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.
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