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SANDOZ APIXABAN SDZ is a brand name for Apixaban, supplied as a tablet. 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.
, ritonavir (see WARNINGS AND PRECAUTIONS, Drug Interactions, and DRUG INTERACTIONS, Inhibitors of both CYP 3A4 and P-gp) Concomitant treatment with any other anticoagulant, including o unfractionated heparin (UFH), except at doses used to maintain a patent central venous or arterial catheter, o low molecular weight heparins (LMWH), such as enoxaparin and dalteparin, o heparin derivatives, such as fondaparinux, and o oral anticoagulants, such as warfarin, dabigatran, rivaroxaban, except under circumstances of switching therapy to or from apixaban.
Hypersensitivity to apixaban or to any ingredients of the formulation. For a complete listing of ingredients see DOSAGE FORMS, COMPOSITION AND PACKAGING. WARNINGS AND PRECAUTIONS PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING SANDOZ APIXABAN SDZ, INCREASES THE RISK OF THROMBOTIC EVENTS.
To reduce this risk, consider coverage with another anticoagulant if Sandoz Apixaban SDZ is discontinued for a reason other than pathological bleeding or completion of a course of therapy. The following Warnings and Precautions are listed in alphabetical order.
Bleeding The possibility of a hemorrhage should be considered in evaluating the condition of any anticoagulated patient. As with all anticoagulants, apixaban should be used with caution in circumstances associated with an increased risk of bleeding.
Bleeding can occur at any site during therapy with apixaban. An unexplained fall in hemoglobin, hematocrit or blood pressure should lead to a search for a bleeding site. Patients should be advised of signs and symptoms of blood Sandoz Apixaban SDZ Page 5 of 72 loss and to report them immediately or go to an emergency room.
Patients at high risk of bleeding should not be prescribed Sandoz Apixaban SDZ (see CONTRAINDICATIONS). Should severe bleeding occur, treatment with Sandoz Apixaban SDZ must be discontinued and the source of bleeding investigated promptly.
, looking for signs of bleeding or anemia) is recommended throughout the treatment period. g. , especially if other factors/conditions that generally increase the risk of hemorrhage are also present. (see Table 1 below). Table 1 – Factors Which Increase Hemorrhagic Risk Factors increasing apixaban plasma levels Severe renal impairment (eCrCl < 30 mL/min) Concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp Pharmacodynamic interactions NSAID Platelet aggregation inhibitors, including ASA, clopidogrel, prasugrel, ticagrelor Selective serotonin reuptake inhibitors (SSRI), and serotonin norepinephrine reuptake inhibitors (SNRIs) Diseases / procedures with special hemorrhagic risks Congenital or acquired coagulation disorders Thrombocytopenia or functional platelet defects Uncontrolled severe arterial hypertension Active ulcerative gastrointestinal disease Recent gastrointestinal bleeding Recent intracranial hemorrhage Intraspinal or intracerebral vascular abnormalities Recent brain, spinal or ophthalmological surgery Bronchiectasis or history of pulmonary bleeding Others Age > 75 years Concomitant use of apixaban with drugs affecting hemostasis increases the risk of bleeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Apixaban 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.
Care should be taken if patients are treated concomitantly with drugs affecting hemostasis such as non-steroidal anti-inflammatory drugs (NSAID), acetylsalicylic acid (ASA), platelet aggregation inhibitors, selective serotonin reuptake inhibitors (SSRI), or serotonin norepinephrine reuptake inhibitors (SNRIs) (see also DRUG INTERACTIONS).
Concomitant use of ASA or dual antiplatelet therapy with either apixaban or warfarin increases the risk of major bleeding in patients with atrial fibrillation. Other platelet aggregation inhibitors such as prasugrel and ticagrelor, have not been studied with apixaban in any patient population, and are not recommended as concomitant therapy (see DRUG INTERACTIONS).
In patients with atrial fibrillation and having a condition that warrants single or dual antiplatelet therapy, a careful assessment of the potential benefits against the potential risks should be made Sandoz Apixaban SDZ Page 6 of 72 before combining this therapy with apixaban.
In high-risk patients following acute coronary thrombosis, apixaban 5 mg bid, as an adjunct to standard anti-platelet treatment, has led to significantly increased bleeding (see ACTION AND CLINICAL PHARMACOLOGY, Post-acute coronary syndrome patients).
The use of thrombolytics should generally be avoided during acute myocardial infarction (AMI) or acute stroke in patients treated with apixaban, due to expected increased risk of major bleeding. Cardiovascular Patients with Valvular Disease Safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves or those with hemodynamically significant rheumatic heart disease, especially mitral stenosis.
5 mg twice daily provides adequate anticoagulation in patients with prosthetic heart valves, with or without atrial fibrillation. Therefore, the use of apixaban is not recommended in […]