Drug Interactions between dabigatran and Picot Plus

MONITOR CLOSELY: Aspirin (ASA; acetylsalicylic acid ) may potentiate the risk of bleeding in patients treated with dabigatran etexilate. The pharmacologic effects of ASA that contribute to this interaction include prolongation of prothrombin time and inhibition of platelet adhesion and aggregation. Aspirin at dosages of 81 to 325 mg daily has been shown to increase the risk of bleeding when given concomitantly with dabigatran etexilate at dosages above 220 mg/day. In a phase 3 clinical trial of dabigatran etexilate for the prevention of stroke and systemic embolism in patients with atrial fibrillation, coadministration of oral antiplatelet agents including ASA and clopidogrel increased the risk of bleeding by about twofold. However, there is no evidence that the addition of ASA or clopidogrel to dabigatran, or its comparator warfarin, improved outcomes with respect to stroke.

MANAGEMENT: Caution is advised if dabigatran is used in combination with aspirin. Close clinical and laboratory observation for hematologic complications is recommended. Patients should be advised to promptly report any signs of bleeding to their physician, including pain, swelling, headache, dizziness, weakness, prolonged bleeding from cuts, increased menstrual flow, vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or brown urine, or red or black stools.

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MONITOR: Agents that cause urinary alkalinization can reduce serum salicylate concentrations in patients receiving anti-inflammatory dosages of aspirin or other salicylates. The mechanism involves reduction in salicylate renal tubular reabsorption due to increased urinary pH, resulting in increased renal salicylate clearance especially above urine pH of 7. This interaction is sometimes exploited in the treatment of salicylate toxicity.

MANAGEMENT: Patients treated chronically with urinary alkalinizers and large doses of salicylates (i.e. 3 g/day or more) should be monitored for potentially diminished or inadequate analgesic and anti-inflammatory effects, and the salicylate dosage adjusted if necessary.

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ADJUST DOSING INTERVAL: Coadministration with an antacid may reduce the bioavailability of dabigatran following oral administration of dabigatran etexilate. The mechanism of interaction has not been described. In population pharmacokinetic analyses, a reduction in dabigatran exposure by 35% was seen over the first 24 hours following surgery. Thereafter, a reduction of about 11% was observed.

MANAGEMENT: Dabigatran should be administered at least two hours before taking an antacid. Coadministration with dabigatran should be avoided within 24 hours after orthopedic surgery.

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