Rivarox
Generic Name
Rivaroxaban 20 mg Tablet
Manufacturer
Manufacturer Name
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
rivarox 20 mg tablet | ৳ 45.00 | ৳ 450.00 |
Description
Overview of the medicine
Rivaroxaban is an oral anticoagulant used to prevent and treat blood clots (thrombosis). It belongs to a class of drugs called direct Factor Xa inhibitors.
Uses & Indications
Dosage
Adults
For NVAF: 20 mg once daily with the evening meal. For DVT/PE treatment: Initial 15 mg twice daily for 21 days, followed by 20 mg once daily. For DVT/PE recurrence prevention: 20 mg once daily.
Elderly
No dose adjustment based on age alone, but renal function should be assessed.
Renal_impairment
CrCl 15-50 mL/min: For NVAF, 15 mg once daily with the evening meal. For DVT/PE treatment and recurrence prevention, 20 mg once daily. CrCl < 15 mL/min or on dialysis: Not recommended.
How to Take
Take orally, with food. For 15 mg and 20 mg doses, it is particularly important to take with food to ensure optimal absorption.
Mechanism of Action
Rivaroxaban is a direct, selective inhibitor of Factor Xa. By inhibiting Factor Xa, it prevents the generation of thrombin, thereby inhibiting thrombus formation.
Pharmacokinetics
Onset
Anticoagulant effect observed within a few hours of administration.
Excretion
Approximately two-thirds of the dose is excreted via the kidneys, with one-third excreted unchanged. The remaining one-third is excreted via the fecal/biliary route as inactive metabolites.
Half life
Terminal half-life is 5-9 hours in healthy adults and 11-13 hours in elderly.
Absorption
Rapidly absorbed. Absolute bioavailability is high (80-100%) for 10 mg, 15 mg, and 20 mg doses, when taken with food. Peak plasma concentration achieved in 2-4 hours.
Metabolism
Metabolized in the liver, primarily via CYP3A4, CYP2J2, and CYP-independent hydrolysis.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding)
- Severe hypersensitivity reaction to rivaroxaban
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- Concomitant treatment with other anticoagulant agents (e.g., unfractionated heparin, low molecular weight heparins, warfarin), except when switching therapy or receiving unfractionated heparin to maintain an open central venous or arterial catheter.
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Increased risk of bleeding, avoid concomitant use.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Significantly increase rivaroxaban exposure, contraindicated.
NSAIDs and antiplatelet agents (e.g., aspirin, clopidogrel)
Increased risk of bleeding, use with caution.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
May decrease rivaroxaban exposure, avoid co-administration.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to an increased risk of bleeding. Management includes supportive care, considering activated charcoal if ingestion was recent, and specific reversal agent Andexanet alfa is available for severe, uncontrolled bleeding.
Pregnancy & Lactation
Pregnancy Category C. Rivaroxaban is not recommended during pregnancy or breastfeeding due to potential risk of bleeding and lack of sufficient data.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding)
- Severe hypersensitivity reaction to rivaroxaban
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- Concomitant treatment with other anticoagulant agents (e.g., unfractionated heparin, low molecular weight heparins, warfarin), except when switching therapy or receiving unfractionated heparin to maintain an open central venous or arterial catheter.
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Increased risk of bleeding, avoid concomitant use.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Significantly increase rivaroxaban exposure, contraindicated.
NSAIDs and antiplatelet agents (e.g., aspirin, clopidogrel)
Increased risk of bleeding, use with caution.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
May decrease rivaroxaban exposure, avoid co-administration.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to an increased risk of bleeding. Management includes supportive care, considering activated charcoal if ingestion was recent, and specific reversal agent Andexanet alfa is available for severe, uncontrolled bleeding.
Pregnancy & Lactation
Pregnancy Category C. Rivaroxaban is not recommended during pregnancy or breastfeeding due to potential risk of bleeding and lack of sufficient data.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years (check product specific label)
Availability
Available in pharmacies and hospitals
Approval Status
FDA Approved
Patent Status
Generic available, Original patent expired in some regions
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials (e.g., ROCKET AF, EINSTEIN DVT, EINSTEIN PE, COMPASS, VOYAGER PAD) have demonstrated the efficacy and safety of rivaroxaban in its approved indications.
Lab Monitoring
- No routine coagulation monitoring (e.g., INR) required. Regular assessment of renal function is recommended, especially in elderly and renally impaired patients. Monitor for signs and symptoms of bleeding.
Doctor Notes
- Emphasize strict adherence to dosing regimen and not to stop abruptly.
- Thorough patient education on bleeding symptoms and when to seek medical attention is crucial.
- Careful assessment of renal function is necessary, especially in elderly patients and those with pre-existing renal impairment, for appropriate dose adjustment.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking Rivaroxaban without consulting your doctor, as this may increase your risk of blood clots.
- Report any unusual bleeding or bruising to your doctor immediately.
- Inform all your healthcare providers (including dentists) that you are taking Rivaroxaban.
Missed Dose Advice
If you miss a dose of Rivaroxaban 20 mg (once daily regimen), take it as soon as you remember on the same day. Do not take two doses at once to make up for a missed dose. If you miss a dose of Rivaroxaban 15 mg (twice daily regimen), you may take two 15 mg tablets at once to get the daily total of 30 mg.
Driving Precautions
Rivaroxaban is not known to affect the ability to drive or use machinery. However, if you experience dizziness, avoid driving or operating machinery.
Lifestyle Advice
- Avoid activities with a high risk of injury to prevent bleeding.
- Maintain good oral hygiene to reduce the risk of gum bleeding.
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