PRADAXA (Brand for DABIGATRAN ETEXILATE)

Dabigatran etexilate 150mg, Oral capsule

Grapefruit juice

· Severity: Moderate

· Notes for Consumers: Although an interaction is possible, this combination may be used together by most patients. If you have kidney problems, do not drink grapefruit juice while taking this medicine without talking to your healthcare provider. Taking this medicine with grapefruit juice together may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding. Signs of bleeding may include increased bruising, pinpoint red spots on your skin, nosebleeds, bleeding gums, blood in the urine, or black, tarry stools.

· Notes for Professionals: Increased serum concentrations of dabigatran are possible when dabigatran, a P-glycoprotein (P-gp) substrate, is coadministered with grapefruit juice, a P-gp inhibitor. Patients should be monitored for increased adverse effects of dabigatran. When dabigatran is administered for treatment or reduction in risk of recurrence of deep venous thrombosis (DVT) or pulmonary embolism (PE), avoid coadministration with P-gp inhibitors like grapefruit juice in patients with CrCl < 50 ml/min. When dabigatran is used in patients with non-valvular atrial fibrillation and severe renal impairment (CrCl < 30 ml/min), avoid coadministration with grapefruit juice, as serum concentrations of dabigatran are expected to be higher than when administered to patients with normal renal function. P-gp inhibition and renal impairment are the major independent factors that result in increased exposure to dabigatran.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>