Company:

Axcan Pharma

Antimicrobial/antibiotics

Bismuth subcitrate potassium 140mg, metronidazole 125mg, tetracycline HCl 125mg; caps.

To eradicate H. pylori, in combination with omeprazole, in patients with H. pylori infection and duodenal ulcer disease (active or history of).

Pylera combines the antimicrobial agent, bismuth subcitrate potassium, with two antibiotics, metronidazole and tetracycline. Bismuth subcitrate potassium has similar effects as bismuth subsalicylate; however, it does not carry the risks associated with the salicylate moiety found in other products. Tetracycline interacts with the 30S subunit of the bacterial ribosome and inhibits protein synthesis. Metronidazole is metabolized through reductive pathways into reactive intermediates that have cytotoxic action.

Pylera should be taken in combination with omeprazole, and it should be used only to treat or prevent infections that are proven to be or are strongly suspected of being caused by susceptible bacteria.

An open-label, parallel group, active-controlled, multicenter study involving 275 H. pylori positive patients with current duodenal ulcer or history of duodenal ulcer disease was conducted in the U.S. and Canada. Patients were randomized to receive either Pylera + omeprazole or clarithromycin + amoxicillin + omeprazole. H. pylori eradication was defined as two negative ₁₃C-urea breath tests performed at 4 and 8 weeks post-therapy. On an intent-to-treat basis, the eradication rates, although not statistically significant, were 87.7% for the Pylera + omeprazole group versus 83.2% for the clarithromycin + amoxicillin + omeprazole group.

Take with 8 oz water. 3 caps 4 times daily after meals and at bedtime for 10 days (give with omeprazole 20mg twice daily with breakfast and dinner for 10 days).

See Contraindications.

Renal or hepatic impairment. Pediatric patients. Pregnancy (Cat.D). Nursing mothers.

Blood dyscrasias. CNS disease. Discontinue if abnormal neurological signs or skin erythema occurs. Avoid sun, UV light.

Avoid alcohol during and for at least 1 day after therapy. Recent (within 2 weeks) therapy with disulfiram: not recommended. May antagonize oral contraceptives (use non-hormonal backup method). May interfere with bactericidal anti-infectives (eg, penicillin). Tetracycline absorption reduced by antacids containing aluminum, magnesium, or calcium; and by iron, zinc, sodium bicarbonate, and dietary calcium (clinical significance unknown). Fatal renal toxicity with methoxyflurane. Metronidazole levels increased by cimetidine, others that inhibit hepatic microsomal enzymes. Metronidazole levels decreased by phenytoin, phenobarbital, other drugs that induce hepatic microsomal enzymes. Monitor phenytoin, lithium, anticoagulants. May interfere with GI X-rays, liver function tests, others.

GI effects (diarrhea, dyspepsia, abdominal pain, nausea, gastritis, flatulence), darkening of tongue and/or stool, headache, flu syndrome, taste perversion, asthenia, superinfection (eg, vaginitis), dizziness, rash.

Caps—120

For more information call (800) 950-8085.

6/27/07