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Caution should be exercised when prescribing or up titrating ranolazine to patients in whom an increased exposure is expected: Concomitant administration of moderate CYP3A4 inhibitors.
Concomitant administration of P-gp inhibitors.
Mild hepatic impairment.
Mild to moderate renal impairment (creatinine clearance 3080 ml/min).
Patients with low weight (60 kg).
Patients with moderate to severe CHF (NYHA Class III-IV).
The risk for increased exposure leading to adverse events in these different subgroups is higher in patients lacking CYP2D6 activity (poor metabolisers, PM) than subjects with CYP2D6 metabolising capacity (extensive metabolisers, EM). Renal function decreases with age and it is therefore important to check renal function at regular intervals during treatment with ranolazine. Caution should be observed when treating patients with a history of congenital or a family history of long QT syndrome, in patients with known acquired QT interval prolongation, and in patients treated with drugs affecting the QTc interval.
