Rivarox-20 Dosage/Direction for Use

Stroke prevention in atrial fibrillation (SPAF): SPAF: Recommended usual dose: The recommended dose is 20 mg one tablet once daily, maximum daily dose is 20 mg.
For patients with moderate renal impairment (creatinine clearance (CrC): <50-30 mL/min) the recommended dose is 15 mg once daily.
SPAF: Missed Dose: If a dose is missed the patient should take rivaroxaban immediately and continue with the once daily intake as recommended on the following day. The dose should not be doubled to make up for a missed dose within the same day.
SPAF: Additional information on special populations: Patients with hepatic impairment: Rivaroxaban is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk.
No dose adjustment is necessary in patients with other hepatic diseases.
Limited clinical data in patients with moderate hepatic impairment indicate a significant increase in the pharmacological activity.
No clinical data are available for patients with severe hepatic impairment.
Patients with renal impairment: No dose adjustment is required if Rivaroxaban is administered in patients with mild renal impairment.
For patients with moderate renal impairment the recommended dose is 15 mg once daily.
Limited clinical data for patients with severe renal impairment indicate that rivaroxaban plasma levels are significantly increased in this patient population.
Therefore, rivaroxaban 15 mg must be used with caution in these patients.
Use of rivaroxaban is not recommended in patients with CrC <15 mL/min.
Cardioversion: Rivaroxaban can be initiated or continued in patients who may require cardioversion.
For transesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, rivaroxaban treatment should be started at least 4 hours before cardioversion to ensure adequate anticoagulation.
Patients who Undergo PCI (Percutaneous Coronary Intervention) with Stent Placement: Patients with non-valvular atrial fibrillation who undergo PCI with stent placement should receive reduced dose of 15 mg rivaroxaban once daily (or 10 mg rivaroxaban once daily for patients with moderate renal impairment [CrCl <50-30 mL/min]) in addition to a P2Y12 inhibitor. This treatment regimen is recommended for a maximum of 12 months after PCI with stent placement. Rivaroxaban dosage should be increased to the standard dose for patients with non-valvular atrial fibrillation.
Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) treatment: DVT/PE: Recommended usual dose: The recommended dose for the initial treatment of acute DVT and PE is 15 mg rivaroxaban twice daily (maximum daily dose is 30 mg) for the first three weeks followed by 20 mg rivaroxaban once daily (maximum daily dose is 20 mg) for the continued treatment and the prevention of recurrent DVT and PE.
DVT/PE: Missed Dose: It is essential to adhere to the dosage schedule provided.
If a dose is missed during the 15 mg twice daily treatment phase the patient should take rivaroxaban immediately to ensure intake of 30 mg rivaroxaban per day. In this case two 15 mg tablets may be taken at once. The patient should continue with the regular 15 mg twice daily intake as recommended on the following day.
If a dose is missed during the 20 mg once daily treatment phase the patient should take rivaroxaban immediately to ensure intake of 20 mg per day. The patient should continue with the regular 20 mg once daily intake as recommended on the following day.
Patients with hepatic impairment: Rivaroxaban is contraindicated in patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk.
No dose adjustment is necessary in patients with other hepatic diseases.
Limited clinical data in patients with moderate hepatic impairment indicate a significant increase in the pharmacological activity.
No clinical data are available for patients with severe hepatic impairment.
Patients with renal impairment: No dose adjustment is required if rivaroxaban is administered in patients with mild or moderate renal impairment.
Limited clinical data for patients with severe renal impairment indicate that rivaroxaban plasma levels are significantly increased in this patient population.
Therefore rivaroxaban must be used with caution in these patients.
Use of rivaroxaban is not recommended in patients with CrC: <15 mL/min.
Additional information on special populations (SPAF, DVT and PE Treatment): Converting from Vitamin K Antagonists (VKA) to Rivaroxaban: For SPAF: VKA treatment should be stopped and rivaroxaban therapy should be initiated when the INR is ≤3.0.
For DVT and PE treatment: VKA treatment should be stopped and rivaroxaban therapy should be initiated when the INR is ≤2.5.
When converting patients from VKAs to rivaroxaban, INR values will be falsely elevated after the intake of rivaroxaban. The INR is not valid to measure the anticoagulant activity of rivaroxaban, and therefore should not be used.
Converting from Rivaroxaban to Vitamin K antagonists (VKA): There is a potential for inadequate anticoagulation during the transition from rivaroxaban to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that rivaroxaban can contribute to an elevated INR.
In patients converting from rivaroxaban to VKA, VKA should be given concurrently until the INR is ≥2.0. For the first two days of the conversion period, standard VKA dosing should be used followed by VKA dosing guided by INR testing. While patients are on both rivaroxaban and VKA, the INR should not be tested earlier than 24 hours (after the previous dose but prior to the next dose of rivaroxaban). Once rivaroxaban is discontinued INR testing maybe done reliably 24 hours after the last dose.
Converting from parenteral anti-coagulants to Rivaroxaban: For patients currently receiving a parenteral anticoagulant, start rivaroxaban 0 to 2 hours before the time of the next scheduled administration of the parenteral drug (e.g. LMWH) or at the time of discontinuation of a continuously administered parenteral drug (e.g. intravenous unfractionated heparin).
Converting from Rivaroxaban to parenteral anti-coagulants: Discontinue rivaroxaban and give the first dose of parenteral anticoagulant at the time that the next rivaroxaban dose would be taken.
Children and adolescents (from birth to 16 or 18 years depending on local law): Safety and efficacy have not been established in children and adolescents below 18 years.
Geriatric patients, gender, body weight, ethnic: No dose adjustment is required based on age, gender, body weight and ethnic differences.
Mode of Administration: Oral use, rivaroxaban 20 mg tablets should be taken with food.