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当前位置:药品说明书与价格首页 >> 男性科 >> 新药推存 >> 度他雄胺片(胶囊)Avodart(Dutasteride Tablets)

度他雄胺片(胶囊)Avodart(Dutasteride Tablets)

2011-02-14 11:33:17  作者:新特药房  来源:中国新特药网天津分站  浏览次数:1701  文字大小:【】【】【
简介: 英文药名: Avodart (Dutasteride Tablets) 中文药名: 度他雄胺片(胶囊) 生产厂家: Glaxo Smith Kline 药品名称 英文药名: Avodart (Dutasteride Tablets) 中文药名: 度他雄胺 药品说明 AVODAR ...

英文药名: Avodart (Dutasteride Tablets)

中文药名: 度他雄胺片(胶囊)

生产厂家: Glaxo Smith Kline


 药品名称

英文药名: Avodart (Dutasteride Tablets)
中文药名: 度他雄胺
药品说明

AVODART 的成份为Dutasteride(度他雄胺),是一种的双重5α-还原酶阻挡剂, 可阻断两种催化睾酮转化产生DHT的5α-还原酶。Dutasteride是2002年10月9日被美国食品药物管理局核准用于治疗前列腺肿大的新药,而针对脱发治疗的临床试验结果还处于等待FDA的核准中。5α-还原酶又分两种类型:第Ⅰ型和第Ⅱ型,5α-Ⅰ型还原酶主要是存在于毛囊基部的外鞘细胞以及基质细胞和毛囊旁边的皮脂腺内;5α-Ⅱ型还原酶主要存在于毛囊基部的内鞘细胞里面。如果只是抑制5α-Ⅱ型还原酶,只能挽救毛囊基部内鞘细胞免于死亡,而Dutasteride (药品名Avodart)则可以同时抑制伤害毛囊细胞组织的5α-Ⅰ型还原酶和5α-Ⅱ型还原酶,同时挽救外鞘细胞以及基质细胞,从而使毛囊得到更加周全的保护,脱发部位也可得到更高程度的恢复,根据国外初步的临床试验,用药六个月后,AVODART新生头发的效果比保法止多三分之一。
美国FDA批准度他雄胺与坦索罗辛联用治疗前列腺增生症:2008年6月19日,葛兰素史克公司宣布美国FDA批准其度他雄胺(dutasteride, Avodart)与坦索罗辛(tamsulosin, Harnal)联用治疗前列腺增生症。
度他雄胺是首个也是唯一用于治疗前列腺增生的双重5α还原酶抑制剂,能够改善泌尿系统症状、降低急性尿潴留发作与进行有关前列腺手术的风险。坦索罗辛为α受体阻断剂,能改善前列腺增生的症状。
美国FDA的此次批准基于1项为期2年的多中心随机双盲对照的临床研究――首个长期评价度他雄胺与α受体阻断剂联用的临床研究。纳入的患者为中度至重度前列腺增生男性患者(年龄大于或等于50岁,前列腺体积(PV)≥30cc,血清前列腺特异性抗原(PSA)水平为1.5~10ng/mL,5mL/秒<最大尿流率(Qmax)≤15mL/秒,最小排尿量≥125mL,国际前列腺症状评分(IPSS)≥12)。患者先服用安慰剂4个星期,再随机服用度他雄胺0.5mg/天与坦索罗辛0.4mg/天,单用度他雄胺0.5mg/天或坦索罗辛0.4mg/天。
此项临床研究表明:12~24个月后,联用度他雄胺与坦索罗辛,其治疗效果优于单方治疗。本品最常见的不良反应有阳痿、性欲减退、乳腺疾病(包括乳房增大、肿胀)、射精障碍和眩晕。
适应症

前列腺肿大、男性型脱发、脂溢性脱发、遗传性脱发 (女性及儿童切忌服用)
注意事项

服药期间及停药后6个月之内,请勿捐血,或让女性怀孕。
任何疑问,请遵医嘱!

Dutasteride capsules

 

What are dutasteride capsules?

DUTASTERIDE (Avodart™) can reduce the size of the prostate gland in men with benign prostatic hyperplasia (BPH). The prostate is a part of the male reproductive system that produces a milky fluid for sperm. Over the age of 50 most men develop an enlarged prostate. As the prostate gets bigger it can restrict the flow of urine. Dutasteride can help to reduce symptoms caused by BPH such as a weak or interrupted urine flow; a feeling that the bladder is not completely empty; a need to pass urine more often, especially at night; an urgent feeling that you must pass urine right away; a delay or hesitation when you start to urinate. Dutasteride also reduces the risk of the need for BPH-related surgery. While some men have fewer problems and symptoms after 3 months of treatment, at least 6 months is usually necessary to see if dutasteride will work for you. Dutasteride is not for use in women. Generic dutasteride capsules are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• if you are female (dutasteride is not for use in women)
• liver disease
• prostate cancer
• an unusual or allergic reaction to dutasteride, finasteride (Proscar®, Propecia®), other medicines, foods, dyes, or preservatives

How should I take this medicine?

Take dutasteride capsules by mouth. Follow the directions on the prescription label. Swallow the capsules whole with a drink of water. Do not chew or open the capsules because the contents may irritate your lips, mouth, or throat. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, you can take it later that day. If you do not remember until the next day, take only that day's dose. Do not take double or extra doses. Try taking the dose at the same time every day to help you remember to take your dose.

What drug(s) may interact with dutasteride?

amiodarone
cimetidine
• clarithromycin, erythromycin, or troleandomycin
• diltiazem, nicardipine, or verapamil
• isoniazid
• male hormones (example: testosterone)
quinine
• saw palmetto
• some antidepressants (examples: fluvoxamine, fluoxetine, nefazodone)
• some antifungal medicines (examples: ketoconazole, itraconazole, voriconazole)
• some medicines for HIV infection (examples: delavirdine, efavirenz, indinavir, ritonavir, saquinavir)
• soy isoflavones supplements
zafirlukast

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking dutasteride?

Do not donate blood until at least 6 months after your final dose of dutasteride. This will prevent giving dutasteride to a pregnant female through a blood transfusion.

Contact your prescriber or health care professional if there is no improvement in your symptoms. You may need to take dutasteride for 6 to 12 months to get the best results.

Dutasteride is not for use in females. Females who are pregnant or may get pregnant must not handle dutasteride capsules. If a woman who is pregnant gets enough dutasteride into her body after swallowing it or through her skin after handling it, the medication could harm the unborn baby, particularly if the baby is male. If a pregnant woman comes into contact with dutasteride capsules she should check with her health care professional.

Dutasteride may interfere with PSA laboratory tests for prostate cancer. If you are scheduled to have a lab test for prostate cancer, tell your prescriber or health care professional that you are taking dutasteride.

What side effects may I notice from taking dutasteride?

Side effects that you should report to your doctor or health care professional as soon as possible:
• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in breast like lumps, pain or fluids leaking from the nipple
• pain in the testicles

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
• change in sex drive or performance

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Avodart™ is a soft gelatin capsule that may become soft and leak or may stick to other capsules if kept at high temperatures. Store capsules at room temperature at or below 25 degrees C (77 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

If your capsules are cracked or leaking, do not use them, and contact your pharmacist.

责任编辑:admin


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