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Drug Interactions between clofazimine and tolvaptan

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

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Interactions between your drugs

Major

clofazimine tolvaptan

Applies to: clofazimine and tolvaptan

GENERALLY AVOID: Coadministration with moderate inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of tolvaptan. According to the prescribing information, tolvaptan is extensively metabolized in the liver almost exclusively by CYP450 3A4. Tolvaptan peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 80% and 200%, respectively, when the moderate CYP450 3A4 inhibitor fluconazole was given in a 400 mg dose one day prior and a 200 mg dose concomitantly with tolvaptan.

MANAGEMENT: Concomitant use of tolvaptan with moderate CYP450 3A4 inhibitors should generally be avoided. A 50% reduction of the total daily tolvaptan dosage is recommended when used in the treatment of adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD), along with close monitoring of serum sodium and volume status. The prescribing information for both the specific tolvaptan product and the concomitant medication should be consulted for more detailed guidance.

References (7)
  1. (2009) "Product Information. Samsca (tolvaptan)." Otsuka American Pharmaceuticals Inc
  2. (2022) "Product Information. Samsca (tolvaptan)." Otsuka American Pharmaceuticals Inc
  3. (2019) "Product Information. Samsca (tolvaptan)." Otsuka Canada Pharmaceutical Inc
  4. (2021) "Product Information. Samsca (tolvaptan)." Otsuka Australia Pharmaceutical Pty Ltd
  5. (2022) "Product Information. Jynarque (tolvaptan)." Otsuka American Pharmaceuticals Inc
  6. (2019) "Product Information. Jinarc (tolvaptan)." Otsuka Pharmaceutical Co Ltd
  7. (2022) "Product Information. Jinarc (tolvaptan)." Otsuka Australia Pharmaceutical Pty Ltd

Drug and food interactions

Moderate

tolvaptan food

Applies to: tolvaptan

GENERALLY AVOID: Grapefruit juice may significantly increase the plasma concentrations of tolvaptan. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits. According to the product labeling, administration of tolvaptan with grapefruit juice resulted in a 1.8-fold increase in tolvaptan systemic exposure. The clinical significance is unknown, although increased pharmacologic effects may be expected. Too rapid correction of hyponatremia increases the risk of osmotic demyelination syndrome, which is associated with dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, and death.

MANAGEMENT: Patients treated with tolvaptan should avoid consumption of grapefruits and grapefruit juice.

References (1)
  1. (2009) "Product Information. Samsca (tolvaptan)." Otsuka American Pharmaceuticals 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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