Products

Pylera®

Product Information

PYLERA® (bismuth subcitrate potassium, metronidazole, tetracycline HCl) is an effective 3-in-1 capsule for the first line option in the eradication treatment of H. pylori, a bacteria that is now believed to cause up to90% of duodenal ulcers, Partnered with Aptalis Pharma. 

Description

PYLERA® capsules are a combination antimicrobial product containingbismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration.

Active Substance

Bismuth subcitrate potassium 140 mg, metronidazole 125 mg, tetracycline hydrochloride 125 mg given as 3 capsules q.i.d. plus omeprazole for 10 days.

Indication

PYLERA® capsules, in combination with omeprazole (20 mg b.i.d), areindicated for the treatment of patients with Helicobacter pylori infection andduodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

Regulatory Status

Approved by US FDA in September 2006, Code # 200872, Revision Date: May 24, 2007

Currently under registration in the AfMET region.

PYLERA® is a trademark owned by Axcan Pharma Inc. used under license by NewBridge Pharmaceuticals Ltd. BVI.