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APO-DABIGATRAN is a brand name for Dabigatran Etexilate, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................................... 3 CONTRAINDICATIONS................................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
APO-DABIGATRAN is contraindicated in: Patients with severe renal impairment (eCrCl < 30 mL/min). g. e. oral ketoconazole or oral glecaprevir/pibrentasvir (see WARNINGS AND PRECAUTIONS, P-gp inhibitors and DRUG INTERACTIONS) Combination with any other anticoagulant, including o unfractionated heparin (UFH), except at doses used to maintain a patent central venous or arterial catheter, or during catheter ablation for atrial fibrillation, o low molecular weight heparins (LMWH), such as enoxaparin and dalteparin, o heparin derivatives, such as fondaparinux, o anti-thrombin agents, such as bivalirudin, and o oral anticoagulants, such as warfarin, rivaroxaban, apixaban, except under circumstances of switching therapy to or from APO-DABIGATRAN.
Patients with prosthetic heart valve(s) requiring anticoagulation due to valvular status itself (see WARNINGS AND PRECAUTIONS, Patients with Valvular Disease). Patients with a known hypersensitivity to dabigatran or dabigatran etexilate or to any ingredient in the formulation or component of the container.
For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING. Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations, Nursing Women). WARNINGS AND PRECAUTIONS PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING APO-DABIGATRAN, INCREASES THE RISK OF THROMBOTIC EVENTS.
To reduce this risk, consider coverage with another anticoagulant if APO-DABIGATRAN is discontinued for a reason other than pathological bleeding or completion of a course of therapy. Bleeding As with all anticoagulants, APO-DABIGATRAN (dabigatran etexilate) should be used with caution in circumstances associated with an increased risk of bleeding.
The possibility of a haemorrhage should be considered in evaluating the condition of any anticoagulated patient. APO-DABIGATRAN Product Monograph Page 5 of 82 Bleeding can occur at any site during therapy with APO-DABIGATRAN. An unexplained fall in hemoglobin and/or hematocrit or blood pressure should lead to a search for a bleeding site.
Patients with a known high risk of bleeding should not be prescribed APO-DABIGATRAN (see CONTRAINDICATIONS). Should severe bleeding occur, treatment with APO-DABIGATRAN must be discontinued and the source of bleeding investigated promptly.
For situations of life-threatening or uncontrolled bleeding, when rapid reversal of the anticoagulation effects of dabigatran is required, the specific reversal agent, PRAXBIND (idarucizumab), may be used (see Surgery/Procedural Interventions, below, and OVERDOSAGE).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dabigatran Etexilate in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
, looking for signs of bleeding or anaemia, by testing for occult blood in the stool or ruling out a significant drop in serum hemoglobin, especially if risk factors which increase bleeding risk are combined (see Table 1 below and DRUG INTERACTIONS, Drug-Drug Interactions, Table 14).
Table 1:
Factors which increase haemorrhagic risk, as identified in clinical studies Factors increasing dabigatran plasma levels Moderate renal impairment (30 - 50 mL/min eCrCl) Co-medication with P-glycoprotein inhibitors, including dronedarone, amiodarone, quinidine and verapamil Pharmacodynamic interactions NSAID (diclofenac) Anti-platelet agents, including ASA, clopidogrel, prasugrel and ticagrelor Selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs) Thrombolytic agents Diseases / procedures with special haemorrhagic risks Congenital or acquired coagulation disorders Thrombocytopenia or functional platelet defects Active ulcerative gastrointestinal disease Recent gastro-intestinal bleeding Recent biopsy or major trauma Recent intracranial haemorrhage Brain, spinal or ophthalmic surgery Bacterial endocarditis Others Age ≥ 75 years APO-DABIGATRAN Product Monograph Page 6 of 82 The measurement of dabigatran-related anticoagulation may be helpful to avoid excessive high exposure to dabigatran in the presence of additiosnal risk factors (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Antiplatelet agents:
Prasugrel and ticagrelor: The ADP receptor inhibitors prasugrel and ticagrelor have not been studied with dabigatran etexilate in the prevention of stroke in patients with atrial fibrillation (AF), and are not recommended as concomitant therapy.
Note that the concomitant use of ticagrelor increases exposure to dabigatran (see DRUG INTERACTIONS, Table 14, Ticagrelor).
NSAIDs, ASA or clopidogrel:
Concomitant use of ASA or other antiplatelet agents, such as clopidogrel, based on medical need to prevent myocardial infarction, should be undertaken with caution. Close clinical surveillance is recommended. In AF patients in the RE-LY trial, concomitant use of ASA or clopidogrel with dabigatran etexilate approximately doubled the risk of major bleed, irrespective of the dose of dabigatran etexilate used.
However, there was little improvement in stroke and systemic embolic events. A similar increase in the risk of major bleed was noted with concomitant use with the study comparator, warfarin. Concomitant use of dabigatran etexilate with an antithrombotic is not recommended for prevention of cardiogenic thromboembolic stroke in AF patients.
e. oral ketoconazole or oral glecaprevir/pibrentasvir is contraindicated (see CONTRAINDICATIONS). APO-DABIGATRAN should not be used with dronedarone (see DRUG INTERACTIONS, Drug-Drug […]