Verivas
Generic Name
Rivaroxaban
Manufacturer
ACI Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| verivas 10 mg tablet | ৳ 70.00 | ৳ 700.00 |
Description
Overview of the medicine
Verivas 10 mg Tablet contains Rivaroxaban, an oral anticoagulant used to prevent and treat various thromboembolic conditions, such as deep vein thrombosis (DVT) and pulmonary embolism (PE), and to prevent stroke in patients with non-valvular atrial fibrillation.
Uses & Indications
Dosage
Adults
For prophylaxis of DVT after hip or knee replacement surgery: 10 mg orally once daily for 10-14 days (knee) or 35 days (hip). For continued treatment of DVT/PE (after 6 months of initial treatment): 10 mg orally once daily. Always follow physician's instructions.
Elderly
No specific dose adjustment is required based on age alone, but caution should be exercised due to increased risk of bleeding. Renal function should be monitored.
Renal_impairment
For CrCl 15-50 mL/min, dose adjustment may be necessary depending on the indication (e.g., for DVT/PE treatment, consider 15 mg once daily, for DVT prophylaxis 10 mg once daily may be appropriate). Use with caution or avoid if CrCl <15 mL/min.
How to Take
Take orally, with or without food. For doses of 15 mg and 20 mg, take with food. It is recommended to take the tablet at the same time each day.
Mechanism of Action
Rivaroxaban is a highly selective direct Factor Xa inhibitor. By inhibiting Factor Xa, it prevents the formation of thrombin, which is crucial for clot formation, thus reducing the risk of thrombosis.
Pharmacokinetics
Onset
Anticoagulant effect observed within 1-4 hours.
Excretion
Approximately 2/3 of the dose is eliminated via the kidneys (1/3 as unchanged drug, 2/3 as inactive metabolites), and 1/3 via the fecal/biliary route.
Half life
5-9 hours in healthy adults; 11-13 hours in elderly.
Absorption
Rapidly absorbed, with peak concentrations reached 2-4 hours after administration. Oral bioavailability is high (80-100%) for 2.5 mg and 10 mg doses, decreasing at higher doses.
Metabolism
Primarily metabolized in the liver via CYP3A4 and CYP2J2 pathways, with some direct renal excretion.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Hypersensitivity to rivaroxaban or any component of the tablet.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Concomitant treatment with other anticoagulants (e.g., unfractionated heparin, LMWH, fondaparinux, warfarin) except under specific circumstances of switching anticoagulant therapy.
Drug Interactions
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
Decrease rivaroxaban exposure, potentially reducing its efficacy. Concomitant use should be avoided.
Strong CYP3A4 inhibitors/P-gp inhibitors (e.g., ketoconazole, ritonavir)
Significantly increase rivaroxaban exposure, increasing bleeding risk. Concomitant use should be avoided.
Other anticoagulants/antiplatelet agents (e.g., aspirin, NSAIDs, clopidogrel, warfarin, heparin)
Increase the risk of bleeding. Use with caution and monitor closely.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose can lead to an increased risk of bleeding. Management includes activated charcoal to reduce absorption, and supportive care. Specific reversal agent (Andexanet alfa) is available.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for bleeding and harm to the fetus. Women of childbearing potential should avoid pregnancy during treatment. Breastfeeding is not recommended as rivaroxaban is excreted in breast milk.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Hypersensitivity to rivaroxaban or any component of the tablet.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Concomitant treatment with other anticoagulants (e.g., unfractionated heparin, LMWH, fondaparinux, warfarin) except under specific circumstances of switching anticoagulant therapy.
Drug Interactions
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
Decrease rivaroxaban exposure, potentially reducing its efficacy. Concomitant use should be avoided.
Strong CYP3A4 inhibitors/P-gp inhibitors (e.g., ketoconazole, ritonavir)
Significantly increase rivaroxaban exposure, increasing bleeding risk. Concomitant use should be avoided.
Other anticoagulants/antiplatelet agents (e.g., aspirin, NSAIDs, clopidogrel, warfarin, heparin)
Increase the risk of bleeding. Use with caution and monitor closely.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose can lead to an increased risk of bleeding. Management includes activated charcoal to reduce absorption, and supportive care. Specific reversal agent (Andexanet alfa) is available.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for bleeding and harm to the fetus. Women of childbearing potential should avoid pregnancy during treatment. Breastfeeding is not recommended as rivaroxaban is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture
Availability
Pharmacies, hospitals, clinics
Approval Status
FDA Approved, DGDA Registered
Patent Status
Off-patent (generic versions available)
Clinical Trials
Rivaroxaban has been extensively studied in large-scale clinical trials (e.g., ROCKET AF, EINSTEIN-DVT, EINSTEIN-PE, ATLAS ACS 2-TIMI 51) demonstrating its efficacy and safety in various indications.
Lab Monitoring
- Routine coagulation monitoring (e.g., PT, aPTT) is not generally required, but complete blood count (CBC) and renal function (creatinine clearance) should be monitored periodically. Liver function tests may also be considered.
Doctor Notes
- Emphasize strict adherence to dosing regimen to minimize thrombotic and bleeding risks.
- Counsel patients on signs and symptoms of bleeding and when to seek immediate medical attention.
- Review concomitant medications, especially those affecting hemostasis, before initiating rivaroxaban.
Patient Guidelines
- Take Verivas exactly as prescribed by your doctor.
- Do not stop taking Verivas without talking to your doctor, as this may increase your risk of blood clots.
- Inform your doctor or dentist about all medicines you are taking, including over-the-counter drugs, herbal supplements, and vitamins, before any surgery or procedure.
Missed Dose Advice
If you miss a dose of Verivas 10 mg, take it as soon as you remember on the same day. Do not take two doses to make up for a missed dose. Continue your regular dosing schedule the next day.
Driving Precautions
Rivaroxaban is not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or other side effects, you should avoid these activities.
Lifestyle Advice
- Avoid activities that may lead to injury and bleeding (e.g., contact sports).
- Report any signs of unusual bleeding or bruising to your doctor immediately.
- Limit alcohol consumption.
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