Dabigatran Capsules 110 mg (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 recurrence of deep vein thrombosis and pulmonary embolism After at least 5 days of parenteral anticoagulant therapy, take this medicine 150mg orally twice daily. (3) For patients who may be at increased risk of bleeding for any of the three indications above (see “3. Patients who should be treated 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 aPTT should be performed to determine whether the risk associated with excessive exposure to this medicine is increased. (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 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 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 For patients who may be at 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) 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 concomitant 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, if hemostasis has not been definitively achieved, initiation of treatment with this medicine should be delayed. If treatment cannot be started on the day of surgery, initiate 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 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. Since this medicine may increase INR, INR testing at least 2 days after discontinuing this medicine more accurately reflects the effect of the vitamin K antagonist; therefore, INR values should be interpreted cautiously 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; this medicine may be administered 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. 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. For patients with moderate renal impairment who are receiving this medicine concomitantly 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 the missed dose as soon as possible on the same day, but no later than 6 hours before the time of your 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 medicine is an anticoagulant that prevents blood coagulation to prevent thrombus formation. It may increase the risk of bleeding, so caution should be exercised in patients with conditions that increase bleeding risk. If bleeding is suspected or blood pressure drops, the healthcare provider should be notified immediately and the bleeding site should be promptly examined. If bleeding is severe, discontinuation of this medicine may be necessary, and immediate treatment should be sought. Patients with multiple risk factors should be closely monitored for signs of bleeding or anemia during treatment. Patients with rapidly deteriorating kidney function should discontinue this medicine. This medicine should not be used in patients who are allergic to it, have severe renal impairment, or are experiencing significant bleeding, or in those who have had recent conditions or surgeries that pose a high risk of bleeding. In addition, the risk of bleeding significantly increases when using this medicine in conjunction with other anticoagulants, so co-administration is generally not recommended. Patients with severe liver impairment or in combination with certain strong drugs should also avoid using this medicine. When used with drugs that affect platelet function, the risk of bleeding may be heightened, so caution is required. Elderly patients, underweight individuals, patients with moderate renal impairment, and those taking certain medications may have increased blood concentrations of this medicine, necessitating careful administration. Bleeding is the most common side effect of this medicine, which can manifest as gastrointestinal bleeding, nasal bleeding, bruising, hematuria, etc. Rarely, severe side effects such as allergic reactions, hepatic dysfunction, thrombocytopenia, myocardial infarction, etc., can occur. After surgery, this medicine should only be resumed after complete hemostasis, and it may need to be temporarily halted in cases of urgent surgery or procedures. In situations with a high risk of bleeding, this medicine should be discontinued and appropriate treatment should be received, and if necessary, medications capable of rapidly reversing its effects may be used. This medicine is not typically monitored through blood coagulation tests, but additional testing may be beneficial in certain situations. It is recommended that women who are pregnant or breastfeeding do not use this medicine, and those planning to become pregnant should avoid its use. The safety and efficacy of this medicine in pediatric patients and individuals under 18 years of age have not been established, thus it is not used in this population. In older adults, the concentration of the drug may increase due to reduced kidney function, so dose adjustments and renal function testing are necessary. Patients with moderate to severe renal impairment may experience significantly increased blood concentrations of this medicine, making renal function testing mandatory before administration and requiring regular monitoring. This medicine is not recommended for patients with severe hepatic impairment. In the event of overdose, the risk of bleeding increases; therefore, immediate notification to healthcare providers is necessary, and appropriate treatment should be administered, which may include consideration of blood dialysis. The capsules of this medicine must not be opened or crushed and should be stored in a cool, dry place out of the reach of children. There are no or very minimal effects on driving or operating machinery. This medicine may interact with other drugs, so patients must discuss concurrent medications with their healthcare provider.

• Bleeding
• reduced hemoglobin
• low blood pressure
• anemia
• thrombocytopenia
• drug hypersensitivity
• rash
• pruritus
• anaphylactic reaction
• angioedema

This medicine should be stored at room temperature between 1 to 30 degrees Celsius and kept in a tightly sealed container to prevent air ingress. It should also be stored in a dry place to maintain its effectiveness.

Appearance

Hard capsule with light blue upper and lower parts filled with a yellowish pellet

Package unit

60 capsules (10 capsules/PTP x 6)