Dabigatran Capsule 150mg (Dabigatran etexilate mesilate)

Adult dosage

This medicine should be taken with water, regardless of meals. 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 recurrent deep vein thrombosis and pulmonary embolism After at least 5 days of parenteral anticoagulant use, administer this medicine 150mg orally twice daily. (3) In patients who may be at increased risk of bleeding for the three indications above (see section ‘3. Patients requiring cautious administration’ under Precautions for Use), administration of 110 mg 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 used to determine whether excessive exposure to this medicine is increasing risk. 2. Switching medicines (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 In patients currently receiving a parenteral anticoagulant, administer this medicine 0~2 hours before the next scheduled dose of the parenteral anticoagulant or at the time of discontinuation of continuous administration (e.g., intravenous administration of unfractionated heparin). (3) Switching from this medicine to a vitamin K antagonist Adjust the time to start the vitamin K antagonist according to creatinine clearance (CrCl) as follows. • CrCl 50 mL/min or more: 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, interpret INR values 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 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. 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 a dose of this medicine is missed If a dose of this medicine is missed, 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 thrombosis by inhibiting excessive blood coagulation. However, it may increase the risk of bleeding; therefore, patients with a heightened risk of bleeding should exercise particular caution. In the event of suspected bleeding, immediate medical attention is required, and examination of the bleeding site is necessary. If major bleeding occurs, discontinue this medication and promptly investigate the bleeding site. This medication should not be used in patients with conditions or diseases that significantly increase bleeding risk, severely impaired renal function, or certain liver diseases. Additionally, concurrent use with other anticoagulants or specific medications may increase the risk of bleeding, thus consultation with medical professionals is necessary. Elderly patients, underweight patients, and those with slightly impaired renal function may require dosage adjustments and careful monitoring as the blood concentration of this medication may be higher. Before and after surgery or invasive procedures, the risk of bleeding increases, so this medication should be temporarily suspended or the timing of re-administration should be adjusted. It is advisable not to use this medication in pregnant or breastfeeding women, and those planning to become pregnant should avoid taking it. Regular monitoring through blood coagulation tests is generally not required, but in certain situations, blood tests may be beneficial. Overdose may significantly increase the risk of bleeding, so strictly adhere to the prescribed dosages and administration methods. During the course of treatment, any bleeding symptoms or adverse reactions should be promptly discussed with healthcare providers. As this medication is in capsule form, do not open the capsule or spill its contents, and store it out of reach of children. Furthermore, it should be stored in a cool place, away from moisture and direct sunlight.

• Hemorrhage
• decreased hemoglobin
• decreased hematocrit
• anemia
• thrombocytopenia
• drug hypersensitivity reaction
• rash
• pruritus
• anaphylaxis-type reaction
• angioedema

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. The appropriate storage temperature is between 1°C and 30°C, and it should be stored away from humid areas.

Appearance

A hard capsule with a white upper part and a white lower part containing white pellets and yellow granules

Package unit

50 capsules (10 capsules/PTP x 5)