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TARO-RIVAROXABAN is a brand name for Rivaroxaban, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
– Renal Impairment and Geriatrics (>65 years of age)). Safety and efficacy data are available (see 14 CLINICAL TRIALS). 2. , recent cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, patients with spontaneous or acquired impairment of hemostasis • Concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-glycoprotein (P- gp), such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir (see 7 WARNINGS AND– Hematologic) • Concomitant treatment with any other anticoagulant, including Taro-Rivaroxaban (rivaroxaban tablets, Ph.
Eur) Page 5 of 101 Unclassified / Non classifié 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, apixaban, edoxaban, except under circumstances of switching therapy to or from Taro-Rivaroxaban.
2 Breast-feeding) • Hypersensitivity to Taro-Rivaroxaban (rivaroxaban) or to any ingredient in the formulation, (see
2 Breast-feeding) • Hypersensitivity to Taro-Rivaroxaban (rivaroxaban) or to any ingredient in the formulation, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). 4. 1 Dosing Considerations As for any non-vitamin K antagonist oral anticoagulant (NOAC) drug, before initiating Taro-Rivaroxaban (rivaroxaban), ensure that the patient understands and is prepared to accept adherence to NOAC therapy, as directed.
Determine estimated creatinine clearance (eCrCl) in all patients before instituting Taro-Rivaroxaban (rivaroxaban), and monitor renal function during Taro-Rivaroxaban treatment, as clinically appropriate. , acute myocardial infarction (AMI), acute decompensated heart failure (AHF), increased use of diuretics, dehydration, hypovolemia, etc.
Clinically relevant deterioration of renal function may require dosage adjustment or discontinuation of Taro-Rivaroxaban (see below, Renal Impairment). 85 serum creatinine (μmol/L) 72 x serum creatinine (mg/100 mL) Switching from Parenteral Anticoagulants to Taro-Rivaroxaban Taro-Rivaroxaban can be started when the infusion of full-dose intravenous heparin is stopped or 0 to 2 hours before the next scheduled injection of full-dose subcutaneous low-molecular-weight heparin (LMWH) or fondaparinux.
In patients receiving prophylactic heparin, LMWH or fondaparinux, Taro- Rivaroxaban can be started 6 or more hours after the last prophylactic dose. Switching from Taro-Rivaroxaban to Parenteral Anticoagulants Discontinue Taro-Rivaroxaban and give the first dose of parenteral anticoagulant at the time that the next Taro-Rivaroxaban dose was scheduled to be taken.
Taro-Rivaroxaban (rivaroxaban tablets, Ph. Eur) Page 6 of 101 Unclassified / Non classifié Switching from Vitamin K Antagonists (VKA) to Taro-Rivaroxaban To switch from a VKA to Taro-Rivaroxaban, stop the VKA and determine the INR. 5, start Taro-Rivaroxaban at the usual dose.
). Should severe bleeding occur, treatment with TARO-RIVAROXABAN must be discontinued and the source of bleeding investigated promptly. Taro-Rivaroxaban (rivaroxaban tablets, Ph. Eur) Page 15 of 101 Unclassified / Non classifié Close clinical surveillance (looking for signs of bleeding or anemia) is recommended throughout the treatment period, especially in the presence of multiple risk factors for bleeding (see Table 3 below) Table 3 – Factors Which Increase Hemorrhagic Risk Factors increasing rivaroxaban plasma levels Severe renal impairment (CrCl < 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 Vascular retinopathy, such as hypertensive or diabetic 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 drugs affecting hemostasis increases the risk of bleeding.
Care should be taken if patients are treated concomitantly with drugs affecting hemostasis such as non-steroidal anti- inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA), platelet aggregation inhibitors or selective serotonin reuptake inhibitors (SSRI), and serotonin norepinephrine reuptake inhibitors (SNRIs) (see also 9 DRUG INTERACTIONS).
5 mg and ASA should only receive chronic concomitant treatment with NSAIDS, if the benefit outweighs the bleeding risk. The use of Taro-Rivaroxaban is contraindicated in patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rivaroxaban in Canada.
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5 (see Considerations for INR Monitoring of VKA Activity during Concomitant Taro-Rivaroxaban Therapy). Switching from Taro-Rivaroxaban to a VKA As with any short-acting anticoagulant, there is a potential for inadequate anticoagulation when transitioning from Taro-Rivaroxaban to a VKA.
It is important to maintain an adequate level of anticoagulation when transitioning patients from one anticoagulant to another. 0. For the first 2 days of the conversion period, the VKA can be given in the usual starting doses without INR testing (see Considerations for INR Monitoring of VKA Activity during Concomitant Rivaroxaban Therapy).
Thereafter, while on concomitant therapy, the INR should be tested just prior to the next dose of Taro- Rivaroxaban, as appropriate. 0. Once Taro- Rivaroxaban is discontinued, INR testing may be done at least 24 hours after the last dose of Taro- Rivaroxaban and should then reliably reflect the anticoagulant effect of the VKA.
Considerations for INR Monitoring of VKA Activity during Concomitant Taro-Rivaroxaban Therapy In general, after starting VKA therapy, the initial anticoagulant effect is not readily apparent for at least 2 days, while the full therapeutic effect is achieved in 5-7 days.
Consequently, INR monitoring in the first 2 days after starting a VKA is rarely necessary. Likewise, the INR may remain increased for a number of days after stopping VKA therapy. 2 Pharmacodynamics), the INR is not a valid measure to assess the anticoagulant activity of.
The INR is only calibrated and validated for VKA and should not be used for any other anticoagulant, including Taro-Rivaroxaban. When switching patients from Taro-Rivaroxaban to a VKA, the INR should only be used to assess the anticoagulant effect of the VKA, and not that of Taro-Rivaroxaban.
Therefore, while patients are concurrently receiving Taro-Rivaroxaban and VKA therapy, if the INR is to be tested, it should not be before 24 hours after the previous dose of Taro-Rivaroxaban, and should be just prior to the next dose of Taro-Rivaroxaban, since at this time the remaining Taro-Rivaroxaban concentration in the circulation is too low to have a clinically important effect on the INR.
2 Pharmacodynamics). 2 Recommended Dose and Dosage Adjustment Prevention of VTE after THR or TKR The recommended dose is one 10 mg tablet once daily. Taro-Rivaroxaban 10 mg may be taken with or without food. The initial dose should be taken within 6 to 10 hours after surgery, provided that hemostasis has been established.
If hemostasis is not established, treatment should be delayed. The duration of administration depends on the type of surgery: • After elective THR surgery, patients should be administered Taro-Rivaroxaban for 35 days. • After elective TKR surgery, patients should be administered Taro-Rivaroxaban for 14 days.
Treatment of VTE and […]
6-fold on average, which increases bleeding risk. 4 Drug-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 before combining this therapy with Taro-Rivaroxaban.
5 mg BID has not been studied in combination with, or as replacement of dual antiplatelet therapy (DAPT) for the prevention of stroke, myocardial infarction and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease (CAD) with or without peripheral artery disease (PAD).
The combination has also not been studied for the prevention of atherothrombotic events in patients with symptomatic PAD at demonstrated high risk of major adverse limb events (MALE) or major adverse cardiovascular and cerebrovascular events (MACCE).
Taro-Rivaroxaban (rivaroxaban tablets, Ph. 5 mg BID is not indicated in patients with unstable atherosclerotic disease when DAPT is indicated. Concomitant ASA use (almost exclusively at a dose of 100 mg or less) with either rivaroxaban or warfarin during the ROCKET-AF trial was identified as an independent risk factor for major bleeding (see also 9 DRUG INTERACTIONS).
The antiplatelet agents, prasugrel and ticagrelor, have not been studied with rivaroxaban, and are not recommended as concomitant therapy. The use of thrombolytics should generally be avoided during acute myocardial infarction (AMI) or acute stroke in patients treated with rivaroxaban, due to expected increased risk of major bleeding (see