Dabigatran Capsules 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 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 determine whether the risk has increased 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 Take 220mg (2 capsules of 110mg) orally once daily. Start treatment with 1 capsule of 110mg of this medicine within 1~4 hours after surgery is completed, and thereafter administer 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 treatment with 1 capsule of 110mg of this medicine within 1~4 hours after surgery is completed, and thereafter administer 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 surgery is completed, and thereafter administer 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 administered. ⑤ For both types of surgery, if hemostasis has not been securely achieved, initiation of this medicine should be delayed. If treatment cannot be started on the day of surgery, it should be started 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 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 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, 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 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 better 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 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. 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. When a patient with moderate renal impairment is 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 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 is used to prevent or treat thrombus formation by interfering with normal blood clotting. However, it can increase the risk of bleeding, so it is important to consult a healthcare provider immediately if bleeding is suspected. It should not be used in patients with severely impaired kidney function or those at high risk of bleeding. Care should be taken when using this medication along with other anticoagulants or antiplatelet agents as the risk of bleeding may increase. Regular monitoring of kidney function is necessary during treatment, and signs of bleeding should be constantly observed. Additionally, when undergoing surgery or invasive procedures, this medication should be temporarily discontinued and resumed only after bleeding has been fully controlled post-surgery. It is advised not to use this medication during pregnancy or breastfeeding, and women of childbearing age should avoid becoming pregnant while on this medication. The blood concentration may increase in elderly patients, requiring dose adjustment and kidney function monitoring. Overdose significantly increases the risk of bleeding; therefore, the prescribed dosage and administration should be strictly followed. Capsules should not be opened and should be stored out of reach of children in a cool, dry place away from direct sunlight. There may be drug interactions while taking other medications, so it is essential to inform the healthcare provider about any other medications being taken.

• Hemorrhage
• decrease in hemoglobin
• low blood pressure
• anemia
• thrombocytopenia
• drug hypersensitivity
• rash
• pruritus
• anaphylactic reaction
• angioedema

This medication should be stored at room temperature between 1 and 30 degrees Celsius. It should also be kept in a tightly sealed container that protects it from air and moisture. This ensures the medication's efficacy and safe usage.

Appearance

Hard capsule with light blue upper and lower parts, filled with yellowish pellets

Package unit

60 capsules (10 capsules/PTP x 6)