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Drug Interactions between omeprazole and Pylera

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

tetracycline bismuth subcitrate potassium

Applies to: Pylera (bismuth subcitrate potassium / metronidazole / tetracycline) and Pylera (bismuth subcitrate potassium / metronidazole / tetracycline)

Using bismuth subcitrate potassium together with tetracycline may decrease the effects of tetracycline. Administration of tetracycline and bismuth subcitrate potassium should be separated by two to three hours. If your doctor does prescribe these medications together, you may need a dose adjustment or special test to safely use both medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Moderate

omeprazole bismuth subcitrate potassium

Applies to: omeprazole and Pylera (bismuth subcitrate potassium / metronidazole / tetracycline)

Consumer information for this interaction is not currently available.

MONITOR: Coadministration with proton pump inhibitors or H2-receptor antagonists may significantly increase the gastrointestinal absorption of bismuth from bismuth subcitrate potassium (also known as colloidal bismuth subcitrate or tripotassium dicitratobismuthate), a process that appears to be dependent on intragastric pH. In a study conducted in six healthy volunteers, administration of omeprazole 40 mg/day orally for 1 week increased mean bismuth peak plasma concentration (Cmax) and systemic exposure (AUC) from a single 240 mg dose of bismuth subcitrate potassium by 136% and 274%, respectively, compared to placebo. The magnitude of these changes correlated with the degree of hypochlorhydria. The study also reported that plasma levels of bismuth were sometimes briefly over the "toxic" threshold of 100 mcg/L, although the clinical relevance of this observation following more prolonged dosing is uncertain. In another study conducted in 12 healthy volunteers, ranitidine 300 mg given orally for two doses 9 hours apart increased the median bismuth Cmax and 8-hour AUC from a single 240 mg dose of bismuth subcitrate potassium by 95% and 141%, respectively, compared to placebo. These increases were not caused by changes in renal bismuth clearance. By contrast, pretreatment with ranitidine had no significant effects on plasma bismuth exposures from single doses of bismuth subsalicylate and bismuth subnitrate, with very little systemic absorption of bismuth either with or without ranitidine pretreatment despite both formulations containing considerable amounts of bismuth. Previous studies have also reported on the limited systemic absorption of bismuth from these salts. When Pylera (a treatment preparation for Helicobacter pylori infection that contains bismuth subcitrate potassium 420 mg, metronidazole 375 mg, and tetracycline 375 mg per recommended dose) was administered four times daily with omeprazole 20 mg orally twice daily for 6 days in 34 healthy volunteers, mean bismuth Cmax and AUC increased by 215% and 191%, respectively, compared to administration without omeprazole. Concentration-dependent neurotoxicity has been associated with long-term use of bismuth; however, it is unlikely to occur with short-term administration or steady-state blood concentrations below 50 ng/mL. In the study, one subject transiently achieved a bismuth Cmax higher than 50 ng/mL (73 ng/mL) following multiple dosing of Pylera with omeprazole but did not exhibit symptoms of neurotoxicity. According to the manufacturer, there is no clinical evidence to suggest that short-term exposure to bismuth Cmax concentrations above 50 ng/mL is associated with neurotoxicity.

MANAGEMENT: Caution is advised when bismuth subcitrate potassium is used concomitantly with proton pump inhibitors or H2-receptor antagonists. Since food is known to impair the gastrointestinal absorption of bismuth, some authorities recommend taking this combination with food to minimize the potential risk of bismuth toxicity. Additionally, the increased gastric retention time of bismuth in the presence of food may be clinically beneficial, as it likely prolongs the exposure of Helicobacter pylori to high concentrations of bismuth.

Drug and food interactions

Major

metroNIDAZOLE food

Applies to: Pylera (bismuth subcitrate potassium / metronidazole / tetracycline)

Consumption of alcoholic beverages or products containing alcohol or propylene glycol during treatment with metroNIDAZOLE is not recommended. Doing so may occasionally trigger a reaction in some patients similar to the disulfiram reaction, which includes unpleasant effects such as flushing, throbbing in head and neck, throbbing headache, difficulty breathing, nausea, vomiting, sweating, thirst, chest pain, rapid heartbeat, palpitation, low blood pressure, dizziness, lightheadedness, blurred vision, and confusion. Rarely, more severe reactions may include abnormal heart rhythm, heart attack, heart failure, unconsciousness, convulsions, and even death. Patients treated with metroNIDAZOLE should continue to avoid using any products containing alcohol or propylene glycol for at least 3 days until after completion of therapy. Talk to your doctor or pharmacist if you have questions on how to take this or other medications you are prescribed. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Moderate

tetracycline food

Applies to: Pylera (bismuth subcitrate potassium / metronidazole / tetracycline)

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking tetracycline. These products can make tetracycline less effective in treating your infection. Do not take tetracycline with milk or other dairy products, unless your doctor has told you to. Dairy products can make it harder for your body to absorb the medication.

Moderate

bismuth subcitrate potassium food

Applies to: Pylera (bismuth subcitrate potassium / metronidazole / tetracycline)

Consumer information for this interaction is not currently available.

ADJUST DOSING INTERVAL: Food may impair the gastrointestinal absorption and decrease the bioavailability of bismuth from the administration of bismuth subcitrate potassium (also known as colloidal bismuth subcitrate or tripotassium dicitratobismuthate). The clinical significance of this effect is unknown, as the relative importance of systemic versus local bismuth concentrations for antimicrobial activity against Helicobacter pylori has not been established. Investigators have suggested that the increased gastric retention time of bismuth in the presence of food may be beneficial by prolonging the local exposure of Helicobacter pylori to high concentrations of bismuth, although the amount of bismuth absorbed systemically and secreted back into the gastric fluid may also contribute to its therapeutic effect. When Pylera (a treatment preparation for Helicobacter pylori infection that contains bismuth subcitrate potassium 420 mg, metronidazole 375 mg, and tetracycline 375 mg per recommended dose) was administered after a standardized high-fat breakfast in 23 healthy volunteers, mean systemic exposure (AUC) for bismuth decreased by 60% compared to administration in the fasting state. Metronidazole and tetracycline AUC values were also reduced by 6% and 34%, respectively. However, these changes are not deemed clinically relevant, as eradication rates of Helicobacter pylori near 90% have been reported in trial patients administered Pylera routinely after meals.

MANAGEMENT: Pylera and generic equivalents should be administered after meals (breakfast, lunch, and dinner) and at bedtime (preferably with a snack). The manufacturers for some of the other bismuth subcitrate potassium products have recommended avoiding the ingestion of food, beverages, or other medications within one-half hour before and after each dose. The prescribing information or package labeling should be consulted for dosing and administration instructions that are appropriate for each product.

Moderate

tetracycline food

Applies to: Pylera (bismuth subcitrate potassium / metronidazole / tetracycline)

Iron can bind to tetracycline in the gastrointestinal tract, which may prevent their absorption into the bloodstream and possibly reduce their effectiveness. To avoid or minimize the interaction, iron-containing medications and tetracycline should preferably be taken at least three to four hours apart in most cases. Talk to your doctor if you have any questions or concerns, or if you have trouble separating the dosing times. Your doctor may be able to prescribe alternatives that do not interact. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.