OUR PRODUCTS
Each capsule contains 75 mg dabigatran etexylate
Each capsule contains 110 mg dabigatran etexylate.
Each capsule contains 150 mg dabigatran etexylate .
• Hypersensitivity to the active substance or to any of the excipients
• Patients with severe renal insufficiency (CrCL <30 ml/min)
Clinically effective bleeding
• The lesion or condition, if considered a significant risk factor for severe bleeding. This may include current or recent GI ulcers, presence of malignancy at high risk of bleeding, recent trauma to the brain or spine, recent surgery in the brain, spine or eyes, intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, Aneurysms or major aneurysms. Intramedullary or intracerebral vascular malformations
• Concomitant therapy with any other anticoagulants such as unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, apixaban, etc.) except in under certain conditions.
• Hepatic impairment or liver disease is expected to have no effect on survival.
• Concomitant therapy with the following potent P-gp inhibitors: systemic ketoconazole, cyclosporine, itraconazole, dronedarone and the fixed-dose combination glicaprevir/pibrentasvir
• Artificial heart valves that require anticoagulant treatment.
Ketoconazole: Ketoconazole increases dabigatran AUC0-∞ and total Cmax values by 2.38-fold and 2.35-fold, respectively, after a single 400 mg oral dose, and 2.53-fold and 2.49-fold, respectively, after multiple oral doses of 400 mg ketoconazole once daily .
Dronedarone: When dabigatran etexilate and dronedarone were administered concomitantly, dabigatran AUC0- and Cmax values increased approximately 2.4-fold and 2.3-fold, respectively, after multiple doses of 400 mg dronedarone presentation, and approximately 2.1-fold and 1.9-fold. , respectively, after a single dose of 400 mg
Itraconazole and cyclosporine: Based on laboratory results, a similar effect may be expected with ketoconazole.
Glicaprevir/pibrentasvir: Concomitant use of dabigatran etexilate with a fixed-dose combination of glecaprevir/pibrentasvir (P-gp) inhibitors has been shown to increase exposure to dabigatran and may increase the risk of bleeding.
- Prevention of stroke and systemic embolism in adult patients with NVAF with one or more SPF risk factors.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), prevention of recurring DVT, and adult PE (DVT/PE) as indicated:
- Prevention of stroke and systemic embolism in adult patients with one or more risk factors (SPAF): One Dapeclote 150 mg capsule twice daily.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), prevention of recurring DVT, and PE in adults (DVT/PE): One 150mg Dapilot capsule twice daily after treatment with intravenous anticoagulants for at least 5 days.
- It is recommended to reduce the dose in the elderly over 80 years of age or patients receiving verapamil treatment: a daily dose of 110 mg Dapeclote capsules twice daily.
It is recommended to reduce the dose in the elderly (75-80 years), patients with moderate renal insufficiency
(creatinine clearance 30-50 ml/min.) Patients with gastritis, esophagitis, or gastroesophageal reflux disease and other patients with an increased risk of bleeding: The daily dose of Dapeclot 330 mg or 220 mg should be selected based on the individual assessment of the risk of embolism. Thrombotic and haemorrhage risk.
- Primary prevention of venous thromboembolism in orthopedics and patients after elective hip replacement surgery: One 110 mg capsule taken on the day of surgery 1-4 hours after the end of surgery, and one 110 mg capsule twice daily on the day after surgery and continued for 10 days in The first case lasts for 28-35 days in the second case.
It is recommended to reduce the dose in the elderly (75-80 years), patients with moderate renal insufficiency
(creatinine clearance 30-50 ml/min). Patients receiving treatment with verapamil, quinidine or amiodarone: one Dapeclot 75 mg capsule on the day of the surgery and become one 75 mg capsule twice daily on the day after surgery and continue for the same duration in the previous section.
Minor bruising and bleeding, nausea, abdominal or stomach pain, upset stomach, indigestion, heartburn, diarrhea, rash.
DAPECLOT 75 mg capsule..........(416/2020)
DAPECLOT 110 mg capsule..........(417/2020)
DAPECLOT 150 mg capsule..........(418/2020)
A carton box containing one blister with 10 capsules.