Dabigatran Capsule 110mg (Dabigatran etexilate)

Adult dose

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 non-valvular atrial fibrillation Take 150 mg orally twice daily. (2) Treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism After at least 5 days of parenteral anticoagulant therapy, take 150mg orally twice daily. (3) For patients who may be at increased risk of bleeding for the above three indications (see “3. Patients Requiring Caution” under Precautions for Use), administration of 110 mg orally twice daily may be considered. These patients should be closely monitored clinically for signs of bleeding or anemia, and coagulation tests such as aPTT should be performed to assess whether excessive exposure to this medicine is increasing the risk. (4) Prevention of venous thromboembolism in patients who have undergone hip or knee replacement surgery ① Patients who have undergone knee replacement surgery Take 220mg (2 capsules of 110mg) orally once daily. Start 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 who have undergone hip replacement surgery Take 220mg (2 capsules of 110mg) orally once daily. Start 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 For patients who may be at increased risk of bleeding (see “3. Patients Requiring Caution” under Precautions for Use), administration of 150 mg (2 capsules of 75mg) orally twice daily may be considered. Start 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 a total of 28~35 days (for hip replacement surgery). ④ Bioequivalence has not been established between co-administration 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 given. ⑤ For both types of surgery, initiation of this medicine should be delayed if adequate hemostasis has not been achieved. If administration cannot be started on the day of surgery, treatment should be initiated 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 non-valvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent 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 who have undergone 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, this medicine should be administered 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 non-valvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism The timing of initiation of a vitamin K antagonist should be adjusted as follows according to creatinine clearance (Creatinine Clearance, CrCl). • 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 INR, INR values should be interpreted with caution until at least 2 days after discontinuation of this medicine, when INR testing better reflects the effect of the vitamin K antagonist. (4) Switching from a vitamin K antagonist to this medicine ① Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism Discontinue the vitamin K antagonist and administer this medicine as soon as the INR is below 2.0. 3. Patients with renal impairment (1) Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent deep vein thrombosis and pulmonary embolism No dose adjustment is required 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 who have undergone 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 non-valvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent 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 who have undergone 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 non-valvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction of the risk of recurrent 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 who have undergone 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 is an anticoagulant that prevents the blood from clotting too easily and thereby prevents the formation of blood clots. However, taking this medication may increase the risk of bleeding, so you should immediately consult with a healthcare professional if symptoms of bleeding or decreased blood pressure are suspected. This medication should be discontinued if there is a sudden deterioration in kidney function. Patients who are allergic to this medication, those with severe renal impairment, clinically significant bleeding, or those in states of high bleeding risk such as recent gastrointestinal ulcers or intracranial hemorrhage should not use this medication. Additionally, caution should be exercised when using this medication together with other anticoagulants as it may significantly increase the risk of bleeding. During the course of taking this medication, signs of bleeding should be closely monitored, especially in elderly or patients with impaired kidney function, who may require dose adjustments and regular kidney function tests. The risk of bleeding increases during surgery or invasive procedures, thus careful consideration should be given to temporarily discontinuing this medication before and after surgery. Furthermore, this medication can interact with certain drugs, especially P-glycoprotein inhibitors or inducers, which can increase the risk of bleeding or decrease its efficacy, so it is essential to inform the healthcare provider of any concurrent medications. It should be avoided during pregnancy, and breastfeeding is recommended to be discontinued. Do not open or damage the capsules and store in a cool, dry place out of the reach of children. In case of overdose, the risk of bleeding increases, so it should be taken as directed by a physician, and if bleeding symptoms occur, notify healthcare personnel immediately.

• Hemorrhage
• decrease in hemoglobin
• decrease in hematocrit
• hypotension
• anemia
• thrombocytopenia
• drug hypersensitivity
• rash
• pruritus
• anaphylactic reaction

This medication should be stored at room temperature between 1°C and 30°C, and kept in a well-closed container protected from exposure to air. It is also important to avoid storing it in a humid environment.

Appearance

A hard capsule with the upper part in light blue and the lower part in light blue filled with pale yellow pellets

Package unit

60 capsules (10 capsules/PTP) x 6