Bismuth subcitrate potassium

Overview

A bismuth compound used for peptic ulcer and gastro-oesophageal reflux disease (GORD).

Indication

For the treatment of peptic ulcer and gastro-oesophageal reflux disease (GORD). Treatment of inflammatory and erosive-ulcerous diseases of gastric and duodenal mucosa: gastritis, ulcer disease of the stomach and duodenum, functional non-ulcerous dyspepsia, erosive duodenitis, post-operative inflammatory and erosive changes – anastomositis, peptic ulcer of anastomosis

Associated Conditions

Cough, Acute
Helicobacter Pylori Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication	2019/04/24	NCT03925818	Not Applicable	Terminated	Università degli Studi di Sassari

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride	Ingenus Pharmaceuticals, LLC	50742-283	ORAL	140 mg in 1 1	7/4/2023
PYLERA	H2-Pharma, LLC	61269-380	ORAL	140 mg in 1 1	10/19/2023
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride	Par Pharmaceutical, Inc.	49884-151	ORAL	140 mg in 1 1	3/15/2023
Pylera	Physicians Total Care, Inc.	54868-6151	ORAL	140 mg in 1 1	3/14/2011
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE	H2-Pharma, LLC	61269-385	ORAL	140 mg in 1 1	5/31/2023
Pylera	Allergan, Inc.	58914-601	ORAL	140 mg in 1 1	11/15/2023

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

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

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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