Dabio Capsule 150 mg (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 medication prevents blood clotting, and there is a risk of bleeding, so caution is needed. It should not be used in patients at high risk of bleeding or in patients with severely impaired renal function. Care should be taken when used with other anticoagulants or medications that affect blood coagulation, as this may increase the risk of bleeding. If symptoms of bleeding occur, it is necessary to notify medical personnel immediately, as fatal bleeding may occur. When undergoing surgery or invasive procedures, medication may be temporarily discontinued to reduce the risk of bleeding. Elderly patients or those with reduced renal function may have increased drug concentration; therefore, dosage adjustment and renal function tests are necessary. It is advisable for pregnant or breastfeeding women to avoid this medication and to avoid pregnancy while taking it. In case of overdose, the risk of bleeding may increase dramatically, so the dosage should be adhered to precisely, and medical personnel should be consulted immediately in case of overdose. This medication is in capsule form; do not open or crush the capsule, and store it in a cool place away from direct sunlight and moisture. During the use of this medication, it is important to visit a hospital immediately for examination if signs of bleeding or symptoms of anemia appear.

• 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 and kept in a sealed container to prevent exposure to air. It is also recommended to place it in a dry area away from moisture.

Appearance

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

Package unit

60 capsules (10 capsules/PTP x 6)