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TEVA-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 ...................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING TEVA-DABIGATRAN, INCREASES THE RISK OF THROMBOTIC EVENTS. To reduce this risk, consider coverage with another anticoagulant if TEVA-DABIGATRAN is discontinued for a reason other than pathological bleeding or completion of a course of therapy.
Bleeding As with all anticoagulants, TEVA-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.
Bleeding can occur at any site during therapy with TEVA-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 TEVA-DABIGATRAN (see CONTRAINDICATIONS).
Should severe bleeding occur, treatment with TEVA-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, idarucizumab, may be used (see Surgery/Procedural Interventions, below, and OVERDOSAGE).
, 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 6 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 The measurement of dabigatran-related anticoagulation may be helpful to avoid excessive high exposure to dabigatran in the presence of additional 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 in the prevention of stroke in patients with atrial fibrillation (AF), and are not recommended as concomitant therapy.
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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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 RELY trial, concomitant use of ASA or clopidogrel with Dabigatran approximately doubled the risk of major bleed, irrespective of the dose of Dabigatran 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 TEVA-DABIGATRAN with an antithrombotic is not recommended for prevention of cardiogenic thromboembolic stroke in AF patients.
e. oral ketoconazole is contraindicated (see CONTRAINDICATIONS). TEVA-DABIGATRAN should not be used with dronedarone (see DRUG INTERACTIONS, Drug-Drug Interactions, Table 14).
Thrombolytic agents:
Since there is very limited experience with the use of thrombolytic agents in conjunction with Dabigatran, a careful risk-benefit assessment is required before instituting thrombolytics due to potential increased risk of major bleeding.
Thrombolytic agents for treatment of acute myocardial infarction or acute ischemic stroke in conjunction with Dabigatran may be considered, if thrombin time (TT), ecarin clotting time (ECT), or activated thromboplastin time (aPTT), not exceeding the upper limit of normal (ULN) have been obtained (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Patients with atrial fibrillation and another cardiovascular condition:
In patients with atrial fibrillation and having another cardiovascular condition that warrants single or dual antiplatelet therapy, a careful assessment of the potential risks against potential benefits 7 should be made before combining this therapy with TEVA-DABIGATRAN.
Specifically, co-administration of oral antiplatelet drugs, including ASA, clopidogrel or NSAIDs, or P-gp inhibitors in patients aged ≥75 years increases the risk of major bleeding, including gastrointestinal bleeding, by about 2-fold.
Cardiovascular Acute myocardial infarction (AMI) Discontinuation of TEVA-DABIGATRAN in the setting of AMI should be considered if the MI treatment involves invasive procedures, such as percutaneous coronary revascularization, or coronary artery bypass surgery.
Similar consideration should be given if thrombolytic therapy is to be initiated, because bleeding risk may be expected to increase. Patients with AMI should be treated according to current clinical guidelines for that disorder. In this setting, TEVA- DABIGATRAN may be resumed for the prevention of stroke and systemic embolism upon completion of these revascularization procedures.
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