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Drug Interactions between bosentan and tadalafil

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

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Interactions between your drugs

Moderate

bosentan tadalafil

Applies to: bosentan and tadalafil

MONITOR: Coadministration with inducers of CYP450 3A4 may decrease the plasma concentrations of tadalafil, which is primarily metabolized by the isoenzyme. Rifampin (600 mg daily), a potent CYP450 3A4 inducer, has been reported to decrease tadalafil peak plasma concentration (Cmax) and systemic exposure (AUC) from a single 10 mg dose by 46% and 88%, respectively, compared to administration of the drug alone.

MANAGEMENT: For the treatment of benign prostatic hyperplasia and erectile dysfunction, no dosage adjustment of tadalafil is warranted during coadministration with CYP450 3A4 inducers. However, the possibility of diminished pharmacologic effects of tadalafil should be considered. For the treatment of pulmonary arterial hypertension, use of tadalafil should be avoided in patients chronically taking potent inducers of CYP450 3A4.

References

  1. "Product Information. Cialis (tadalafil)." Lilly, Eli and Company (2003):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Adcirca (tadalafil)." United Therapeutics Corporation (2009):

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Drug and food interactions

Moderate

tadalafil food

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

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Therapeutic duplication warnings

Therapeutic duplication is the use of more than one medicine from the same drug category or therapeutic class to treat the same condition. This can be intentional in cases where drugs with similar actions are used together for demonstrated therapeutic benefit. It can also be unintentional in cases where a patient has been treated by more than one doctor, or had prescriptions filled at more than one pharmacy, and can have potentially adverse consequences.

Duplication

Agents for pulmonary hypertension

Therapeutic duplication

The recommended maximum number of medicines in the 'agents for pulmonary hypertension' category to be taken concurrently is usually one. Your list includes two medicines belonging to the 'agents for pulmonary hypertension' category:

  • bosentan
  • tadalafil

Note: In certain circumstances, the benefits of taking this combination of drugs may outweigh any risks. Always consult your healthcare provider before making changes to your medications or dosage.


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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.