【24drs.com】March 3, 2010 — 美国食品药物管理局(FDA)首次核准tamsulosin HCl的俗名药,一种0.4 mg的胶囊(Impax Laboratories公司;商品名Flomax,Astellas Pharma公司,Boehringer Ingelheim Pharmaceuticals公司营销)。
  FDA俗名药办公室主任Gary Buehler医师在该局的新闻稿中表示,核准tamsulosin的俗名药可以让良性摄护腺肥大有更广泛的治疗选项,FDA承诺提供俗名药物给病患使用,且这些药物符合和原商品名药物相同严格的标准。
  其它在部分病患发生过的副作用,包括在白内障手术和阴茎持续勃起症(priapism)手术时发生的术中跳动虹膜症候群(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.

2010/5/5 下午 04:44:00
2007/6/4 下午 05:51:00
2006/6/2 上午 11:55:00

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