Bismuth subcitrate/metronidazole/tetracycline

The drug combination bismuth subcitrate/metronidazole/tetracycline (trade name Pylera) is used for the treatment of peptic ulcer with an infection by the bacterium Helicobacter pylori.[1] It is taken by mouth.[1]

Bismuth subcitrate/metronidazole/tetracycline
Combination of
Bismuth subcitrateBismuth salt
MetronidazoleNitroimidazole antimicrobial
TetracyclineTetracycline class antimicrobial
Clinical data
Trade namesPylera
AHFS/Drugs.comProfessional Drug Facts
License data
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none

It is available as a generic medication.[2]

Medical uses

This combination is used together with omeprazole as a 'quadruple therapy' for the eradication of H. pylori and for preventing peptic ulcers that are caused by this bacterium.[3]

Contraindications

The drug must not be taken by pregnant women, because tetracycline is known to cause tooth and bone defects in unborn children. It is also contraindicated in breastfeeding women, children up to 12 years of age, and by patients with impaired liver or renal (kidney) function, because no studies in such persons have been conducted. Tetracycline is also likely to be harmful in liver patients.[3]

Adverse effects

Common side effects include diarrhoea, nausea and dysgeusia (distortion of the sense of taste), especially a metallic taste. These effects are known from the drug's components as well as from other antibiotics. A very rare but dangerous reaction is Stevens–Johnson syndrome, a life-threatening condition affecting the skin, which has also been described under metronidazole and tetracycline as separate drugs.[3]

Interactions
Further information: Bismuth subcitrate § Interactions, and Metronidazole § Drug interactions

Metronidazole in combination with alcohol causes severe reactions such as vomiting and flushes in many patients. Tetracycline resorption is reduced by dairy products, antacids and other products containing calcium, magnesium, aluminium as well as iron.[3]

Mechanism of action
Further information: Bismuth subcitrate § Mechanism of action, Metronidazole § Mechanism of action, and Tetracycline § Mechanism of action

Chemical properties

Bismuth subcitrate potassium is a salt of bismuth (Bi3+), potassium (K+) and citrate (C6H5O73−), containing about 25.6% (mass percent) bismuth, which is the active moiety, and 22.9% potassium. Tetracycline is contained as the hydrochloride, and metronidazole as the pure substance.[3]

References
  1. "Pylera- bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride capsule". DailyMed. Retrieved 5 October 2021.
  2. "First Generic Drug Approvals 2023". U.S. Food and Drug Administration (FDA). 30 May 2023. Archived from the original on 30 June 2023. Retrieved 30 June 2023.
  3. Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. 2017. Pylera 140 mg/125 mg/125 mg-Hartkapseln.
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