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Pylera: Uses, Dosage and Side Effects
Pylera is a prescription combination medication used to treat Helicobacter pylori infections. It contains three active ingredients and is always used alongside a proton pump inhibitor.
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Pylera is a prescription combination medication used to treat Helicobacter pylori infections. It contains three active ingredients and is always used alongside a proton pump inhibitor.
What is Pylera?
Pylera is a prescription medication used for the eradication (elimination) of Helicobacter pylori. Helicobacter pylori (H. pylori) is a bacterium that can colonize the stomach lining and cause various gastric conditions, including stomach ulcers and chronic gastric inflammation. Pylera is available as a capsule and must always be used in combination with a proton pump inhibitor (PPI) such as omeprazole.
Active Ingredients and Composition
Each Pylera capsule contains three active ingredients:
- Bismuth subcitrate potassium (140 mg): A bismuth-containing salt with antibacterial properties that also protects the stomach lining.
- Metronidazole (125 mg): An antibiotic and antiprotozoal agent effective against a wide range of bacteria and parasites.
- Tetracycline (125 mg): A broad-spectrum antibiotic that inhibits bacterial growth.
Mechanism of Action
The three active ingredients in Pylera work together to target H. pylori from different angles:
- Bismuth subcitrate potassium damages the bacterial cell wall, inhibits bacterial enzymes, and prevents the bacteria from adhering to the stomach lining.
- Metronidazole penetrates the bacterial cell and damages its DNA, causing cell death.
- Tetracycline inhibits bacterial protein synthesis, preventing the bacteria from multiplying.
The additionally prescribed proton pump inhibitor reduces stomach acid, creating an environment in which the antibiotics can work more effectively.
Indications and Uses
Pylera is approved for the treatment of Helicobacter pylori infections in adults, in combination with a proton pump inhibitor. It is used for:
- Stomach ulcers (gastric ulcer) and duodenal ulcers caused by H. pylori
- Chronic inflammation of the stomach lining (chronic gastritis) associated with H. pylori
- Cases where first-line therapy (e.g., clarithromycin-based triple therapy) has failed
Dosage and Administration
The standard recommended dose is:
- 3 Pylera capsules four times daily (after meals and at bedtime)
- Plus 1 capsule of omeprazole 20 mg (or another PPI) twice daily
- The typical treatment duration is 10 days
Capsules should be taken with a full glass of water (at least 240 ml) to minimize the risk of esophageal irritation caused by tetracycline. Alcohol must be avoided during treatment, as metronidazole can cause a severe reaction when combined with alcohol.
Side Effects
Like all medicines, Pylera can cause side effects. Commonly reported side effects include:
- Darkening of stools (due to bismuth; harmless)
- Nausea, vomiting, and diarrhea
- Abdominal pain and loss of appetite
- Headache and dizziness
- Dark-colored urine (due to metronidazole)
- Skin sensitivity to sunlight (due to tetracycline)
Rare but serious side effects may include allergic reactions, liver damage, or neurological symptoms. Medical advice should be sought immediately if severe or persistent symptoms occur.
Contraindications
Pylera must not be used in patients with:
- Known hypersensitivity to any of the active ingredients
- Severe kidney or liver impairment
- Pregnancy or breastfeeding (tetracycline can impair bone development in the child)
- Children and adolescents under 18 years of age
Drug Interactions
Pylera can interact with other medications. Important interactions include:
- Alcohol: Concurrent use can cause flushing, nausea, and vomiting (metronidazole effect).
- Antacids, iron, or calcium supplements: These reduce the absorption of tetracycline and should be taken at a different time.
- Blood thinners (e.g., warfarin): Metronidazole may enhance the effect of anticoagulants.
- Dairy products: Can reduce the absorption of tetracycline.
References
- European Medicines Agency (EMA) - Product Information for Pylera, last updated 2023. Available at: https://www.ema.europa.eu
- Malfertheiner P. et al. - Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut, 2022; 71(9): 1724-1762.
- Chey W.D. et al. - ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. American Journal of Gastroenterology, 2017; 112(2): 212-239.
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