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Drug Interactions between macitentan / tadalafil and trospium / xanomeline

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

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Interactions between your drugs

Moderate

tadalafil xanomeline

Applies to: macitentan / tadalafil and trospium / xanomeline

MONITOR: Xanomeline may increase the concentration of sensitive oral CYP450 3A4 substrates and/or narrow therapeutic index (NTI) oral P-glycoprotein (P-gp) substrates. In vitro data suggest that xanomeline may transiently inhibit CYP450 3A4 and P-gp locally in the intestine after dosing. Xanomeline does not appear to inhibit CYP450 3A4 and/or P-gp systemically. Clinical data evaluating this interaction are not available.

MANAGEMENT: Caution and clinical monitoring are advised if xanomeline is used in combination with an orally administered CYP450 3A4 sensitive substrate and/or NTI P-gp substrate for which a small change in substrate plasma concentration could lead to serious toxicities. The labeling of the substrate may be consulted for specific monitoring and dose adjustment recommendations should adverse reactions result from this combination.

References (1)
  1. (2024) "Product Information. Cobenfy (trospium-xanomeline)." Bristol-Myers Squibb

Drug and food interactions

Moderate

tadalafil food

Applies to: macitentan / 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 (2)
  1. (2003) "Product Information. Cialis (tadalafil)." Lilly, Eli and Company
  2. (2009) "Product Information. Adcirca (tadalafil)." United Therapeutics Corporation
Moderate

trospium food

Applies to: trospium / xanomeline

ADJUST DOSING INTERVAL: Food may reduce the oral absorption and bioavailability of trospium chloride. According to the product labeling, administration of trospium chloride with a high fat meal reduced the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) by 70% to 80% compared to administration while fasting.

MANAGEMENT: To ensure maximal oral absorption, trospium chloride should be administered at least 1 hour before meals or on an empty stomach. If trospium chloride is administered as a combination with xanomeline, the manufacturer recommends administering the capsules at least 1 hour before a meal or at least 2 hours after a meal. Capsules should be taken whole.

References (5)
  1. (2012) "Product Information. Sanctura (trospium)." Odyssey Pharmaceuticals
  2. (2024) "Product Information. Cobenfy (trospium-xanomeline)." Bristol-Myers Squibb
  3. (2019) "Product Information. Trosec (trospium)." Oryx Pharmaceuticals Inc
  4. (2022) "Product Information. Regurin (trospium)." Mylan Healthcare Sdn. Bhd.
  5. (2023) "Product Information. Trospium Chloride (trospium)." Padagis

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.