Dabigatran Capsule 110mg (Dabigatran Exilate Mesilate)

Adult dosage

This medicine should be taken with water, with or without food. 1. Adults (1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Take 150 mg orally twice daily. (2) Treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism After at least 5 days of parenteral anticoagulant therapy, take 150mg orally twice daily. (3) In patients who may be at increased risk of bleeding for the three indications above (see “3. Patients requiring careful administration” under Precautions for Use), administration of 110 mg orally twice daily may be considered. These patients should be carefully monitored clinically for signs of bleeding or anemia, and coagulation tests such as the aPTT should be used to assess whether excessive exposure to this medicine may increase the risk. (4) Prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery ① Patients undergoing knee replacement surgery Take 220mg (2 capsules of 110mg) orally once daily. Start treatment with 1 capsule of 110mg of this medicine within 1~4 hours after completion of surgery, then take 220mg (2 capsules of 110mg) once daily for a total of 10 days. ② Patients undergoing hip replacement surgery Take 220mg (2 capsules of 110mg) orally once daily. Start treatment with 1 capsule of 110mg of this medicine within 1~4 hours after completion of surgery, then take 220mg (2 capsules of 110mg) once daily for a total of 28~35 days. ③ In patients who may be at increased risk of bleeding (see “3. Patients requiring careful administration” under Precautions for Use), administration of 150 mg (2 capsules of 75mg) orally twice daily may be considered. Start treatment with 1 capsule of 75mg of this medicine within 1~4 hours after completion of surgery, then take 150mg (2 capsules of 75mg) once daily for a total of 10 days (for knee replacement surgery) or 28~35 days (for hip replacement surgery). ④ Bioequivalence has not been established between coadministration of 2 capsules of 75mg of this medicine and administration of 1 capsule of 150mg of this medicine; therefore, when administering 150mg of this medicine, 2 capsules of 75mg must be used. ⑤ For both types of surgery, initiation of treatment with this medicine should be delayed if hemostasis has not been securely achieved. If treatment cannot be started on the day of surgery, begin with 2 capsules once daily. 2. Switching between medicines (1) Switching from this medicine to a parenteral anticoagulant ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Start the parenteral anticoagulant 12 hours after the last dose of this medicine. ② Prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery Start the parenteral anticoagulant 24 hours after the last dose of this medicine. (2) Switching from a parenteral anticoagulant to this medicine For patients currently receiving a parenteral anticoagulant, administer this medicine 0~2 hours before the next scheduled dose of the parenteral anticoagulant, or at the time of discontinuation of continuous administration (e.g., intravenous administration of unfractionated heparin). (3) Switching from this medicine to a vitamin K antagonist ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Adjust the time to start the vitamin K antagonist according to creatinine clearance (Creatinine Clearance, CrCl) as follows. • CrCl 50 mL/min or higher: Start the vitamin K antagonist 3 days before discontinuing this medicine. • CrCl ≥ 30~<50 mL/min: Start the vitamin K antagonist 2 days before discontinuing this medicine. Because this medicine may increase the INR, the INR should be tested at least 2 days after discontinuing this medicine, when it more accurately reflects the effect of the vitamin K antagonist. Until then, INR values should be interpreted with caution. (4) Switching from a vitamin K antagonist to this medicine ① Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Discontinue the vitamin K antagonist and administer this medicine immediately when the INR is below 2.0. 3. Patients with renal impairment (1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism No dose adjustment is necessary in patients with mild renal impairment (50 ≤ CrCL ≤ 80 mL/min). In patients with moderate renal impairment (30 ≤ CrCL < 50 mL/min), administration of 110 mg twice daily may be considered because the risk of bleeding may be increased. This medicine is contraindicated in patients with severe renal impairment (CrCL < 30 mL/min). (2) Prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery In patients with moderate renal impairment (30 ≤ CrCL < 50 mL/min), administration of 150mg (2 capsules of 75mg) once daily may be considered because the risk of bleeding may be increased. For patients with moderate renal impairment who are receiving this medicine concomitantly with verapamil, administration of 75mg once daily may be considered. This medicine is contraindicated in patients with severe renal impairment (CrCL < 30 mL/min). 4. Elderly patients aged 75 years or older (1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism Administration of 110 mg twice daily may be considered because the risk of bleeding may be increased. (2) Prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery Administration of 150mg (2 capsules of 75mg) once daily may be considered because the risk of bleeding may be increased. 5. If you forget to take this medicine (1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism / reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism If you forget to take this medicine, take it as soon as possible on the same day, but no later than 6 hours before the next scheduled dose. Do not take twice the recommended daily dose to make up for a missed dose. (2) Prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery Take the recommended daily dose of this medicine at the same time the following day. Do not take twice the recommended daily dose to make up for a missed dose.

This medication prevents blood from clotting normally and helps prevent thrombosis. However, it can increase the risk of bleeding, and if bleeding is suspected, medical staff should be notified immediately. In particular, if serious bleeding occurs, administration of the drug should be discontinued, and the bleeding site should be examined promptly. Patients at high risk for bleeding or with conditions that increase bleeding risk should not use this medication, and patients with severely impaired renal function are also prohibited from receiving it. Elderly patients, underweight patients, and those with slightly impaired renal function should be observed carefully as this medication may elevate their blood concentration. When taken with other drugs that increase bleeding risk, a higher risk of bleeding may occur, so consultation with a doctor is essential. This medication should be temporarily discontinued before surgical or invasive procedures, and it should be resumed only after hemostasis is fully achieved post-surgery. Pregnant or breastfeeding women are advised not to take this medication, and it should also be avoided if pregnancy is planned. Generally, frequent blood coagulation tests are not required with this medication, but additional testing may be necessary in patients with impaired renal function or high bleeding risk. Overdose significantly increases the risk of bleeding, so prescribed doses must be strictly adhered to, and if overdose is suspected, medical staff must be notified immediately. This medication comes in capsule form and should not be opened or have its contents removed to reduce the risk of bleeding. When storing, keep it out of reach of children, away from direct sunlight, and in a cool place with low humidity.

This medication should be stored in an airtight container at room temperature between 1 degree and 30 degrees Celsius. It should be kept in a dry place to maintain its effectiveness, avoiding areas with high humidity.

Appearance

A hard capsule with white upper and lower parts containing white pellets and yellow granules

Package unit

50 capsules (10 capsules/PTP x 5)