Boryeong Dabigatran Capsule 110 mg (Dabigatran etexilate)

Adult dose

This medicine should be taken with water, regardless of meals. 1. Adults (1) Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation Administer orally at a dose of 150 mg 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 use, administer this medicine orally at a dose of 150mg twice daily. (3) In patients who may have an increased risk of bleeding for the three indications above (see “3. Patients who should be treated with caution” under Precautions for Use), administration of 110 mg twice daily may be considered. These patients should be carefully monitored clinically for signs of bleeding or anemia, and coagulation tests such as aPTT should be used to determine whether there is an increased risk due to excessive exposure to this medicine. (4) Prevention of venous thromboembolism in patients who have undergone hip or knee replacement surgery ① Patients who have undergone knee replacement surgery Administer orally at a dose of 220mg (2 capsules of 110mg) once daily. Start treatment with 1 capsule of 110mg of this medicine within 1~4 hours after completion of surgery, and then administer 220mg (2 capsules of 110mg) once daily for a total of 10 days. ② Patients who have undergone hip replacement surgery Administer orally at a dose of 220mg (2 capsules of 110mg) once daily. Start treatment with 1 capsule of 110mg of this medicine within 1~4 hours after completion of surgery, and then administer 220mg (2 capsules of 110mg) once daily for a total of 28~35 days. ③ In patients who may have an increased risk of bleeding (see “3. Patients who should be treated with caution” under Precautions for Use), administration of 150 mg (2 capsules of 75mg) twice daily may be considered. Start treatment with 1 capsule of 75mg of this medicine within 1~4 hours after completion of surgery, and then administer 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 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 administered. ⑤ For both types of surgery, initiation of this medicine should be delayed if hemostasis has not been securely achieved. If treatment cannot be started on the day of surgery, start treatment with 2 capsules once daily. 2. Switching medications (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 recurrence of deep vein thrombosis and pulmonary embolism Start administration of the parenteral anticoagulant 12 hours or more after the last dose of this medicine. ② Prevention of venous thromboembolism in patients who have undergone hip or knee replacement surgery Start administration of the parenteral anticoagulant 24 hours or more after the last dose of this medicine. (2) Switching from a parenteral anticoagulant to this medicine In patients currently receiving a parenteral anticoagulant, administer this medicine 0~2 hours before the next scheduled dose of the parenteral anticoagulant, or when continuous administration (e.g., intravenous administration of unfractionated heparin) is discontinued. (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 recurrence of deep vein thrombosis and pulmonary embolism Adjust the time to start administration of the vitamin K antagonist as follows according to creatinine clearance (Creatinine Clearance, CrCl). • CrCl 50 mL/min or greater: Start administration of a vitamin K antagonist 3 days before discontinuing this medicine. • CrCl ≥ 30~<50 mL/min: Start administration of a vitamin K antagonist 2 days before discontinuing this medicine. Since this medicine may increase INR, INR results most accurately reflect the effect of the vitamin K antagonist when measured at least 2 days after discontinuing this medicine; 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 non-valvular 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 less than 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 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. Administration of 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. If a patient with moderate renal impairment is receiving this medicine with verapamil, administration of 75mg once daily may be considered. Administration of 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 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 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 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 who have undergone hip or knee replacement surgery Take the recommended daily dose of this medicine at the same time the next day. Do not take twice the recommended daily dose to make up for a missed dose.

This medication can cause bleeding and should be used cautiously in patients at high risk for bleeding. If serious bleeding occurs, administration should be stopped immediately and the bleeding site should be promptly assessed. Patients with certain diseases or conditions (e.g., renal impairment, recent surgery, gastrointestinal ulcers, etc.) should avoid using this medication. Caution is needed when used in conjunction with other anticoagulants or antiplatelet agents, which may increase the risk of bleeding. This medication may accumulate in patients with renal impairment, so regular renal function tests should be performed. Women who are pregnant or breastfeeding should either not use this medication or consult with a specialist. Elderly patients may have reduced kidney function, so dose adjustments and careful monitoring are necessary. During the course of this medication, signs of bleeding (e.g., nosebleeds, gum bleeding, bruising, hematuria, etc.) should be closely monitored. This medication may need to be temporarily discontinued prior to surgery or invasive procedures, and healthcare providers should be consulted. This medication may interact with certain drugs (e.g., strong P-gp inhibitors and inducers, anticoagulants, antiplatelet agents, etc.), so patients should inform about all other medications taken. Capsules should not be opened or divided arbitrarily, and the method of administration should be followed accurately. In case of overdose, the risk of bleeding may increase, so the prescribed dosage should be adhered to, and if abnormal symptoms occur, immediate consultation with a healthcare institution is required. Routine blood clotting tests (INR) do not accurately reflect the effects of this medication, so standard anticoagulant monitoring is not needed. While this medication does not significantly impact driving or machinery operation, caution should be exercised in case of bleeding symptoms.

• Hemorrhage
• decreased hemoglobin
• decreased blood pressure
• anemia
• thrombocytopenia
• drug hypersensitivity reactions
• rash
• pruritus
• anaphylactic reactions
• angioedema

This medication should be stored at room temperature between 1°C and 30°C, in a tightly closed container that is well-ventilated. Additionally, it should be kept away from humid places to maintain its efficacy.

Appearance

Hard capsule with light blue upper and lower parts filled with light yellow pellets

Package unit

30 capsules (10 capsules/PTP x 3)