Drug Interactions between dabigatran and Prilosec OTC

MONITOR: Patients with gastrointestinal conditions may have an increased risk of gastrointestinal bleeding during concomitant treatment with dabigatran etexilate and proton pump inhibitors or H2 blockers. In addition, pantoprazole resulted in an approximately 30% decrease in dabigatran systemic exposure (AUC). Diminished clinical effect may occur, although no dosage adjustment is recommended for dabigatran etexilate. The pharmacokinetics of pantoprazole were not significantly altered by dabigatran. Pantoprazole and other proton pump inhibitors were also coadministered with dabigatran in clinical trials for the prevention of venous thromboembolic events after hip- or knee-replacement surgery, and no effects on bleeding or efficacy were observed. Ranitidine had no significant effects on the absorption of dabigatran.

MANAGEMENT: Patients should be monitored for signs of gastrointestinal bleeding and advised to promptly report any symptoms to their physician, such as abdominal pain, dizziness, lightheadedness, vomiting blood, anorexia, and/or black, tarry stools.