Pradaxa Capsule 110 mg (Dabigatran Etexilate Mesilate)

Adult dose

This drug should 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. There is limited experience with administering this drug (110mg or 150mg per dose, twice daily) in combination with a P2Y12 inhibitor (e.g., clopidogrel) after hemostasis has been achieved in patients with nonvalvular atrial fibrillation who underwent percutaneous coronary intervention (PCI) with stent placement. (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 drug orally at 150mg per dose twice daily. (3) For patients at increased risk of bleeding for any of the three indications above, administration of 110 mg orally twice daily may be considered. 2. Switching medications (1) Switching from this drug to a parenteral anticoagulant Start the parenteral anticoagulant 12 hours after the last dose of this drug. (2) Switching from a parenteral anticoagulant to this drug For patients currently receiving a parenteral anticoagulant, administer this drug 0~2 hours before the next scheduled dose of the parenteral anticoagulant, or at the time the continuous administration (e.g., intravenous administration of unfractionated heparin) is discontinued. (3) Switching from this drug to a vitamin K antagonist • CrCl 50 mL/min or higher: Start the vitamin K antagonist 3 days before discontinuing this drug. • CrCl ≥ 30~<50 mL/min: Start the vitamin K antagonist 2 days before discontinuing this drug. (4) Switching from a vitamin K antagonist to this drug Discontinue the vitamin K antagonist and administer this drug immediately when the INR is below 2.0. 3. Patients with renal impairment No dose adjustment is required in patients with mild renal impairment (50 ≤ CrCL ≤ 80 mL/min). For 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 drug is contraindicated in patients with severe renal impairment (CrCL < 30 mL/min). 4. Older adults 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 of this drug 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 blood clots by stopping blood from clotting. However, it may cause bleeding risks, hence caution is necessary when prescribing it to patients with elevated bleeding risks. If there is an unexplained decrease in blood levels or blood pressure, check for bleeding sites. If serious bleeding occurs, discontinue the medication immediately and quickly investigate the bleeding site. The medication should be stopped in patients with an increased bleeding risk or rapidly deteriorating renal function. Patients with specific thrombosis conditions, such as antiphospholipid syndrome, must carefully compare this medication with other treatments before use. It should not be administered to patients allergic to any ingredients or those with severe renal impairment or clinically significant bleeding. Caution is also required when this medication is used in conjunction with other anticoagulants, and it should not be combined with patients having severe liver damage or using certain strong medications. Co-administration with drugs affecting blood coagulation may increase the risk of bleeding, therefore careful monitoring is required. This medication typically does not require frequent monitoring of coagulation status, but patients with decreased renal function or bleeding risks should undergo regular renal function tests. Due to increased bleeding risks before and after surgical or invasive procedures, temporary cessation of this medication and confirmation of adequate hemostasis is important. It is advisable not to use this medication during pregnancy, and breastfeeding should be suspended if using this medication. This medication is not recommended for children under 18 years of age due to established safety and efficacy concerns. Elderly patients may experience elevated drug levels due to decreased renal function, necessitating dosage adjustments and monitoring of renal function. In case of overdose, there is an increased risk of bleeding, and immediate consultation with healthcare professionals is essential. If needed, specific reversal agents can be used to counteract anticoagulation effects. Do not open or damage the capsule; store it in a cool and dry place away from children. If any signs of bleeding or adverse reactions occur during treatment, consult a physician immediately.

• Hemorrhage
• decreased hemoglobin
• lowered blood pressure
• anemia
• thrombocytopenia
• decreased hematocrit
• drug hypersensitivity reaction
• rash
• pruritus
• anaphylactic reaction

This medication should be stored at room temperature between 1 and 30 degrees Celsius in an airtight container with good ventilation. Avoid storing in damp places.

Appearance

A hard capsule with a bright blue upper and lower part containing yellow pellets.

Package unit

60 capsules (10 capsules/PTP x 6)