Roxarel
Generic Name
Rivaroxaban
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| roxarel 15 mg tablet | ৳ 35.00 | ৳ 350.00 |
Description
Overview of the medicine
Roxarel 15 mg Tablet contains Rivaroxaban, an anticoagulant used to prevent and treat various blood clot-related conditions. It works by inhibiting Factor Xa, a key enzyme in the blood clotting cascade, thereby reducing the risk of thrombosis.
Uses & Indications
Dosage
Adults
For DVT/PE treatment: 15 mg twice daily for the first 21 days, followed by 20 mg once daily. For NVAF: 20 mg once daily. For CAD/PAD: 2.5 mg twice daily (in combination with aspirin). Specific doses vary by indication and renal function.
Elderly
No specific dose adjustment is required based on age, but renal function should be assessed. Higher risk of bleeding in elderly.
Renal_impairment
For NVAF with CrCl 15-49 mL/min: 15 mg once daily. Not recommended for CrCl <15 mL/min or in patients on dialysis. For DVT/PE treatment, avoid use if CrCl <30 mL/min.
How to Take
Take orally with food. For 15 mg and 20 mg doses, it is particularly important to take with food to ensure adequate absorption. The tablet can be crushed and mixed with water or apple sauce immediately before administration, followed by food.
Mechanism of Action
Rivaroxaban is a direct, selective inhibitor of Factor Xa. By inhibiting Factor Xa, it prevents the conversion of prothrombin to thrombin, thereby inhibiting thrombus formation.
Pharmacokinetics
Onset
Anticoagulant effect observed within 2-4 hours.
Excretion
Approximately 2/3 of the dose is excreted via the kidneys (1/3 unchanged, 2/3 as inactive metabolites) and 1/3 via the hepatobiliary/fecal route.
Half life
5-9 hours in young adults; 11-13 hours in elderly.
Absorption
Rapidly absorbed, peak concentrations reached 2-4 hours after administration. Bioavailability is high (80-100%) for 10 mg and 15 mg doses taken with food.
Metabolism
Metabolized primarily via CYP3A4/5 and CYP2J2, with minor contribution from CYP-independent pathways.
Side Effects
Contraindications
- Active pathological bleeding (e.g., active ulceration, intracranial hemorrhage).
- Lesions or conditions at significant risk of major bleeding.
- Concomitant treatment with other anticoagulants (e.g., unfractionated heparin, low molecular weight heparins, warfarin), except when switching therapy or receiving concomitant heparin to maintain catheter patency.
- Severe hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy and lactation.
- Hypersensitivity to Rivaroxaban or any component of the tablet.
Drug Interactions
SSRIs/SNRIs
May increase the risk of bleeding.
Other Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding. Concomitant use is generally contraindicated.
Strong CYP3A4 inducers (e.g., Rifampicin, Phenytoin)
Decrease Rivaroxaban exposure, potentially reducing its efficacy. Concomitant use should be avoided.
NSAIDs, Aspirin, Antiplatelet agents (e.g., Clopidogrel)
Increased risk of bleeding. Use with caution, especially in patients at high bleeding risk.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
Significantly increase Rivaroxaban exposure, leading to an increased bleeding risk. Concomitant use is contraindicated.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose of Rivaroxaban can lead to an increased risk of bleeding. Management includes symptomatic treatment and consideration of activated charcoal (if taken recently). Andexanet alfa is a specific reversal agent for Rivaroxaban in cases of life-threatening or uncontrolled bleeding.
Pregnancy & Lactation
Rivaroxaban is contraindicated during pregnancy due to increased risk of bleeding and potential harm to the fetus. It is not recommended during lactation as it is excreted in breast milk and may cause adverse effects in breastfed infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, check packaging for exact expiry.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies globally, including DGDA (Bangladesh)
Patent Status
Generics available in many regions; original compound's patent expired in some areas.
Clinical Trials
Rivaroxaban has been extensively studied in large-scale clinical trials (e.g., ROCKET AF, EINSTEIN DVT/PE, COMPASS) demonstrating its efficacy and safety for approved indications.
Lab Monitoring
- No routine coagulation monitoring (e.g., INR) is required. However, renal function, liver function tests (LFTs), and hemoglobin levels should be monitored periodically.
- For specific situations, anti-Factor Xa activity assays may be used.
Doctor Notes
- Ensure proper patient selection, especially considering renal and hepatic function.
- Educate patients on bleeding risks and management, including signs to watch for and when to seek medical attention.
- Emphasize strict adherence to dosing and administration instructions (especially taking with food for 15mg/20mg doses).
- Counsel patients on potential drug interactions, particularly with strong CYP3A4 inhibitors/inducers and other anticoagulants/antiplatelets.
- Avoid abrupt discontinuation to prevent increased thrombotic risk.
Patient Guidelines
- Take exactly as prescribed by your doctor, with food.
- Do not stop taking Rivaroxaban without consulting your doctor, as this may increase your risk of blood clots.
- Inform your doctor or dentist about taking Rivaroxaban before any surgery or procedure.
- Be aware of signs of bleeding (e.g., unusual bruising, prolonged bleeding from cuts, blood in urine or stool) and report them immediately.
- Carry an anticoagulant alert card.
Missed Dose Advice
For once-daily doses: Take the missed dose immediately if remembered on the same day. Do not take two doses to make up for a missed dose. For twice-daily doses (e.g., 15 mg for DVT/PE treatment): Take immediately if remembered within 12 hours of the usual time. If more than 12 hours have passed, skip the missed dose and continue with the next scheduled dose.
Driving Precautions
Rivaroxaban has minor influence on the ability to drive and use machines. Some patients may experience dizziness or fainting, which could affect driving ability. Patients should know how they react to Rivaroxaban before driving or operating machinery.
Lifestyle Advice
- Avoid activities that may increase your risk of injury or bleeding.
- Be cautious when using sharp objects or participating in sports.
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