Boryung Dabigatran Capsule 150 Milligrams (Dabigatran etexilate)

Adult dose

Administer this medicine with water, regardless of meals. Take 150 mg orally twice daily. After at least 5 days of parenteral anticoagulant use, take 150mg orally twice daily. 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. Start administering a parenteral anticoagulant 12 hours after the last dose of 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. 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. Check the INR at least 2 days after discontinuing this medicine. This medicine may be administered immediately after discontinuing the vitamin K antagonist if the INR is below 2.0. 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). Patients aged 75 years or older: Administration of 110 mg twice daily may be considered because the risk of bleeding may be increased. 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 may increase the risk of bleeding; thus, if any bleeding symptoms occur during treatment, it is imperative to notify healthcare professionals immediately. It should not be used in patients with a high risk of specific bleeding or patients with severely impaired renal function. If taken with other medications that affect blood coagulation, the risk of bleeding may increase; therefore, it is essential to discuss concurrent medications with a doctor. This medication is not recommended for patients with severely impaired liver function, and patients with decreased renal function should undergo regular kidney function tests. Women who are pregnant or may become pregnant should avoid this medication, and breastfeeding women are advised to discontinue breastfeeding. Elderly patients may have an increased risk of bleeding due to potential declines in renal function, necessitating dosage adjustments and monitoring of renal function. Before surgery or invasive procedures, this medication should be temporarily discontinued, and it should be resumed only after complete hemostasis is achieved post-surgery. In cases of overdose, the risk of bleeding increases, so immediate medical attention is required for appropriate actions. This medication is provided in capsule form and should not be opened or damaged. It must be stored in a cool, dry place out of reach of children. While taking this medication, signs of bleeding or symptoms of anemia should be closely monitored, and if any unusual symptoms arise, consultation with healthcare professionals should be sought immediately.

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

This medication should be stored at room temperature between 1°C and 30°C. When storing the medication, it should be kept in a container with a tightly sealed lid to prevent air from entering. Additionally, it is important to store it in a dry place away from humidity.

Appearance

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

Package unit

30 capsules (10 capsules/PTP x 3)