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BLOOD AND BLOOD FORMING ORGANS › ANTITHROMBOTIC AGENTS › ANTITHROMBOTIC AGENTS › Direct factor Xa inhibitors
rivaroxaban and acetylsalicylic acid
B01AF51
Forms & Strengths
- Co-packaged combination: Rivaroxaban 2.5 mg and Acetylsalicylic acid (Aspirin) 100 mg tablets
- Co-packaged combination: Rivaroxaban 2.5 mg and Acetylsalicylic acid (Aspirin) 75 mg tablets
Adult Dosing
- Reduction of risk of major cardiovascular events in patients with coronary artery disease (CAD) or peripheral artery disease (PAD): 2.5 mg rivaroxaban twice daily plus 75-100 mg aspirin once daily
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
Indications
- Reduction of the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in patients with coronary artery disease (CAD)
- Reduction of the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and mortality) in patients with peripheral artery disease (PAD), including those after lower extremity revascularization
Mechanism of Action
- Rivaroxaban is a selective, direct inhibitor of Factor Xa, interrupting the intrinsic and extrinsic coagulation pathways and inhibiting thrombin formation
- Acetylsalicylic acid (aspirin) inhibits cyclooxygenase (COX-1 and COX-2) irreversibly, preventing the synthesis of thromboxane A2 and thereby inhibiting platelet aggregation for the lifespan of the platelet
Contraindications
- Active pathological bleeding (such as intracranial hemorrhage or peptic ulcer)
- Severe hypersensitivity to rivaroxaban, acetylsalicylic acid, or any component of the formulation
- History of asthma, rhinitis, or nasal polyps triggered by salicylate or NSAID administration (due to aspirin component)
- Children and teenagers recovering from viral infections due to the risk of Reye's syndrome (due to aspirin component)
Adverse Reactions
- Major and minor bleeding events (epistaxis, gastrointestinal hemorrhage, hematuria)
- Anemia
- Gastrointestinal distress, dyspepsia, nausea, and abdominal pain
- Gastric or duodenal ulcers
- Bruising and ecchymosis
- Hypersensitivity reactions, including rash and pruritus
Drug Interactions
- Concomitant use with other anticoagulants, antiplatelet agents, NSAIDs, SSRIs, or SNRIs significantly increases the risk of bleeding
- Strong dual inhibitors of CYP3A4 and P-glycoprotein (e.g., ritonavir, ketoconazole) increase rivaroxaban exposure and bleeding risk
- Strong dual inducers of CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, St. John's wort) decrease rivaroxaban efficacy
- Aspirin may antagonize the natriuretic effect of loop diuretics and interact with ACE inhibitors/ARBs, increasing the risk of renal impairment
Curated Content: Needs Vetting Before Put to Clinical Use