Tamsulosin

Overview

Tamsulosin is a selective alpha-1A and alpha-1B adrenoceptor antagonist that exerts its greatest effect in the prostate and bladder, where these receptors are most common. It is indicated for the treatment of signs and symptoms of benign prostatic hypertrophy. Antagonism of these receptors leads to relaxation of smooth muscle in the prostate and detrusor muscles in the bladder, allowing for better urinary flow. Other alpha-1 adrenoceptor antagonists developed in the 1980s were less selective and more likely to act on the smooth muscle of blood vessels, resulting in hypotension. Tamsulosin was first approved by the FDA on April 15, 1997.

Indication

Tamsulosin is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Tamsulosin is also used off label for the treatment of ureteral stones, prostatitis, and female voiding dysfunction.

Associated Conditions

Benign Prostatic Hyperplasia (BPH)
Benign Prostatic Hypertrophy
Bladder Outlet Obstruction
Ureteral Calculus

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi	2023/08/04	NCT05977647	Phase 4	Completed	Getz Pharma
Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome	2023/06/06	NCT05890235	Phase 4	Completed	Xintian Pharmaceutical
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH	2023/04/28	NCT05834270	Not Applicable	Completed	Menoufia University
Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study	2023/04/19	NCT05818670	Phase 4	Completed	Mansoura University
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI	2023/03/30	NCT05790902	Phase 1	Completed	Armed Forces Institute of Urology, Rawalpindi
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis	2023/03/08	NCT05759767	Not Applicable	Active, not recruiting	Mansoura University
Effect of Preoperative Tamsulosin on Postoperative Urinary Retention	2023/03/03	NCT05753670	Phase 3	Completed	NorthShore University HealthSystem
Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery	2022/12/20	NCT05657990	Early Phase 1	Recruiting	Hackensack Meridian Health
Silodosin vs Tamsulosin as MET	2022/10/06	NCT05570084	Phase 3	Recruiting	Princess Margaret Hospital, Hong Kong
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia	2022/09/22	NCT05551221	Phase 4	Recruiting	Xintian Pharmaceutical

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tamsulosin Hydrochloride	Ascend Laboratories, LLC	67877-450	ORAL	0.4 mg in 1 1	11/16/2021
TAMSULOSIN HYDROCHLORIDE	STAT RX USA LLC	16590-298	ORAL	0.4 mg in 1 1	7/11/2011
Tamsulosin Hydrochloride	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	60723-056	ORAL	0.4 mg in 1 1	5/26/2020
Tamsulosin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	43063-947	ORAL	0.4 mg in 1 1	10/18/2023
JALYN	Physicians Total Care, Inc.	54868-6328	ORAL	0.4 mg in 1 1	5/16/2012
Tamsulosin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	70934-092	ORAL	0.4 mg in 1 1	1/1/2023
Tamsulosin Hydrochloride	RedPharm Drug, Inc.	67296-1739	ORAL	0.4 mg in 1 1	1/21/2022
Tamsulosin hydrochloride	EXELAN PHARMACEUTICALS, INC.	76282-744	ORAL	0.4 mg in 1 1	2/1/2025
Tamsulosin Hydrochloride	Cardinal Health 107, LLC	55154-2142	ORAL	0.4 mg in 1 1	8/28/2025
Tamsulosin Hydrochloride	NuCare Pharmaceuticals,Inc.	68071-4872	ORAL	0.4 mg in 1 1	2/17/2021

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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