Interação entre Fluconazol e Tolvaptana

…dominant polycystic kidney disease (ADPKD) outside of FDA-approved REMS [see Warnings and Precautions (5.2) ] Unable to sense or respond to thirst Hypovolemic hyponatremia Taking strong CYP3A inhibitors [see Warnings and Precautions (5.5) ] Anuria Hypersensitivity (e.g., anaphylactic shock, rash generalized) to tolvaptan or any components of the product [see Adverse…

Concomitant use of strong CYP3A inhibitors ( 4 )

Avoid use with moderate to strong CYP3A inhibitors ( 5.5 )

Do not use SAMSCA with strong inhibitors of CYP3A [see Contraindications (4) ] and avoid concomitant use with moderate CYP3A inhibitors.

Avoid concomitant use with: Moderate CYP3A inhibitors ( 7.1 )

(See CLINICAL PHARMACOLOGY: Drug Interaction Studies . ) Tolvaptan Plasma exposure to tolvaptan is significantly increased (200% in AUC; 80% in C max ) when tolvaptan, a CYP3A4 substrate, is coadministered with fluconazole, a moderate CYP3A4 inhibitor.

This interaction may result in the risk of a significant increase in adverse reactions associated with tolvaptan, particularly significant diuresis, dehydration and acute renal failure.

If tolvaptan and fluconazole are concomitantly administered, the tolvaptan dose should be reduced as instructed in the tolvaptan prescribing information and the patient should be frequently monitored for any adverse reactions associated with tolvaptan.