vkoiuy 2010-3-17 11:34
FDA首次核准Tamsulosin的俗名藥用於BPH
作者：Yael Waknine
出處：WebMD醫學新聞
March 3, 2010 — 美國食品藥物管理局(FDA)首次核准tamsulosin HCl的俗名藥，一種0.4 mg的膠囊(Impax Laboratories公司；商品名Flomax，Astellas Pharma公司，Boehringer Ingelheim Pharmaceuticals公司行銷)。
這個alpha1a–選擇性阻斷劑用於治療良性攝護腺肥大(BPH)，此疾病影響90%的70歲以上男性，包括阻塞性症狀(排尿耗時且困難/小便費力、尿流速變慢/間歇型排尿)以及刺激性症狀(頻尿、夜尿、急尿)。
FDA俗名藥辦公室主任Gary Buehler醫師在該局的新聞稿中表示，核准tamsulosin的俗名藥可以讓良性攝護腺肥大有更廣泛的治療選項，FDA承諾提供俗名藥物給病患使用，且這些藥物符合和原商品名藥物相同嚴格的標準。
Tamsulosin每天服用一次、每次劑量0.4-0.8-mg，餐後約30分鐘時服用。
該藥物的副作用可能包括頭痛、暈眩、鼻炎、感染與異常射精，病患應小心姿勢性低血壓的風險(姿勢性低血壓、暈眩、眼花)，特別是在第一次使用後或者改變劑量時。
其他在部分病患發生過的副作用，包括在白內障手術和陰莖持續勃起症(priapism)手術時發生的術中跳動虹膜症候群(intraoperative floppy iris syndrome)。
FDA Approves First Generic Formulation of Tamsulosin for BPH
By Yael Waknine
Medscape Medical News
March 3, 2010 — The US Food and Drug Administration (FDA) has approved the first generic version of tamsulosin HCl 0.4 mg capsules (Impax Laboratories, Inc; Flomax, Astellas Pharma, Inc, marketed by Boehringer Ingelheim Pharmaceuticals, Inc).
The alpha1a–selective blocker is indicated for the treatment of benign prostatic hyperplasia, a condition that affects up to 90% of men aged 70 years or older. Symptoms are generally obstructive (hesitancy/straining, weak stream/intermittency) and irritative (frequent urination, nocturia, urinary urgency).
"The approval of generic tamsulosin offers greater access to a widely used treatment for [benign prostatic hyperplasia]," said Gary Buehler, director of the FDA's Office of Generic Drugs, in an agency news release. "FDA is committed to making generic drugs available to patients and these drugs meet the same rigid standards as the brand name drugs."
Tamsulosin should be administered once daily as a 0.4- to 0.8-mg dose, approximately 30 minutes after a meal.
Adverse events may include headache, dizziness, rhinitis, infection, and abnormal ejaculation. Patients should be cautioned regarding the risk for orthostasis (postural hypotension, dizziness, and vertigo), particularly after the first dose or when changing doses.
Other adverse events observed in some patients have included intraoperative floppy iris syndrome during cataract surgery and priapism.