wash your hands after applying the cream, as it can irritate the eyes if you accidentally get it in them. •Each AccuDose container contains one dose of Vitaros cream. It is only used once and then discarded. Replace the cap on the container after use and put it back in the sachet to dispose of it. •After administration it will take about 5 to 30 minutes for an erection to develop. The effects of the medicine can last for one to two hours. •Do not use more than one dose in any 24 hour period. •Do not use more than two or three doses in any seven days. •The unopened sachets containing the AccuDose containers should be stored in a fridge at 2-8ºC. Do not freeze them. However, they may be kept out of the fridge below 25ºC for up to three days before use. (If they are not used in this time they should be disposed of.) Warning! •This medicine may make you feel dizzy for up to two hours after using it. As a result it could reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance. •When using Vitaros cream it is recommended that you use a condom during sex, including oral and anal sex, because Vitaros cream may have side effects on your partner, for example vaginal irritation. •This medicine will not protect you or your partner from sexually transmitted diseases. Using a condom can provide this protection. •If your erection lasts longer than four hours (priapism), consult a doctor immediately. Treatment of this condition should not be delayed more than six hours, as this can cause damage to the erectile tissue in the penis and irreversible erectile dysfunction. Use with caution in •Men with decreased liver function. •Men with decreased kidney function.