PYLERA® Capsules plus BID omeprazole 20mg achieve a high level of eradication2

O’Morain et al. 2003
Eradication Rates for PYLERA® 10-Day Regimen2,*,‡


Adapted from O’Morain et al., Aliment Pharmacol Ther, 2003.

‡ Data based on an international, multicenter study that assessed the efficacy of quadruple therapy using single-triple capsules of bismuth biskalcitrate (140 mg), metronidazole (125 mg) and tetracycline (125 mg) given with omeprazole (20 mg). 170 patients were treated in 8 centers located in 5 countries including the US. Patients received 3 single-triple capsules q.i.d. and omeprazole b.d. Overall eradication rates were 93% (158/170) by modified intent-to-treat analysis and 97% (142/146) by per protocol analysis.

*PYLERA® Regimen = bismuth subcitrate potassium 140 mg, metronidazole 125 mg, tetracycline 125 mg given as 3 capsules q.i.d. plus omeprazole 20 mg b.i.d.

Tetracycline hydrochloride should not be used during pregnancy (see WARNINGS above about use during tooth development). Results of animal studies indicate that tetracycline crosses the placenta, is found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Reference
2. O’Morain C, et al . Efficacy and safety of single-triple capsules of bismuth biskalcitrate, metronidazole and tetracycline, given with omeprazole, for the eradication of Helicobacter pylori: an international multicentre study. Aliment Pharmacol Ther 2003; 17: 415-420.