英文药名: Rapaflo(Silodosin)

中文药名: 西洛多辛, 赛洛多辛胶囊

生产厂家: Watson Laboratories Inc.

药品简介

FDA 于2008年10月4日批准Watson 公司的silodosin胶囊 (Rapaflo) 用于改善良性前列腺增生（也称为前列腺肥大）（BHP）引起的症状。良性前列腺增生在50岁男性中的发病率为50%，在80年男性中的发病率升高至 75%。本品通过阻断前列腺、膀胱、输尿管中的肾上腺α1受体而起作用，通过阻断这些受体，使得在这些组织中的平滑肌得以放松，从而减轻前列腺增生的症状。

本品为一日1次的胶囊剂，针对无肝肾功能损伤患者的服用剂量为8mg/天，轻中度肝肾功能损伤患者的服用剂量是4mg/天，本品不推荐在重度肝肾功能损伤的患者中使用。两项纳入923例患者为期12周的随机双盲安慰剂对照的多中心临床研究结果表明：本品与安慰剂相比对BHP症状的改善情况与小便通畅率的改善均有显著的统计学意义。

本品的主要不良反应为在性高潮期间没有精液排除或者精液排除减少。但这一不良反应不会纳入对本品的安全性考虑，其他的不良反应还包括眩晕，头昏，腹泻，体位性高血压，头痛，鼻咽炎，鼻充血等。

Description
Rapaflo Capsules is an alpha-blocker used for treating the signs and symptoms of enlarged prostate (benign prostatic hyperplasia [BPH]).

Generic Name for RAPAFLO

Silodosin 4mg, 8mg; caps.

Legal Classification:

Rx

Pharmacological Class for RAPAFLO

α_1A blocker.

Manufacturer of RAPAFLO

Watson Pharmaceuticals, Inc.

Indications for RAPAFLO

Benign prostatic hyperplasia.

Adult dose for RAPAFLO

Take with food once daily. Normal renal function: 8mg. Renal impairment (CrCl 30–50mL/min): 4mg.

Children's dosing for RAPAFLO

Not recommended.

Contraindications for RAPAFLO

Severe renal impairment (CrCl <30mL/min). Severe hepatic impairment (Child-Pugh score ≥10). Concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, ritonavir).

Warnings/Precautions for RAPAFLO

Not for treating hypertension. Exclude prostate cancer. Anticipated cataract surgery (may cause intraoperative floppy iris syndrome; advise ophthalmologist). Pregnancy (Cat.B), nursing mothers: not applicable (not indicated for use in women).

Interactions for RAPAFLO

See Contraindications. Concomitant other α-blockers, other strong P-glycoprotein inhibitors (eg, cyclosporine): not recommended. May be potentiated by moderate CYP3A4 inhibitors (eg, erythromycin, diltiazem, verapamil). Caution with other antihypertensives.

Adverse Reactions for RAPAFLO

Retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, nasal congestion.

How is RAPAFLO supplied?

Caps 4mg—30, 100; 8mg—30, 90

包装规格：
·4mg 30 粒（胶囊）
·8mg 30 粒（胶囊