Hybitra Capsule 110 mg (Dabigatran etexilate mesilate)

Adult dosage

This medicine should be taken with water, with or without food. 1. Adults (1) Reduction in 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 in the risk of recurrent deep vein thrombosis and pulmonary embolism After at least 5 days of parenteral anticoagulant therapy, take 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 closely monitored clinically for signs of bleeding or anemia, and coagulation tests such as the aPTT test should be used to assess 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. Begin treatment with 1 capsule of 110mg 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. Begin treatment with 1 capsule of 110mg 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 use this medicine with caution” under Precautions for Use), administration of 150 mg (2 capsules of 75mg) orally twice daily may be considered. Begin treatment with 1 capsule of 75mg 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 a total of 28~35 days (for hip replacement surgery). ④ Bioequivalence has not been established between the 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 given. 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, it should be initiated with 2 capsules once daily. 2. Switching between medicines (1) Switching from this medicine to a parenteral anticoagulant ① Reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism Start administration of the parenteral anticoagulant 12 hours after taking 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 after taking 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 in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism Adjust the time for starting 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, INR should be measured at least 2 days after discontinuing this medicine to best reflect 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 in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent 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 in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent 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 who are 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 in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent 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 in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism/reduction in the risk of recurrent 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 an anticoagulant that thins the blood and prevents clot formation. It may increase the risk of bleeding, so it must be used with extreme caution in patients prone to bleeding or in higher-risk states. Care must be taken if there are symptoms of unexplained anemia or low blood pressure, as it may lead to fatal bleeding; the bleeding site must be checked immediately. If serious bleeding occurs, the medication should be discontinued, and the bleeding site must be examined promptly. Patients with multiple bleeding risk factors must be monitored closely for signs of bleeding or anemia throughout the treatment period. Patients with acute renal failure should not receive this medication and must discontinue it. It should not be administered to patients with known allergies to its ingredients, severe renal impairment, or clinically significant bleeding. Patients with recent gastrointestinal ulcers, malignancies, brain or spinal cord injuries, intracranial bleeding, esophageal varices, or vascular abnormalities should avoid this medication due to a high risk of bleeding. Co-administration with other anticoagulants may significantly increase the risk of bleeding, so it should generally not be used together unless in exceptional cases. Caution is needed when administered to patients with severe hepatic impairment or combined with strong specific medications (P-gp inhibitors or inducers). Care must be taken when used with antiplatelet agents or specific medications due to increased bleeding risk. Elderly patients, underweight individuals, patients with moderate renal impairment, and those with gastrointestinal diseases may have elevated blood concentrations of this medication, so it should be used carefully. Bleeding is the most common side effect of this medication and can be serious. If bleeding signs appear, consult a healthcare professional immediately. Before and after surgery or invasive procedures, the timing of discontinuation or resumption of this medication should be decided carefully due to bleeding risks, and anticoagulation effects should be checked if necessary. Use of this medication is not recommended during pregnancy, and if breastfeeding, nursing should be discontinued. It should not be administered to children as safety and effectiveness have not been established. In case of overdose, the risk of bleeding increases, so the dosage must be strictly followed, and if bleeding symptoms arise, the emergency room must be visited immediately. This medication interacts significantly with many other drugs, especially when taken with blood-thinning medications or those affecting specific hepatic metabolism, so it is essential to consult with healthcare professionals.

• Hemorrhage
• decrease in hemoglobin
• drop in blood pressure
• anemia
• thrombocytopenia
• decrease in hematocrit
• drug hypersensitivity
• rash
• pruritus
• anaphylactic reaction

This medication must be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained between 1° and 30° Celsius, and it is essential to avoid storing it in humid areas.

Appearance

A white capsule filled with white pellets and yellow granules.

Package unit

50 capsules (10 capsules/PTP x 5)