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Drug Interactions between Flomax and mirabegron

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

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Interactions between your drugs

Moderate

tamsulosin mirabegron

Applies to: Flomax (tamsulosin) and mirabegron

MONITOR: Coadministration with mirabegron may increase the plasma concentrations of tamsulosin. The proposed mechanism is mirabegron inhibition of tamsulosin metabolism via CYP450 2D6 and 3A4. In healthy study subjects, tamsulosin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by more than 50% when a single 0.4 mg dose of tamsulosin was administered following multiple dosing of mirabegron 100 mg daily. In contrast, mirabegron Cmax and AUC decreased by approximately 20% when a single 100 mg dose of mirabegron was administered following multiple dosing of tamsulosin 0.4 mg daily.

MANAGEMENT: No dosage adjustment is recommended when tamsulosin is coadministered with mirabegron. However, caution is advised, particularly when tamsulosin is prescribed at a dosage higher than 0.4 mg/day. The potential for increased risk of adverse effects such as postural hypotension, syncope, and priapism should be considered. Patients should be advised to avoid rising abruptly from a sitting or recumbent position, and to notify their physician if they experience dizziness, lightheadedness, syncope, orthostasis, or tachycardia. Patients should also avoid driving or operating hazardous machinery until they know how the medications affect them.

References

  1. (2012) "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc

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Drug and food interactions

Moderate

tamsulosin food

Applies to: Flomax (tamsulosin)

ADJUST DOSING INTERVAL: Food may delay the gastrointestinal absorption of tamsulosin. The time to maximum plasma concentration (Tmax) is reached by 4 to 5 hours under fasted conditions and by 6 to 7 hours when tamsulosin is administered with food. The delay in Tmax has the desirable effect of smoothing the tamsulosin plasma concentration profile, thereby reducing fluctuation of the plasma peak and trough concentrations with multiple dosing. Food may also affect the extent of absorption of tamsulosin. It has been reported that taking tamsulosin under fasted conditions results in a 30% increase in bioavailability (AUC) and 40% to 70% increase in peak plasma concentration (Cmax) compared to fed conditions. The effects of food on the pharmacokinetics of tamsulosin are consistent regardless of whether tamsulosin is taken with a light meal or a high-fat meal.

MANAGEMENT: To ensure uniformity of absorption, tamsulosin should be administered approximately one-half hour following the same meal each day.

References

  1. (2001) "Product Information. Flomax (tamsulosin)." Boehringer-Ingelheim

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Minor

mirabegron food

Applies to: mirabegron

Food reduces the oral absorption and bioavailability of mirabegron. According to the product labeling, administration of a 50 mg tablet with a high-fat meal decreased mirabegron peak plasma concentration (Cmax) and systemic exposure (AUC) by 45% and 17%, respectively, whereas administration with a low-fat meal decreased mirabegron Cmax and AUC by 75% and 51%, respectively. In phase 3 clinical studies demonstrating both safety and efficacy, mirabegron was administered without regards to food content and intake. Therefore, mirabegron can be taken with or without food at the recommended dosage.

References

  1. (2012) "Product Information. Myrbetriq (mirabegron)." Astellas Pharma US, Inc

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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.

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