Yuradak Capsule 110mg (Dabigatran Etexilate)

Adult dose

This medicine may 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 Administer 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 use, administer this medicine 150mg orally twice daily. (3) For patients who may be at increased risk of bleeding for the three indications above (see “3. Patients who should use this medicine with caution” 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 excessive exposure to this medicine may increase 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 Administer 220mg (2 capsules of 110mg) orally once daily. Initiate treatment with 1 capsule of 110mg of this medicine within 1~4 hours after completion of surgery, followed by 220mg (2 capsules of 110mg) once daily for a total of 10 days. ② Patients who have undergone hip replacement surgery Administer 220mg (2 capsules of 110mg) orally once daily. Initiate treatment with 1 capsule of 110mg of this medicine within 1~4 hours after completion of surgery, followed by 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 who should use this medicine with caution” under Precautions for Use), administration of 150 mg (2 capsules of 75mg) orally twice daily may be considered. Initiate treatment with 1 capsule of 75mg of this medicine within 1~4 hours after completion of surgery, followed by 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 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 administered. ⑤ For both types of surgery, initiation of this medicine should be delayed if hemostasis has not been adequately achieved. If administration cannot be started on the day of surgery, treatment should be initiated with 2 capsules once daily. 2. Switching therapy (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 at which the vitamin K antagonist is started 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. This medicine may increase the INR. Since an INR measured at least 2 days after discontinuing this medicine better reflects the effect of the vitamin K antagonist, INR values should be interpreted with caution until then. (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 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 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. For patients with moderate renal impairment 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 following day. Do not take twice the recommended daily dose to make up for a missed dose.

This drug is an anticoagulant that prevents blood from excessively clotting, thus preventing thrombus formation. Care must be taken when using this drug, as the risk of bleeding may increase. Especially, if bleeding is suspected, healthcare professionals should be notified immediately, and if serious bleeding occurs, discontinuation of the drug and swift action is necessary. Patients with severely impaired kidney function or certain diseases, as well as those who are allergic to this drug, should not use it. Additionally, if taken together with other anticoagulants or antiplatelet agents, the risk of bleeding may increase, so it is essential to consult with a healthcare provider. Elderly patients, underweight patients, and those with slightly impaired kidney function may have elevated concentrations of this drug, requiring dosage adjustments and careful monitoring. Generally, there is no need to monitor blood coagulation status, but in cases of reduced kidney function or bleeding risks, blood tests can be performed to confirm the status. Pregnant or breastfeeding women should avoid using this drug, and if planning to become pregnant, consulting before administration is recommended. Capsules must not be opened or crushed and should be stored in a cool, dry place away from direct sunlight. During treatment with this drug, if symptoms of bleeding such as skin bruises, nosebleeds, gum bleeding, hematuria, or melena occur, notify healthcare professionals immediately. Before undergoing surgery or invasive procedures, it is imperative to inform healthcare professionals about the use of this medication, and it may be necessary to temporarily stop it. In case of overdose, the risk of bleeding significantly increases, so the dosage must be strictly adhered to, and if bleeding is suspected, seek medical attention immediately.

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

Store this medication at room temperature between 1°C and 30°C, in a tightly sealed container that is not permeable to air. Additionally, avoid storing it in humid areas to preserve the drug's efficacy.

Appearance

A hard capsule with light blue upper and lower parts filled with yellowish pellets.

Package unit

60 capsules (10 capsules/PTP x 6)