Pradaxa 110 mg Capsule (Dabigatran etexilate mesylate)

Adult dosage

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 nonvalvular 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 use, take this medicine orally at a dose of 150mg twice daily. (3) In patients who may be at increased risk of bleeding for the above three indications (see “3. Patients requiring careful administration” under Precautions for Use), oral administration of 110 mg twice daily may be considered. In these patients, carefully monitor clinically for signs of bleeding or anemia, and use coagulation tests such as the aPTT test to assess 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 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, and thereafter 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, and thereafter take 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), oral 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 thereafter 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 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 taken. 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, begin 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 nonvalvular 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 nonvalvular 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 INR, INR values should be interpreted with caution until testing at least 2 days after discontinuing this medicine, when the INR more accurately 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 nonvalvular 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 nonvalvular 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 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 nonvalvular 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 miss a dose of this medicine (1) Reduction of the risk of stroke and systemic embolism in patients with nonvalvular 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 miss a dose of this medicine, take it 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 next day. Do not take twice the recommended daily dose to make up for a missed dose.

This medication is used to thin the blood to prevent or treat blood clots. When using this medication, caution is required as there is a risk of bleeding. Bleeding can occur in any part of the body, and in cases of unexplained drops in blood counts or blood pressure, the bleeding site must be checked. If serious bleeding occurs, discontinue this medication immediately and inspect the bleeding site promptly. This medication should not be used in patients with a high risk of bleeding, certain diseases, or severely impaired kidney function. Care is required when used with antiplatelet agents or certain medications, as the risk of bleeding may increase, and elderly patients or those with low body weight or slightly impaired kidney function should also be used cautiously. This medication is primarily excreted through the kidneys, so decreased kidney function may increase drug concentration and bleeding risk. When undergoing surgery or invasive procedures, the risk of bleeding increases, so this medication should be temporarily discontinued, and coagulation effects should be checked if necessary. Pregnant or breastfeeding women should avoid using this medication, and women planning to become pregnant should avoid it during treatment. Using this medication with other anticoagulants or antiplatelet drugs can greatly increase the risk of bleeding, thus careful monitoring is required when combined. Overdosing on this medication increases the risk of bleeding, so it should be taken in accurate doses as directed by a physician, and if symptoms of bleeding appear, medical personnel should be informed immediately. Capsules must not be opened or crushed, and should be stored in a cool, dry place out of the reach of children.

• Bleeding
• hemoglobin decrease
• hematocrit decrease
• thrombocytopenia
• drug hypersensitivity
• rash
• pruritus
• anaphylactic reaction
• angioedema
• urticaria

This medication should be stored in a sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature, and it is important to avoid storing in humid areas.

Appearance

A hard capsule with white pellets and yellow granules, white on the top and white at the bottom.

Package unit

50 capsules (10 capsules/PTP x 5)