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Drug Interactions between Cialis and mibefradil

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

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Interactions between your drugs

Major

mibefradil tadalafil

Applies to: mibefradil and Cialis (tadalafil)

ADJUST DOSE: Coadministration with drugs that are potent inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of tadalafil, which is primarily metabolized by the isoenzyme. According to the product labeling for tadalafil, ketoconazole (400 mg daily), a selective and potent inhibitor of CYP450 3A4, increased the peak plasma concentration (Cmax) and systemic exposure (AUC) of a single 20 mg dose of tadalafil by 22% and 312%, respectively, compared to administration of tadalafil alone. Ketoconazole (200 mg daily) increased the Cmax and AUC of a single 10 mg dose of tadalafil by 15% and 107%, respectively. Ritonavir (200 mg twice a day), another potent inhibitor of CYP450 3A4, increased the AUC of a single 20 mg dose of tadalafil by 124% with no change in Cmax.

MANAGEMENT: Concomitant use of tadalafil with potent 3A4 inhibitors is not recommended in patients being treated for pulmonary arterial hypertension or for benign prostatic hyperplasia (BPH). In addition, some authorities recommend avoiding concomitant use of tadalafil during and for 2 weeks after treatment with itraconazole in patients with pulmonary arterial hypertension. For erectile dysfunction, tadalafil labeling recommends that the dosage not exceed 10 mg once every 72 hours when taken on an as needed basis in patients treated concomitantly with a potent CYP450 3A4 inhibitor. When taken on a daily basis, the dose should not exceed 2.5 mg per day. Patients should be advised to promptly notify their physician if they experience pain or tightness in the chest or jaw, irregular heartbeat, nausea, shortness of breath, visual disturbances, syncope, or prolonged erection (greater than 4 hours).

References

  1. "Product Information. Sporanox (itraconazole)." Janssen Pharmaceuticals PROD (2002):
  2. "Product Information. Cialis (tadalafil)." Lilly, Eli and Company (2003):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Adcirca (tadalafil)." United Therapeutics Corporation (2009):
  5. "Product Information. Entadfi (finasteride-tadalafil)." Veru Inc (2021):
View all 5 references

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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. "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

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

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