Dabigatran etexilate capsules (Pradaxa) Chinese instructions

1. Indications:

Dabigatran etexilate capsules are suitable for the following diseases or conditions:

Stroke prevention in non-valvular atrial fibrillation: Indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Treatment of deep vein thrombosis and pulmonary embolism: Used to treat deep vein thrombosis and pulmonary embolism to help prevent further spread and formation of blood clots.

Post-operative anticoagulation: In some high-risk patients requiring surgery, dabigatran etexilate capsules can be used to prevent postoperative thrombosis.

2. Mechanism of action:

The main ingredient of dabigatran etexilate capsule is dabigatran etexilate, which is a direct thrombin inhibitor. Its mechanism of action includes:

Directly inhibits thrombin activity: Dabigatran etexilate directly binds to thrombin and blocks the activity of thrombin, thereby inhibiting the formation of fibrin and preventing the generation of thrombus.

3. Pharmacology:

Absorption and distribution: Dabigatran etexilate is rapidly absorbed after oral administration, and food has little effect on its absorption. It is widely distributed in the body and has a high degree of binding to blood proteins.

Metabolism and excretion: Dabigatran etexilate is primarily metabolized by the liver and excreted in the urine. Dosage adjustments may be required in patients with impaired renal function.

4. Dosage and usage:

Stroke prevention in non-valvular atrial fibrillation: Twice-daily oral administration is generally recommended, with dosage based on the patient's renal function and other factors.

Treatment of deep vein thrombosis and pulmonary embolism: Dosage and duration of treatment need to be determined on a case-by-case basis.

Anticoagulation after surgery: The medication regimen before and after surgery is determined based on the patient’s bleeding risk and type of surgery.

5. Side effects:

Possible side effects of dabigatran etexilate capsules include:

Bleeding: including gastrointestinal bleeding, urinary tract bleeding, etc.

Gastrointestinal discomfort: such as nausea, diarrhea, etc.

Abnormal liver function: may cause elevated transaminases.

6. Warnings and Precautions:

Bleeding risk: Patients need to be closely monitored for bleeding during medication, especially elderly patients and patients with bleeding risks.

Kidney function monitoring: Patients need to regularly monitor kidney function during medication to ensure the safety and effectiveness of medication.

7. Contraindications:

Dabigatran etexilate capsules are contraindicated under the following circumstances:

Active severe bleeding: Such as ulcers, intracranial hemorrhage, etc.

Allergy to dabigatran etexilate or other drug ingredients: Patients with allergic symptoms should not use this product.

8. Drug interactions:

Antibiotics and antifungals: May increase the risk of bleeding.

Anticoagulant and antiplatelet drugs: Need to be used with caution as they may increase the risk of bleeding.

9. Drugs for special groups:

Pregnant and lactating women: Risks and benefits need to be weighed when used clinically.

Elderly patients: Due to the higher risk of bleeding in elderly patients, caution is required when taking medication.

10. Launch and price status:

Dabigatran etexilate capsules have been launched in China and have been included in medical insurance. Patients can purchase them domestically. Please consult the local hospital pharmacy for specific prices. The main foreign drug is the original drug of dabigatran etexilate capsules. The cheaper one is the Turkish version of the German original drug. The specification is 110mg*60 and the price is about three to four hundred. It is consistent with the ingredients and efficacy of the original drug on the domestic market.