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Drug Interactions between Cialis and simeprevir

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

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Interactions between your drugs

Moderate

tadalafil simeprevir

Applies to: Cialis (tadalafil) and simeprevir

MONITOR: Coadministration with simeprevir may result in mild increases in plasma concentrations of phosphodiesterase-5 (PDE5) inhibitors, which are primarily metabolized by CYP450 3A4. In vivo, simeprevir mildly inhibits intestinal CYP450 3A4, but does not affect hepatic CYP450 3A4 activity. Therefore, a major pharmacokinetic interaction is not expected under normal circumstances.

MANAGEMENT: When prescribed with simeprevir, no empiric dosage adjustment is required for PDE5 inhibitors in the treatment of erectile dysfunction. However, dosage adjustment of sildenafil or tadalafil may be needed when these agents are administered chronically for the treatment of pulmonary arterial hypertension. Consider starting with the lowest effective dose and increase as needed, with clinical monitoring as appropriate.

References

  1. (2013) "Product Information. Olysio (simeprevir)." Janssen Pharmaceuticals

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Drug and food interactions

Moderate

tadalafil food

Applies to: Cialis (tadalafil)

GENERALLY AVOID: Additive hypotensive effects may occur when phosphodiesterase-5 (PDE5) inhibitors such as tadalafil are used with alcohol, as both are mild systemic vasodilators. In clinical pharmacology studies, more subjects administered alcohol at a dose of 0.7 g/kg (equivalent to approximately 6 ounces of 80-proof vodka in an 80-kg male; consumed within 10 minutes in study subjects, providing blood alcohol levels of 0.08%) in combination with tadalafil 10 or 20 mg single doses had clinically significant decreases in blood pressure than with alcohol alone. There were reports of postural dizziness, and orthostatic hypotension was observed in some. When tadalafil 20 mg was administered with alcohol at a lower dose of 0.6 g/kg (equivalent to approximately 4 ounces of 80-proof vodka in an 80-kg male), orthostatic hypotension was not observed, dizziness occurred with similar frequency relative to alcohol alone, and the hypotensive effects of alcohol were not potentiated. Neither tadalafil nor alcohol affected the plasma concentrations of the other.

GENERALLY AVOID: Coadministration with grapefruit juice is likely to increase the plasma concentrations of tadalafil, which is primarily metabolized by CYP450 3A4. However, the interaction has not been studied. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit.

MANAGEMENT: Patients taking tadalafil should avoid consuming large amounts of alcohol (for example, 5 units or more), which may increase the potential for orthostatic signs and symptoms including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. It may also be appropriate to avoid consuming large amounts of grapefruit juice.

References

  1. (2003) "Product Information. Cialis (tadalafil)." Lilly, Eli and Company
  2. (2009) "Product Information. Adcirca (tadalafil)." United Therapeutics Corporation

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Moderate

simeprevir food

Applies to: simeprevir

ADJUST DOSING INTERVAL: Food significantly enhances the oral bioavailability of simeprevir, although the type of food does not seem to matter. In healthy study subjects, administration of simeprevir after a high-fat, high-caloric (928 kcal) breakfast increased systemic exposure (AUC) by 61% and delayed absorption by 1 hour, while administration after a normal caloric (533 kcal) breakfast increased AUC by 69% and delayed absorption by 1.5 hours.

MANAGEMENT: To ensure maximal oral absorption, simeprevir should be administered with food.

References

  1. (2013) "Product Information. Olysio (simeprevir)." Janssen Pharmaceuticals

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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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