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Drug Interactions between fluconazole and ospemifene

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

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Interactions between your drugs

Major

fluconazole ospemifene

Applies to: fluconazole and ospemifene

GENERALLY AVOID: Coadministration with fluconazole may significantly increase the plasma concentrations of ospemifene. The proposed mechanism is fluconazole inhibition of ospemifene metabolism via CYP450 3A4, 2C9, and 2C19. In 14 postmenopausal women given fluconazole 400 mg once followed by 200 mg daily for a total duration of 8 days, administration of ospemifene 60 mg after breakfast on day 5 of fluconazole treatment resulted in 1.7- and 2.7-fold increases in ospemifene peak plasma concentration (Cmax) and systemic exposure (AUC), respectively, compared to administration of ospemifene alone. Increased risk of adverse events such as hot flush, thromboembolism, and endometrial or breast cancer may occur.

MANAGEMENT: Ospemifene should not be prescribed in combination with fluconazole.

References (1)
  1. (2013) "Product Information. Osphena (ospemifene)." Shionogi USA Inc

Drug and food interactions

Moderate

ospemifene food

Applies to: ospemifene

ADJUST DOSING INTERVAL: Food significantly enhances the oral bioavailability of ospemifene. In a cross-study comparison, administration of a single 60 mg dose of ospemifene with a high-fat/high-calorie meal (860 kcal) in postmenopausal women increased ospemifene peak plasma concentration (Cmax) and systemic exposure (AUC) by 2.3- and 1.7-fold, respectively, compared to administration under fasted condition. Elimination half-life and time to maximum concentration (Tmax) were not altered. In two separate food effect studies where different ospemifene tablet formulations were given to healthy male volunteers, ospemifene Cmax and AUC increased by 2.3- and 1.8-fold, respectively, with a low-fat/low-calorie meal (300 kcal) and 3.6- and 2.7-fold, respectively, with a high-fat/high-calorie meal (860 kcal) relative to fasting.

MANAGEMENT: Ospemifene should be taken once daily with food.

References (1)
  1. (2013) "Product Information. Osphena (ospemifene)." Shionogi USA Inc

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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