Dabigatran etexilate

Dabigatran etexilate. Molecular formula: C34H41N7O5CH4O3S Molecular weight: 723.86 (methanesulfonate), 627.75 (free substance)

Anticoagulants and antiplatelet agents There is limited or no experience with the following therapies that may increase the risk of bleeding when used in combination with this product: anticoagulants such as unfractionated heparin (UFH), low molecular weight heparin (LMWH), and heparin derivatives (fondaparinux sodium, desirudin), thrombolytics, vitamin K antagonists, rivaroxaban or other oral anticoagulants (see "Contraindications"), and antiplatelet agents such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, sulfinpyrazone (see "Precautions"). Limited data from the phase III RE-LY study in patients with atrial fibrillation observed that the combined use of other oral or parenteral anticoagulants, whether dabigatran or warfarin, increased the incidence of major bleeding by approximately 2.5 times, mainly in the case of switching from one anticoagulant to another (see "Contraindications" and "Precautions"). UFH can be used at doses required to maintain the patency of central venous or arterial catheters (see "Contraindications"). Data from the Phase III RE-LY study in patients with atrial fibrillation (see Clinical Trials) observed that the combined use of antiplatelet agents ASA or clopidogrel, regardless of dabigatran or warfarin, doubled the incidence of major bleeding (see Precautions). Clopidogrel: In a Phase I study involving healthy young male volunteers, the combination of dabigatran and clopidogrel did not result in a further prolongation of capillary bleeding time compared with clopidogrel monotherapy. In addition, the dabigatran AUCτ,ss and Cmax,ss, coagulation parameters used to assess the effect of dabigatran, or platelet aggregation inhibition, which is used to assess the effect of clopidogrel, remained essentially unchanged when the combination was used compared with monotherapy. When a loading dose of 300 mg or 600 mg clopidogrel was used, dabigatran AUCτ,ss and Cmax,ss increased by 30% to 40% (see Precautions) (see paragraph on ASA below). ASA: A phase II clinical study investigated the effect of the combined use of dabigatran and ASA on the risk of bleeding in patients with atrial fibrillation. In this study, ASA was randomly used in combination. Based on logistic regression analysis, the combined use of 81mg or 325mg ASA and dabigatran 150mg twice daily may increase the risk of bleeding from 12% to 18% and 24%, respectively. (See "Precautions"). NSAIDs: NSAIDs used for short-term analgesia in the perioperative period and co-administered with dabigatran have been shown to be unrelated to an increased risk of bleeding. In the RE-LY study, long-term use of NSAIDs increased the risk of bleeding with dabigatran and warfarin by approximately 50%. Therefore, due to the risk of bleeding, especially when using NSAIDs with an elimination half-life of >12 hours, close observation of signs of bleeding is recommended (see "Precautions"). LMWH: The combined use of LMWH (such as enoxaparin) and dabigatran has not been specifically studied. When switching from enoxaparin 40 mg subcutaneously once daily for 3 days to dabigatran, dabigatran exposure 24 hours after the last dose of enoxaparin was slightly lower than that after dabigatran alone (single dose 220 mg). The anti-FXa/FIIa activity observed after enoxaparin pretreatment with dabigatran was higher than that after dabigatran alone. This may be due to a carryover effect of enoxaparin treatment and is not considered clinically relevant. Enoxaparin pretreatment did not produce significant changes in other dabigatran-related anticoagulation tests.

Dabigatran etexilate capsules: dabigatran etexilate. Panax notoginseng superfine powder: Panax notoginseng.

Dabigatran etexilate capsules: 1. From the limited data collected from patients with atrial fibrillation in the Phase III study RE-LY, it was observed that the combined use of other oral or injectable anticoagulants, whether dabigatran etexilate or warfarin, increased the incidence of major bleeding by approximately 2.5 times. 2. In a Phase I clinical study involving healthy young male volunteers, the combined use of dabigatran etexilate and clopidogrel did not lead to a further prolongation of capillary bleeding time compared with clopidogrel monotherapy. In addition, compared with monotherapy of the two, when used in combination, indicators such as dabigatran AUCt, ss and Cmax, ss, coagulation indicators used to evaluate the effect of dabigatran, or platelet aggregation inhibition, an indicator used to evaluate the effect of clopidogrel, remained basically unchanged. When using 300mg or 600m