Pylera 140 mg + 125 mg + 125 mg, 120 capsules: profile, composition and research

Reference page for Pylera 140 mg + 125 mg + 125 mg, 120 capsules. Active substance: Висмута цитрат калия + метронидазол + тетрациклина гидрохлорид / Bismuth subcitrate potassium + metronidazole + tetracycline hydrochloride.

Key facts

What Pylera is

Pylera is a prescription medicine for Helicobacter pylori infection in adults. A single capsule combines three active substances: bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride, making it a ready-made combination form. The form is intended for use on a physician's instruction.

Metronidazole and tetracycline belong to the antibacterial group, while the bismuth salt supports their action. The combination is used as part of so-called quadruple therapy, in which the fourth element is an agent that lowers stomach acidity. Together they cover different aspects of the bacterium.

The product comes as hard capsules, with 120 capsules in a pack. Each capsule contains 140 mg of bismuth subcitrate potassium, equivalent to 40 mg of bismuth oxide, plus 125 mg each of metronidazole and tetracycline hydrochloride. These amounts are stated by the manufacturer.

How the combination acts

Tetracycline blocks protein synthesis in the bacterial cell, while metronidazole damages its DNA in the absence of oxygen. These mechanisms complement each other and make survival harder for the bacterium within the stomach lining. The two agents therefore attack the bacterium in different ways.

The bismuth salt forms a protective layer on the mucosal surface and helps the antibacterial components work better. Bismuth itself also has a suppressive effect on Helicobacter pylori, which adds to the overall result of the regimen. That layer also shields the lining from irritants.

The fourth component of the regimen is usually a proton pump inhibitor such as omeprazole: it lowers stomach acidity and creates conditions in which the antibacterial agents act more effectively. Without it the efficacy of the regimen falls. The regimen is therefore used only together with it.

Approved uses

The prescribing information covers use in adults to clear Helicobacter pylori, including in gastric and duodenal ulcer disease associated with the bacterium and in other forms of the infection. The medicine is given after the infection is confirmed. Treatment follows confirmation of the bacterium.

The medicine is used together with a proton pump inhibitor. The regimen, its length and the need for a repeat course are decided by a gastroenterologist after assessment and with earlier treatment in mind. A repeat course is given on specific grounds only.

Treatment calls for strict adherence to the prescribed schedule, because missed doses of antibacterial agents lower the chance of clearing the bacterium. Effectiveness is checked after the course is finished. Testing is done no earlier than the time a physician sets, so that the result is reliable.

What the research shows

Bismuth-containing quadruple regimens have been examined in numerous clinical studies. A 2024 randomised trial compared 10-day and 14-day courses of such therapy and assessed how often the bacterium was cleared. Tolerability and side-effect rates were also compared.

A 2023 study looked at a single-capsule bismuth-based regimen as second-line therapy in patients whose earlier treatment had failed. The European Hp-EuReg registry summarised several years of data on the use and safety of these regimens. The data cover several years of routine practice.

Reviews and consensus documents, the Toronto Consensus among them, list bismuth quadruple therapy among recommended options. They also note that resistance of the bacterium to antibacterials differs between regions, so the choice of regimen stays with a physician.

Published research

Primary sources, verified against PubMed:

• Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days., PubMed 38700630 (Digestive diseases and sciences, 2024).
• Single-capsule bismuth-based quadruple therapy as a rescue therapy for Helicobacter pylori eradication., PubMed 36189844 (Scandinavian journal of gastroenterology, 2023).
• Evolution of the use, effectiveness and safety of bismuth-containing quadruple therapy for Helicobacter pylori infection between 2013 and 2021: results from the European registry on H. pylori management (Hp-EuReg)., PubMed 39461739 (Gut, 2024).
• The Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults., PubMed 27102658 (Gastroenterology, 2016).

Listed for reference. Publication of a study is not a claim about this particular product.

Precautions

• This is a prescription medicine. Prescribing, the regimen and checking the result belong to a gastroenterologist.
• It is not used in pregnancy or breastfeeding, in children under 12, or in severe liver and kidney impairment.
• It is contraindicated in hypersensitivity to bismuth subcitrate potassium, metronidazole, tetracycline or other components.
• Darkening of the stool and tongue, nausea, diarrhoea, a metallic taste, headache and abdominal pain are possible.
• Rare severe reactions have been described: encephalopathy, liver injury, skin reactions, aseptic meningitis and peripheral neuropathy.
• Alcohol is usually avoided during and after treatment: metronidazole with alcohol causes an intolerable reaction.
• Tell your doctor about every other medicine you take: interactions with other drugs are possible.

Frequently asked