Propantheline

Overview

A muscarinic antagonist used as an antispasmodic, in rhinitis, in urinary incontinence, and in the treatment of ulcers. At high doses it has nicotinic effects resulting in neuromuscular blocking.

Indication

For the treatment of enuresis. It has also been used for hyperhidrosis, and cramps or spasms of the stomach, intestines or bladder.

Associated Conditions

Peptic Ulcer
Gastrointestinal spasms

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder	2012/07/13	NCT01640002	Phase 1	UNKNOWN	Hospital Universitário Professor Edgard Santos
Bioavailability of Vagantin® Coated Tablets Relative to an Oral Methantheline Bromide Solution	2011/09/05	NCT01429090	Phase 1	Completed	University Medicine Greifswald

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
PRO-BANTHINE Propantheline bromide 15mg tablets	207283	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/17/2013

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PRO-BANTHINE TABLETS 7.5 MG	Wellspring Pharmaceutical Canada Corp	02030829	Tablet - Oral	7.5 MG	12/31/1994
PRO-BANTHINE TABLETS 15MG	Wellspring Pharmaceutical Canada Corp	02030837	Tablet - Oral	15 MG	12/31/1994

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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