Xarelto (Rivaroxaban 20mg) Tablets

Xarelto general information

What is Xarelto used for?

Xarelto tablets 20mg are used to treat and prevent the formation of blood clots (thrombosis) in conditions where an embolism may result and could be life threatening.  Blood clot formation is a normal response to blood vessel damage to stop bleeding.  However, a blood clot (thrombus) can also form in situations where blood flow is disturbed or slows down due to reduced mobility, heart failure or atrial fibrillation (irregular heart beat).  If a clot becomes detached from the vessel it can travel through the circulation and this is a thromboembolism.  Blood clot formation in the veins is called a venous thrombosis or deep vein thrombosis, because they usually occur in the deep veins of the leg or pelvis and can become lodged in the lungs causing a pulmonary embolism.  If a clot form in an artery or in the heart, it can block the blood supply to the heart tissue and cause a myocardial infarction (heart attack); or it can travel to the brain and cause a stroke.  Xarelto tablets 20mg are used to prevent venous thromboembolism (VTE) following hip or knee replacement surgery when there is increased risk of blots clots due to immobility; also to treat and prevent recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE).  Xarelto tablets 20mg are used to prevent stroke and systemic embolism (blood clots in peripheral blood vessels) due to non-valvular atrial fibrillation and other risk factors, such as congestive heart failure, hypertension (high blood pressure), increasing age over 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (mini stroke).  

How does Xarelto work?

Xarelto tablets 20mg contain rivaroxaban, which is a highly selective direct inhibitor of Factor Xa, a clotting factor in the coagulation cascade.  Factor Xa is a serine protease, an enzyme that converts prothrombin to its active form thrombin.  The coagulation cascade involves the interaction of a series of coagulation factors, which are mostly enzymes, resulting in the generation of plug formed by a fibrous protein (fibrin) that combines with a clump of aggregated platelets and becomes a blood clot or thrombus.  This cascade is activated to prevent bleeding under normal conditions, following injury or trauma to a blood vessel.  It can also be activated if blood becomes stagnant and is no longer free flowing such as when muscles are paralysed during surgical anaesthesia or if the heart pumping mechanism fails such as due to atrial fibrillation.  The intrinsic pathway is initiated when collagen is exposed in damaged blood vessel walls and the extrinsic pathway is activated by tissue factor released from blood vessels as a result of trauma to the endothelial cell lining of the blood vessel.  The activation of Factor Xa is the common link in the coagulation cascade.  Factor Xa plays a pivotal role in the coagulation pathway by directly converting prothrombin to thrombin, which leads to the generation of fibrin resulting in clot formation.  The activation of factor Xa causes amplification of coagulation with a burst of thrombin generation.  Therefore, inhibition of Factor Xa is an effective target for preventing thrombosis, by rapidly inhibiting the burst of fibrin generation and thereby preventing formation of a clot from both the intrinsic and extrinsic pathway.  Several of the coagulation factors, are dependent on Vitamin K as a cofactor in their production and include factors VII, IX, X and II; these are the target of other anticoagulants like warfarin, which can take time to become effective and may need dose adjustment.  Rivaroxaban in Xarelto tablets 20mg is fast acting with high bioavailability when taken orally, is not affected by dietary vitamin K and is effective at a fixed dose.

What does Xarelto contain?

Xarelto tablets contain the active ingredient rivaroxaban 20mg, which is used to treat and prevent the formation of blood clots.  They also contain microcrystalline cellulose, croscarmellose sodium, hypromellose, lactose, magnesium stearate, sodium lauryl sulfate, iron oxide red, macrogol 3350, titanium dioxide

Treating thrombosis with Xarelto

Xarelto tablets 20mg contain rivaroxaban, an anticoagulant are used to treat and prevent the formation of blood clots (thrombosis) in conditions where blood flow is disturbed or slows down due to reduced mobility, heart failure and atrial fibrillation (irregular heart beat).  If a clot (thrombus) becomes detached from the vessel it can travel through the circulation and this is a thromboembolism which could be life threatening if it blocks the blood supply to the heart tissue causing a myocardial infarction (heart attack), or the brain causing a stroke.  Blood clot formation in the veins is called a venous thrombosis or deep vein thrombosis, because they usually occur in the deep veins of the leg or pelvis and can become lodged in the lungs causing a pulmonary embolism.  Xarelto tablets 20mg are used to prevent venous thromboembolism (VTE) following hip or knee replacement surgery when there is increased risk of blots clots due to immobility; also to treat and prevent recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE).  Xarelto tablets 20mg are used to prevent stroke and systemic embolism (blood clots in peripheral blood vessels) due to non-valvular atrial fibrillation and other risk factors, such as congestive heart failure, hypertension (high blood pressure), increasing age over 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (mini stroke).  Rivaroxaban in Xarelto tablets 20mg is a highly selective direct inhibitor of Factor Xa, a serine protease clotting factor in the coagulation cascade that plays a pivotal role in the coagulation pathway by directly converting prothrombin to thrombin, which leads to the generation of fibrin, a fibrous protein that traps aggregated platelets resulting in clot formation.  Rivaroxaban in Xarelto tablets 20mg is fast acting with high bioavailability when taken orally, is not affected by dietary vitamin K and is effective at a fixed dose

What are the side effects of Xarelto?

The most commonly reported side effects when taking Xarelto tablets 20mg include dizziness, headache, tiredness, increased bleeding in the urogenital and gastrointestinal tract including gums and eyes, epistaxis (nose bleeds), haematoma (bruising), gastrointestinal upset (abdominal pains, indigestion, nausea, diarrhoea, vomiting, constipation), pain in the arms or legs, fever, peripheral oedema (water retention), pruritus (itchy skin), hypotension (low blood pressure).  When taking any anticoagulant there is an increased risk of bleeding and this should be monitored.     

When should Xarelto not be used?

You should not use Xarelto tablets 20mg if you:

• are allergic to rivaroxaban or any ingredients in Xarelto
• are pregnant or are breastfeeding
• have kidney or liver disease
• liver disease associated with increased blood coagulation
• have any excessive bleeding or a condition that leads to increased bleeding, like gastrointestinal ulceration
• have a malignant tumour at high risk of bleeding
• are taking medicines that interact with Xarelto including ritonavir for HIV, the antifungal ketoconazole), other anticoagulants like heparin or warfarin, inhibitors of platelet aggregation like clopidogrel, heparin or warfarin, inhibitors of platelet aggregation like clopidogrel and NSAIDs like aspirin, the antiinfective rifampicin, the anticonvulsives carbamazepine and phenytoin, the sedative phenobarbital the herbal remedy St. John’s Wort

What medications interact with Xarelto?

Several medications interact with Xarelto tablets 20mg and should either not be taken while you are taking Xarelto or only after discussion and instruction from your doctor:  

• Drugs that increase bleeding when taken with Xarelto:  ritonavir for HIV, the antifungal ketoconazole), other anticoagulants like heparin or warfarin, inhibitors of platelet aggregation like clopidogrel and NSAIDs like aspirin,
• Drugs that affect Xarelto: ritonavir for HIV, the antifungal ketoconazole), other anticoagulants like heparin or warfarin, inhibitors of platelet aggregation like clopidogrel and NSAIDs like aspirin, the antiinfective rifampicin, the anticonvulsives carbamazepine and phenytoin, the sedative phenobarbital the herbal remedy St. John’s Wort for depression

How should Xarelto be taken?

You should take your Xarelto tablets 20mg swallowed whole with a glass of water, with food, or crushed into food if swallowing is difficult.  The dose you take, how often (once or twice daily) and for how long depends on what you are being treated for and your doctor’s recommendation.  You should continue to take your Xarelto tablets 20mg for as long as recommended by your doctor, which may be for several weeks.

How long should you take Xarelto?

You should continue to take your Xarelto tablets 20mg for as long as recommended by your doctor, which may be for several weeks.

Missed dose of Xarelto

If you miss a dose of Xarelto tablets 20mg take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Xarelto be stored?

You should store your Xarelto tablets 20mg below 25°C in a cool dry place.