Dabiran Capsule 150mg (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 nonvalvular 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 at 150mg orally twice daily. (3) For patients who may have an increased risk of bleeding with any of the three indications above (see section ‘3. Patients for whom administration requires 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 test should be used to determine whether excessive exposure to this medicine is increasing the risk. 2. Switching therapy (1) Switching from this medicine to a parenteral anticoagulant Start the parenteral anticoagulant 12 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 Adjust the time to start the vitamin K antagonist according to creatinine clearance (Creatinine Clearance, CrCl), as follows. • CrCl 50 mL/min or greater: 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, measuring INR at least 2 days after discontinuing this medicine 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 Discontinue the vitamin K antagonist and administer this medicine immediately when the INR is less than 2.0. 3. Patients with renal impairment No dose adjustment is required 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). 4. Elderly patients aged 75 years or older Administration of 110 mg twice daily may be considered because the risk of bleeding may be increased. 5. If you forget to take this medicine 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.

This drug is an anticoagulant that prevents blood from excessively clotting, thus preventing thrombus formation. However, the risk of bleeding can increase significantly when using this drug, so special care is necessary. If bleeding occurs, it is essential to quickly identify the cause and receive treatment, and in the event of severe bleeding, this drug should be discontinued immediately. The administration of this drug should also be stopped in cases of rapidly deteriorating kidney function. This drug should not be administered to patients who are allergic to it or have severe kidney dysfunction or clinically significant bleeding. Additionally, patients with recently high-risk conditions for bleeding, such as gastrointestinal ulcers, intracranial hemorrhage, brain or spinal cord injuries, or specific vascular abnormalities should not use it. The risk of bleeding further increases if it is used in conjunction with other anticoagulants, so co-administration should be avoided. This drug is also not recommended for patients with severely impaired liver function. Caution is necessary when used in conjunction with platelet aggregation inhibitors or certain medications, as the risk of bleeding may increase. Elderly patients, patients with low body weight, or those with moderate to severe renal impairment may have increased blood concentration of this drug, heightening the risk of bleeding, so it should be used with caution. The timing of administration of this drug should be adjusted considering the risk of bleeding before and after surgery, and in cases requiring emergency surgery, professional reversal agents may be used. It is advisable that pregnant or breastfeeding women do not use this drug, and safety has not been established for pediatric patients. During the course of taking this medication, patients should always be vigilant for symptoms of bleeding, and any abnormal symptoms should be reported to medical professionals immediately. Furthermore, this drug has many interactions with other medications, so it is crucial to inform healthcare providers of all medications being taken, particularly avoiding co-administration with strong P-gp inhibitors or inducers. This drug is in capsule form, and capsules should not be opened or crushed, and should be stored in a cool, dry place away from direct sunlight.

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

This drug should be stored at room temperature between 1 and 30 degrees Celsius. It is important to keep it in a tightly sealed container protected from air and moisture. To maintain its effectiveness, it should be stored away from areas with high humidity.

Appearance

A hard capsule filled with pale yellow pellets with a bright blue upper part and a white lower part.

Package unit

60 capsules (10 capsules/PTP x 6)