Dabigatran Capsule 150 mg (Dabigatran etexilate)

Adult dose

Administer this medicine with water, regardless of meals. 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 use, take 150mg orally twice daily. (3) For patients who may be at increased risk of bleeding with the three indications above (see “3. Patients Requiring 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 assess whether excessive exposure to this medicine has increased the risk. 2. Switching medications (1) Switching from this medicine to a parenteral anticoagulant Start administering a 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 at which the vitamin K antagonist is started according to creatinine clearance (Creatinine Clearance, CrCl), as follows. • CrCl 50 mL/min or higher: Start administering a vitamin K antagonist 3 days before discontinuing this medicine. • CrCl ≥ 30~<50 mL/min: Start administering a vitamin K antagonist 2 days before discontinuing this medicine. Because this medicine may increase the INR, checking the 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 This medicine may be administered immediately after discontinuing the vitamin K antagonist if the INR is below 2.0. 3. Patients with renal impairment 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). 4. 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 miss a dose If you miss a dose, 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 medication is used to prevent or treat the formation of blood clots (thrombus) by preventing excessive blood coagulation. It can cause bleeding; therefore, special caution is necessary for patients at high risk of bleeding. If bleeding is suspected, it is crucial to inform healthcare professionals immediately, and tests may be needed to determine the site of bleeding. In the event of severe bleeding, discontinue this medication and seek prompt treatment. Patients at high risk of bleeding or with multiple risk factors should undergo regular tests to monitor for symptoms of bleeding or anemia during treatment. This medication should not be administered to patients with rapidly deteriorating renal function, and regular kidney function tests are essential. Patients with an allergy to this medication, severe renal disease, significant bleeding, recent gastrointestinal ulcer, brain hemorrhage, or specific vascular diseases should not use this medication. Additionally, combining this medication with other anticoagulants may significantly increase the risk of bleeding, so it is advisable not to co-administer them. During treatment, caution is needed if factors that increase bleeding risk, such as medication that inhibits platelet aggregation, specific heart diseases, gastrointestinal disorders, elderly age, or low body weight, are present. This medication may have various side effects, including bleeding, anemia, skin rash, liver dysfunction, and gastrointestinal disturbances, so it's important to consult healthcare professionals immediately if abnormal symptoms occur. Particularly, when undergoing surgery or invasive procedures, the risk of bleeding may increase, so dosing should be adjusted around the time of surgery, and coagulation tests may need to be performed. This medication may interact with certain drugs, increasing the bleeding risk when taken together, so patients must inform healthcare professionals about any other medications they are taking. It is safest for pregnant or breastfeeding women to avoid using this medication, and if planning a pregnancy, consultation before use is essential. Use in children under 18 years is not recommended because safety and efficacy have not been established. Elderly patients or individuals with reduced renal function may experience elevated levels of this medication; therefore, dose adjustment and monitoring of kidney function are necessary. In case of overdose, the risk of bleeding can be very high, so it is critical to adhere to the prescribed dosage and administration, and to visit a hospital immediately if any bleeding symptoms occur. Do not open or break the capsule; store in a cool, dry place away from direct sunlight.

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

This medication should be stored at room temperature between 1 and 30 degrees Celsius in a tightly sealed container to prevent air exposure. Additionally, it should be kept in a dry place to maintain its effectiveness.

Appearance

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

Package unit

60 capsules (10 capsules/PTP) x 6