Pylori

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Basic Information:

This medicine is used to eradication of Helicobacter pylori and prevention of relapse of peptic ulcer disease when administered in co-prescription with appropriate antibiotic(s).

Detailed Information:

Contraindications
Pylorid tablets are contra-indicated in patients known to have hypersensitivity to any of the ingredients.

Pylorid is contra-indicated for long-term (maintenance) therapy.

As with other bismuth-containing drugs, Pylorid should not be used in patients with moderate to severe renal impairment (i.e., creatinine clearance typically <25 mL/min).

Special warnings and precautions for use
The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer, as treatment with Pylorid tablets may mask symptoms of gastric carcinoma.

Pylorid tablets should be avoided in patients with a history of acute porphyria.

When co-prescription with antibiotic(s) is clinically indicated, the relevant prescribing information should be consulted prior to initiation of therapy.

Interaction with other medicinal products and other forms of Interaction
An increase in median trough plasma bismuth concentrations has been observed when Pylorid is co-administered with clarithromycin, however, this has not been associated with any adverse clinical sequelae in clinical trials. This increase was not observed in clinical studies in patients receiving 7-day triple therapy with Pylorid, clarithromycin and either metronidazole or amoxycillin. Clarithromycin levels are unaffected by the administration of ranitidine bismuth citrate, although systemic exposure to the active metabolite of clarithromycin is increased. The ranitidine absorption from Pylorid tablets is increased when co-administered with clarithromycin. This enhanced ranitidine exposure is of no clinical concern due to the wide therapeutic index of ranitidine.

Food causes a decrease in bismuth absorption which is not of any clinical relevance. Limited data suggest increased ulcer healing when Pylorid tablets are administered with food. (See Section 4.2 Posology).

The co-administration of antacids with Pylorid tablets does not result in any clinically relevant effect.

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