• Brand: ZAXABAN®
  • Generic name:RIVAROXABAN
  • Pharmaceutical form:Tab
  • Amount: 30
  • Pharmaceutical group: CARDIOVASCULAR DRUGS
Download brochure RIVAROXABAN

Film coated tablet
Direct inhibitor of factor Xa (activated factor X)           (Martindale & PDR)
Rivaroxaban 10, 15, 20 mg film coated tablets. 

C19H18ClN3O5S = 435.9           (Martindale & PDR)
Mechanism of action:
Rivaroxaban is a highly selective direct factor Xa inhibitor with oral bioavailability. Inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated. 
(www.medicines.org.uk & PDR)


10 mg: Estimated to be 80% to 100% and it is not affected by food.

Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily. At higher doses rivaroxaban displays dissolution limited absorption with decreased bioavailability and decreased absorption rate with increased dose. This is more marked in fasting state than in fed state.


Plasma protein binding is approximately 92% to 95%, The volume of distribution is moderate with Vss being approximately 50 litres.

Biotransformation and elimination

Of the administered rivaroxaban dose, approximately 2/3 undergoes metabolic degradation, with half then being eliminated renally and half eliminated by the faecal route. The final 1/3 undergoes direct renal excretion as unchanged active substance.

 (www.medicines.org.uk & PDR)
- Deep vein thrombosis prophylaxis
- Deep vein thrombosis treatment
- Nonvalvular atrial fibrillation 
- Pulmonary embolism treatment
- Reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism
(Drug Facts)
- Hypersensitivity to the active substance or to any of the excipients.
- Active pathological bleeding
- Lesion or condition, if considered to be a significant risk for major bleeding.
- Concomitant treatment with any other anticoagulants.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk. 
(PDR & www.medicines.org.uk)
Warnings & Precautions:                                                                     
Increased risk of stroke after discontinuation in nonvalvular atrial fibrillation: Discontinuing rivaroxaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. 
Risk of bleeding: Rivaroxaban increases the risk of bleeding and can cause serious or fatal bleeding. In deciding whether to prescribe rivaroxaban to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding. 
 Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid). There is neither scientific rational for benefit nor experience with systemic hemostatics (desmopressin and aprotinin) in individuals receiving rivaroxaban.
Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, and NSAIDs.
Concomitant use of drugs that are combined P-gp and CYP3A4 inhibitors (e.g. ketoconazole and ritonavir) increases rivaroxaban exposure and may increase bleeding risk.
Spinal/Epidural anesthesia or puncture: When neuraxial anesthesia or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complication are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.
An epidural catheter should not be removed earlier than 18 hours after the last administration of rivaroxaban. The next rivaroxaban dose is not to be administered earlier than 6 hours after the removal of the catheter. If traumatic puncture occurs, the administration of rivaroxaban is to be delayed for 24 hours.
Risk of pregnancy related hemorrhage: Rivaroxaban should be used with caution in pregnant women and only if the potential benefit justifies the potential risk to the mother and fetus.
Renal impairment: In patients with severe renal impairment (creatinine clearance < 30 ml/min) rivaroxaban plasma levels may be significantly increased (1.6 fold on average) which may lead to an increased bleeding risk. Rivaroxaban is to be used with caution in patients with creatinine clearance 15-29 ml/min. Use is not recommended in patients with creatinine clearance < 15 ml/min.
In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations rivaroxaban is to be used with caution.
Other haemorrhagic risk factors: rivaroxaban is to be used with caution in patients with an increased bleeding risk such as:
• congenital or acquired bleeding disorders
• uncontrolled severe arterial hypertension
• other gastrointestinal disease 
• vascular retinopathy
• bronchiectasis or history of pulmonary bleeding.
Dosing recommendations before and after invasive procedures and surgical intervention other than elective hip or knee replacement surgery: If an invasive procedure or surgical intervention is required, rivaroxaban 10 mg should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician.
If the procedure cannot be delayed the increased risk of bleeding should be assessed against the urgency of the intervention. Rivaroxaban should be restarted as soon as possible after the invasive procedure.
Elderly population: Increasing age may increase haemorrhagic risk.
Paediatric population: Safety and efficacy have not been established for children and adolescents up to 18 years.
Pregnancy and Breast – feeding: 
FDA Pregnancy Category: C
Rivaroxaban should be used with caution in pregnant and breast-feeding women and only if the potential benefit justifies the potential risk to the mother and fetus/newborn.                            (PDR)
Drug Interactions:
Drugs that inhibit cytochrome P450 3A4 enzymes and drug transport systems (e.g. ketoconazole, ritonavir, clarithromycine, erythromycin, fluconazole); drugs that induce cytochrome P450 3A4 enzymes and drug transport systems (e.g. rifampicin, carbamazepine, phenytoin, rifampin, St. John's wort); anticoagulants (due to increased bleeding risk); NSAIDs/aspirine; clopidogrel; warfarin.                                                                                        (PDR & www.medicines.org.uk)
Adverse Reactions: 
Common: anaemia (incl. respective laboratory parameters), dizziness, headache, eye haemorrhage, hypotension, haematoma, epistaxis, haemoptysis, gingival bleeding, gastrointestinal tract haemorrhage (incl. rectal haemorrhage), gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting, pruritus, rash, ecchymosis, cutaneous and subcutaneous haemorrhage, pain in extremity, urogenital tract haemorrhage (incl. haematuria and menorrhagia), renal impairment (incl. blood creatinine increased, blood urea increased), fever, peripheral oedema, decreased general strength and energy, increase in transaminases, postprocedural haemorrhage (incl. postoperative anaemia, and wound haemorrhage), contusion, wound secretion; Uncommon: thrombocythemia, allergic reaction, dermatitis allergic, cerebral and intracranial haemorrhage, syncope, tachycardia, dry mouth, hepatic function abnormal, urticaria, haemarthrosis, feeling unwell (incl. malaise), increased bilirubin, increased blood alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased GGT; Rare: jaundice, muscle haemorrhage, localised oedema,                                                                                                       (www.medicines.org.uk)
Rare cases of overdose up to 600 mg have been reported without bleeding complications or other adverse reactions. Due to limited absorption a ceiling effect with no further increase in average plasma exposure is expected at supratherapeutic doses of 50 mg rivaroxaban or above.
A specific antidote antagonising the pharmacodynamic effect of rivaroxaban is not available.
The use of activated charcoal to reduce absorption may be considered.
Management of bleeding:
Should a bleeding complication arise in a patient receiving rivaroxaban, the next rivaroxaban administration should be delayed or treatment should be discontinued as appropriate. Rivaroxaban has a halflife of approximately 5 to 13 hours. Management should be individualised according to the severity and location of the haemorrhage.
Appropriate symptomatic treatment could be used as needed, such as mechanical compression (e.g. for severe epistaxis), surgical haemostasis with bleeding control procedures, fluid replacement and haemodynamic support, blood products (packed red cells or fresh frozen plasma, depending on associated anaemia or coagulopathy) or platelets.
If bleeding cannot be controlled by the above measures, administration of a specific procoagulant reversal agent should be considered, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa).
Redosin of recombinant factor VIIa shall be considered. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. There is limited experience with tranexamic acid and no experience with aminocaproic acid and aprotinin. There is neither scientific rationale for benefit nor experience with the use of the systemic haemostatic desmopressin in individuals receiving rivaroxaban. Due to the high plasma protein binding rivaroxaban is not expected to be dialysable. 
- Deep vein thrombosis prophylaxis
Usual dosage: 10 mg once daily. Initial dose should be at least 6 to 10 hours after surgery once hemostasis has been established.
- Deep vein thrombosis treatment
Initial dosage: 15 mg twice daily with food for 21 days.
Maintenance dosage: 20 mg once daily with food.
- Nonvalvular atrial fibrillation: 20 mg once daily with evening meal. 
- Pulmonary embolism treatment
Initial dosage: 15 mg twice daily with food for 21 days.
Maintenance dosage: 20 mg once daily with food
- Reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism 
20 mg once daily with food.                                                                                      (Drug Facts)
Store at 25°C; excursions are permitted between 15° and 30°C.                            (Drug Facts)
How supplied: 
Rivaroxaban 10,15 and 20 mg film coated tablets are manufactured at Tehran Darou pharmaceuticals and are available, blister of 10 in a box of 30׳s.  

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