Bethanechol

Overview

Bethanechol is a synthetic ester that was initially synthesized in 1935. As a cholinergic agent, bethanechol is similar in structure and pharmacological function to acetylcholine and is used in specific cases when stimulation of the parasympathetic nervous system is necessary. For example, bethanechol is readily used to treat postoperative or postpartum urinary retention. An advantage of bethanechol is that in contrast to acetylcholine, bethanechol is not degraded by cholinesterase allowing its effects to be longer-lasting.

Indication

Bethanechol is indicated for the treatment of acute, functional postpartum and postoperative urinary retention. It is also indicated for the treatment of neurogenic atony of the bladder with retention.

Associated Conditions

Acute post-operative Urinary retention
Neurogenic atony of the urinary bladder
Non-obstructive postpartum urinary retention

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate Pharmacokinetic and Pharmacodynamic Drug Interactions and Safety of IY-HCR21 and IY-MIC	2024/06/24	NCT06471868	Phase 1	Active, not recruiting	Il-Yang Pharm. Co., Ltd.
The Effect of Bethanechol on Tracheobronchomalacia	2022/03/28	NCT05299008	N/A	Recruiting	Arkansas Children's Hospital Research Institute
Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma	2022/02/15	NCT05241249	Phase 2	Recruiting	Susan E. Bates
Bethanechol Prior to Pancreatic Surgery	2018/06/28	NCT03572283	Early Phase 1	Completed	Columbia University
Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB - IIA	2016/09/22	NCT02910596	Phase 4	Completed	Rajavithi Hospital
Bethanechol for Eosinophilic Esophagitis	2014/02/10	NCT02058537	Phase 2	Terminated	University of Iowa
The Effects of Bethanechol on Glucose Homeostasis	2011/09/15	NCT01434901	Phase 1	Completed	Washington University School of Medicine
Proof-of-concept (PoC) Study of APD515	2011/04/08	NCT01331746	Phase 2	Completed	Acacia Pharma Ltd
Topical Bethanechol for Improvement of Esophageal Dysmotility	2009/12/14	NCT01031043	Phase 1	Completed	Augusta University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Bethanechol Chloride	Bryant Ranch Prepack	63629-2023	ORAL	10 mg in 1 1	2/28/2020
Bethanechol Chloride	Lannett Company, Inc.	0527-1340	ORAL	10 mg in 1 1	3/24/2020
Bethanechol Chloride	Amneal Pharmaceuticals LLC	65162-572	ORAL	10 mg in 1 1	12/18/2023
Bethanechol Chloride	Physicians Total Care, Inc.	54868-5154	ORAL	50 mg in 1 1	9/19/2012
Bethanechol Chloride	Upsher-Smith Laboratories, LLC	0832-0510	ORAL	5 mg in 1 1	2/8/2023
Bethanechol Chloride	Lannett Company, Inc.	0527-1356	ORAL	25 mg in 1 1	3/24/2020
Bethanechol Chloride	Physicians Total Care, Inc.	54868-1624	ORAL	10 mg in 1 1	9/19/2012
Bethanechol Chloride	Chartwell RX, LLC	62135-757	ORAL	25 mg in 1 1	1/22/2024
Bethanechol Chloride	Bryant Ranch Prepack	63629-2022	ORAL	5 mg in 1 1	2/28/2020
Bethanechol Chloride	Marlex Pharmaceuticals Inc	10135-517	ORAL	25 mg in 1 1	6/3/2015

EMA Drug Approvals

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

HSA Drug Approvals

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

NMPA Drug Approvals

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

PPB Drug Approvals

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

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
UROCARB bethanechol chloride 10 mg tablet	14861	Mayne Pharma International Pty Ltd	Medicine	A	9/5/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PHL-BETHANECHOL CHLORIDE	pharmel inc	02237049	Tablet - Oral	50 MG	2/17/1998
URECHOLINE TAB 10MG	merck frosst canada & cie, merck frosst canada & co.	00349720	Tablet - Oral	10 MG / TAB	12/31/1976
PMS-BETHANECHOL CHLORIDE TAB 10MG	Pharmascience Inc	00759171	Tablet - Oral	10 MG	12/31/1990
MYOTONACHOL TABLETS 10MG	glenwood laboratories canada ltd.	01985671	Tablet - Oral	10 MG	12/31/1993
URECHOLINE TAB 25MG	merck frosst canada & cie, merck frosst canada & co.	00349739	Tablet - Oral	25 MG / TAB	12/31/1976
MYOTONACHOL TABLETS 25MG	glenwood laboratories canada ltd.	01985558	Tablet - Oral	25 MG	12/31/1993
PHL-BETHANECHOL CHLORIDE	pharmel inc	02237047	Tablet - Oral	10 MG	2/17/1998
PMS-BETHANECHOL CHLORIDE TAB 25MG	Pharmascience Inc	00739162	Tablet - Oral	25 MG	12/31/1990
DUVOID	Endo Operations Ltd.	01947958	Tablet - Oral	10 MG	12/31/1992
PMS-BETHANECHOL CHLORIDE TAB 50MG	Pharmascience Inc	00759198	Tablet - Oral	50 MG	12/31/1990

CIMA AEMPS Drug Approvals

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

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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