RivaXa

RivaXa10 mg

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Medicine overview

Indications of RivaXa 10 mg

RivaXa 10 mg 2.5 mg: For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine. RivaXa 10 mg ... Read moreRivaXa 10 mg 2.5 mg: For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine. RivaXa 10 mg 10-20 mg: To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Deep vein thrombosis (DVT) & pulmonary embolism (PE) and reduction in the risk of recurrence of DVT and of PE For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery

Theropeutic Class

Oral Anti-coagulants

Pharmacology

RivaXa 10 mg is a highly selective direct factor Xa inhibitor.

Absorption

Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation.

Distribution

RivaXa 10 mg does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.

Dosage of RivaXa 10 mg

RivaXa 10 mg 2.5 mg
Dosage:The recommended dose: 2.5 mg twice daily
Notes:Patients should also take a daily dose of 75-100 mg Aspirin or a daily dose of 75-100 mg Aspirin in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine
RivaXa 10 mg 10-20 mg
Dosage:Nonvalvular Atrial Fibrillation: For patients with Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the evening meal
For patients with Creatinin Clearance 15-50 ml/min
Dosage:15 mg orally, once daily with the evening meal
Treatment of DVT & PE
Dosage:15 mg orally twice daily with food for the first 21 days for the initial treatment of acute DVT or PE
Notes:After the initial treatment period, 20 mg orally once daily with food for the remaining treatment
Prevention in the risk of recurrence of DVT and of PE
Dosage:20 mg once daily with food
Prophylaxis of DVT following Hip replacement surgery
Dosage:10 mg once daily for 35 days
Prophylaxis of DVT following knee replacement surgery
Dosage:10 mg once daily for 12 days
Notes:May be taken with or without food

Administration of RivaXa 10 mg

May be taken with or without food.

Interaction of RivaXa 10 mg

Concomitant use with drugs that are combined P-gp and CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, dronedarone) increases in RivaXa 10 mg exposure and pharmacodynamic effects (i.e., factor Xa inhibition and PT prolongation), that’s why should be avoided. Co-administration of RivaXa 10 mg with a combined P-gp and strong CYP3A4 inducer (e.g., rifampicin, phenytoin, carbamazepine) decreases the efficacy of RivaXa 10 mg and also should be avoided. The concomitant use of other drugs like anti-platelet agents, heparin, fibrinolytic therapy, NSAIDs may cause an increased risk of bleeding.

Contraindications

It is contraindicated in patients with known hypersensitivity of RivaXa 10 mg or any of the excipients of the product. It is also contraindicated in patients with active pathological bleeding.

Side Effects of RivaXa 10 mg

The most common side effects of RivaXa 10 mg have increased chance of bleeding, spinal or epidural hematoma and increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.

Pregnancy & Lactation

There are no adequate or well-controlled studies of RivaXa 10 mg in pregnant women, and dosing for pregnant women has not been established.Safety and efficacy of RivaXa 10 mg have not been established in breast-feeding women

Precautions & Warnings

Early discontinuation of RivaXa 10 mg, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. RivaXa 10 mg increases the risk of bleeding that can be fatal in presence of following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease), vascular retinopathy, bronchiectasis, history of pulmonary bleeding. Signs or symptoms of neurological impairment should be monitored in case of neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture as epidural or spinal hematoma can occur. RivaXa 10 mg is not recommended in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.

Overdose Effects of RivaXa 10 mg

Overdose of RivaXa 10 mg may lead to hemorrhage. RivaXa 10 mg systemic exposure is not further increased at single doses >50 mg due to limited absorption. A specific antidote for RivaXa 10 mg is not available. The use of activated charcoal to reduce absorption in case of RivaXa 10 mg overdose may be considered. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.

Storage Conditions

Store in a cool (below 30°C) & dry place protected from light. Keep away from the reach of children.

Drug Classes

Oral Anti-coagulants

Mode Of Action

RivaXa 10 mg is a highly selective direct factor Xa inhibitor. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibits thrombin formation. RivaXa 10 mg does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.

Pregnancy

RivaXa 10 mg is a pregnancy category C drug. There are no adequate or well-controlled studies of RivaXa 10 mg in pregnant women, and dosing for pregnant women has not been established. It is not known if RivaXa 10 mg is excreted in human milk. The safety and efficacy of RivaXa 10 mg has not been established in breastfeeding women.

Frequently Asked Questions

What is RivaXa 10 mg used for?

Rivaroxaban 2.5 mg: For the prevention of atherothrombotic events in adult patients after an Acute Coronary Syndrome (ACS) with elevated cardiac biomarkers (Troponin or CK-MB). It is co-administered with Aspirin alone or with Aspirin plus Clopidogrel orTidopidine. Rivaroxaban ... Read moreRivaroxaban 2.5 mg: For the prevention of atherothrombotic events in adult patients after an Acute Coronary Sy…

What is the dosage of RivaXa 10 mg?

Rivaroxaban 2.5 mg: The recommended dose: 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg Aspirin or a daily dose of 75-100 mg Aspirin in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine. Rivaroxaban 10-20 mg: Nonvalvular Atrial Fibrillation: For patients with Creatinin Clearance >50 mL/min: 20 mg orally, once daily with the eveni…

What are the side effects of RivaXa 10 mg?

The most common side effects of Rivaroxaban have increased chance of bleeding, spinal or epidural hematoma and increased risk of stroke after discontinuation in nonvalvular atrial fibrillation.

Who should not take RivaXa 10 mg?

It is contraindicated in patients with known hypersensitivity of Rivaroxaban or any of the excipients of the product. It is also contraindicated in patients with active pathological bleeding.

What precautions should be taken with RivaXa 10 mg?

Early discontinuation of Rivaroxaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. Rivaroxaban increases the risk of bleeding that can be fatal in presence of following risk factors- bleeding disorders, uncontrolled severe arterial hypertension, gastrointestinal disease (e.g., inflammatory bowel disease, oesophagitis, gastritis and gastroesophagea…

Is RivaXa 10 mg safe during pregnancy and breastfeeding?

There are no adequate or well-controlled studies of Rivaroxaban in pregnant women, and dosing for pregnant women has not been established.Safety and efficacy of Rivaroxaban have not been established in breast-feeding women

Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.