Bismuth, Metronidazole, Tetracycline

Products

The fixed combination Pylera with the active ingredients bismuth, metronidazole, and tetracycline was approved in many countries in 2017 in the form of hard capsules. In some countries, it was available much earlier, for example, in the United States since 2006. This treatment is the so-called bismuth quadruple therapy (“BMTO”), which was developed by Tom Borody in Australia back in the 1980s. Several variations exist.

Ingredients

The capsules contain the following ingredients:

  • Bismuth subcitrate potassium
  • Tetracycline hydrochloride
  • Metronidazole

Omeprazole must be administered additionally and is not included in the drug.

Effects

The three active ingredients have antibacterial properties against . Several mechanisms have been described for bismuth. Among other things, it damages the bacterial membrane and inhibits protein and cell wall formation. However, bismuth not only acts against bacteria, but also exerts additional effects on the organism. For example, it has anti-inflammatory properties, inhibits pepsin and binds bile acids. Tetracycline binds to the 30S subunit of bacterial ribosomes and thus interferes with protein synthesis. Metronidazole is a prodrug that is metabolized under anaerobic conditions in the cell to nitroso radicals that attack DNA. This results in strand breaks, inhibition of DNA synthesis, and cell death. The PPI omeprazole, which is additionally administered, reduces the secretion of gastric acid by irreversibly inhibiting the proton pump in the occupant cells of the stomach. Omeprazole counteracts resistance to metronidazole.

Indications

  • In combination with omeprazole for eradication of .
  • For prevention of recurrent peptic ulcer in patients with ulcers induced by H. pylori (active or history).

Dosage

According to the professional information. During 10 days, 3 capsules are taken four times a day. 3 capsules after breakfast, 3 capsules after lunch, 3 capsules after dinner, and 3 capsules before bedtime, preferably after a snack. Omeprazole is taken in a dose of 20 mg after breakfast and after dinner. The capsules are swallowed with a full glass of water. Because of metronidazole, alcohol should not be consumed during and up to three days after treatment. Because of the tetracycline, good sun protection is recommended during therapy. This is because tetracyclines can make the skin more sensitive to sunlight.

Contraindications

  • Hypersensitivity, including to other nitroimidazoles.
  • Pregnancy and lactation
  • Children and adolescents (up to 12 years)
  • Kidney or liver dysfunction

The complete and numerous precautions can be found in the drug label.

Interactions

There is a high potential for drug interactions. Refer to the SmPC for complete details.

Adverse effects

The most common potential adverse effects include: