Dabigatran Capsules 150mg (Dabigatran etexilate mesilate)

Adult dosage

This medicine 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 per dose 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 therapy, administer 150mg of this medicine orally twice daily. (3) In patients at increased risk of bleeding in the above three indications (see section ‘3. Patients requiring caution’ under Precautions for Use), administration of 110 mg per dose orally 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 assess whether excessive exposure to this medicine has increased risk. 2. Switching between medications (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 a continuous infusion (e.g., intravenous 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 (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. Because this medicine may increase INR, INR values should be interpreted with caution until at least 2 days after discontinuing this medicine, when INR testing more accurately reflects the effect of the vitamin K antagonist. (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 necessary in patients with mild renal impairment (50 ≤ CrCL ≤ 80 mL/min). In patients with moderate renal impairment (30 ≤ CrCL < 50 mL/min), the risk of bleeding may be increased, so administration of 110 mg per dose twice daily may be considered. This medicine is contraindicated in patients with severe renal impairment (CrCL < 30 mL/min). 4. Patients aged 75 years or older The risk of bleeding may be increased, so administration of 110 mg per dose twice daily may be considered. 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 is used to prevent or treat blood clots by preventing blood from coagulating. Since this drug poses a risk of bleeding, it should be used cautiously in cases of conditions or diseases that lead to a higher risk of bleeding. If signs of serious bleeding occur, administration must be stopped immediately and the site of bleeding should be checked promptly. Particularly, if renal function deteriorates sharply, discontinuation of this medication should occur. This medication should not be used in patients with known allergies to it, severe renal impairment, or clinically significant bleeding. Additionally, patients with recent gastrointestinal ulcers, brain or spinal cord injury, specific surgical history, esophageal varices, vascular anomalies, etc., should also not be treated with this medication. Caution is required when combining with other anticoagulants, as the risk of bleeding can significantly increase. When used with drugs that affect platelet function, the risk of bleeding increases; therefore, careful administration is necessary. Elderly patients or those with low body weight, and patients with mild renal impairment or those on certain medications may have increased blood levels, elevating the risk of bleeding. During the use of this medication, close observation for signs of bleeding or symptoms of anemia is crucial. The most common adverse reaction is bleeding, which can be life-threatening in severe cases, hence caution is warranted. After surgery, this medication should only be resumed once complete hemostasis has been achieved, and in states with high bleeding risk, it should only be resumed after consulting healthcare professionals. This medication is difficult to accurately measure with standard coagulation tests; thus, special tests may be necessary to assess blood conditions if required. Women who are pregnant or may become pregnant should ideally avoid using this medication, and breastfeeding mothers should also discontinue breastfeeding while on this medication. Safety and efficacy in pediatric patients under 18 years of age have not been established, hence it is not recommended. Elderly patients may have reduced renal function; thus, dose adjustment and monitoring of renal function are necessary. Patients with impaired renal function should be cautious as blood levels of this medication may increase, and it should not be used in patients with severe renal failure. The safety of this medication has not been thoroughly confirmed for patients with liver dysfunction, hence use is not recommended. In cases of overdose, the risk of bleeding significantly increases; therefore, the medication must be taken exactly as directed by a physician, and if bleeding symptoms appear, the patient should visit a medical facility immediately. This medication must be taken in capsule form; the capsule should not be opened or its contents removed for consumption. This drug can interact with other medications; therefore, it is essential to consult healthcare professionals, especially when using anticoagulants, antiplatelet agents, certain antibiotics, and some cardiac and neurological medications. Prior to surgery or invasive procedures, the physician should be informed of the use of this medication, and it may be temporarily suspended if necessary.

• Hemorrhage
• reduced hemoglobin
• lowered blood pressure
• anemia
• thrombocytopenia
• decreased hematocrit
• drug hypersensitivity
• rash
• pruritus
• anaphylaxis

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature must maintain between 1 to 30 degrees Celsius at room temperature, and it is advisable to avoid storing it in humid areas.

Appearance

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

Package unit

50 capsules (10 capsules/PTP x 5)