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
Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms	2016/03/22	NCT02715024	Phase 4	Completed	Astellas Pharma Taiwan, Inc.
Pharmacokinetics and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 in Healthy Male Volunteers	2016/03/18	NCT02712411	Phase 1	Completed	Hanmi Pharmaceutical Company Limited
Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention	2016/02/18	NCT02684344	Not Applicable	Terminated	University of Rochester
A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)	2016/01/14	NCT02656173	Phase 4	Completed	Astellas Pharma Inc
EC905 Pharmacokinetic Profile Study	2015/12/18	NCT02634489	Phase 1	Completed	Astellas Pharma Europe B.V.
Actual Use Study of Tamsulosin in Men	2015/10/09	NCT02573311	Phase 3	Completed	Boehringer Ingelheim
Investigating the Pharmacokinetic Characteristics of HIP1402 in Healthy Male Volunteers	2015/08/20	NCT02529800	Phase 1	Completed	Hanmi Pharmaceutical Company Limited
Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients	2015/08/10	NCT02518971	Phase 3	Terminated	University of Michigan
Prevention of Post-operative Urinary Retention	2015/07/01	NCT02486653	Phase 3	Completed	University of Wisconsin, Madison
Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Pain in the Pediatric Population	2015/06/29	NCT02483793	Not Applicable	UNKNOWN	Phoenix Children's Hospital

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tamsulosin Hydrochloride	NuCare Pharmaceuticals, Inc.	68071-1934	ORAL	0.4 mg in 1 1	11/10/2022
TAMSULOSIN HYDROCHLORIDE	Proficient Rx LP	71205-748	ORAL	0.4 mg in 1 1	1/1/2023
TAMSULOSIN HYDROCHLORIDE	H.J. Harkins Company, Inc.	52959-034	ORAL	0.4 mg in 1 1	1/19/2012
TAMSULOSIN HYDROCHLORIDE	DIRECT RX	61919-703	ORAL	0.4 mg in 1 1	11/9/2018
Tamsulosin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	43353-663	ORAL	0.4 mg in 1 1	4/30/2014
Tamsulosin Hydrochloride	Bryant Ranch Prepack	71335-0398	ORAL	0.4 mg in 1 1	9/9/2021
FLOMAX	RedPharm Drug, Inc.	67296-1803	ORAL	0.4 mg in 1 1	1/21/2022
Tamsulosin Hydrochloride	A-S Medication Solutions	50090-1846	ORAL	0.4 mg in 1 1	11/17/2023
Tamsulosin Hydrochloride	NuCare Pharmaceuticals,Inc.	68071-2197	ORAL	0.4 mg in 1 1	7/7/2021
Flomax	Physicians Total Care, Inc.	54868-4356	ORAL	0.4 mg in 1 1	9/2/2010

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

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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