Rivanex
Generic Name
Rivaroxaban
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rivanex 25 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Rivaroxaban is an oral anticoagulant that selectively inhibits Factor Xa. It is used to prevent and treat blood clots in various conditions. The 25 mg strength is an atypical dose and would typically be used under specific medical supervision for high-risk or off-label indications.
Uses & Indications
Dosage
Adults
The 25 mg strength is not a standard approved dose for Rivaroxaban. If prescribed for specific, high-risk or investigational indications, dosage should be strictly determined and monitored by a specialist. Standard Rivaroxaban doses range from 2.5 mg to 20 mg daily, depending on the indication.
Elderly
No general dose adjustment is required based on age, but renal function should be assessed, as older patients are more likely to have renal impairment.
Renal_impairment
For creatinine clearance 15-50 mL/min, dose reduction may be necessary for certain indications. Not recommended for creatinine clearance <15 mL/min due to limited data.
How to Take
Oral administration. For 15 mg and 20 mg doses, take with food. For 2.5 mg and 10 mg doses, can be taken with or without food. Swallow the tablet whole with water.
Mechanism of Action
Rivaroxaban is a highly selective direct Factor Xa inhibitor. By inhibiting Factor Xa, it prevents the generation of thrombin, which is a key enzyme in the coagulation cascade responsible for fibrin formation and clot stabilization. This ultimately reduces the risk of thrombus formation.
Pharmacokinetics
Onset
Anticoagulant effect observed within 2-4 hours.
Excretion
Approximately two-thirds is excreted renally (one-third as unchanged drug, two-thirds as inactive metabolites), and one-third is excreted via the fecal/biliary route.
Half life
5-9 hours in young adults, 11-13 hours in elderly patients.
Absorption
Rapidly absorbed, with peak concentrations reached 2-4 hours post-dose. Oral bioavailability is high (66-80%) for 10 mg and higher doses when taken with food.
Metabolism
Metabolized primarily in the liver by CYP3A4, CYP2J2, and CYP-independent pathways. Approximately 50% is metabolized to inactive metabolites.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Known hypersensitivity to rivaroxaban or any excipients.
- Severe hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Concomitant treatment with other anticoagulants (e.g., unfractionated heparin, low molecular weight heparins, warfarin), except when switching therapy or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter.
Drug Interactions
NSAIDs, aspirin, antiplatelet agents (e.g., clopidogrel, prasugrel)
Increased risk of bleeding, especially gastrointestinal bleeding. Use with caution and monitor for signs of bleeding.
Other anticoagulants (e.g., warfarin, heparin, dabigatran, apixaban)
Increased risk of bleeding. Concomitant use is contraindicated, except during therapy transition.
Strong CYP3A4 and P-gp inhibitors (e.g., ketoconazole, ritonavir, clarithromycin)
May increase rivaroxaban exposure, leading to an increased bleeding risk. Concomitant use is generally not recommended.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
May decrease rivaroxaban exposure, potentially reducing its efficacy.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Rivaroxaban. In case of overdose, supportive care and symptomatic treatment should be initiated. Activated charcoal may be considered if taken recently. For life-threatening bleeding, administration of prothrombin complex concentrate (PCC) or recombinant Factor VIIa may be considered.
Pregnancy & Lactation
Not recommended during pregnancy (Pregnancy Category C) due to potential for maternal bleeding and fetal harm. Avoid during lactation as it is unknown if Rivaroxaban is excreted in human milk.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Known hypersensitivity to rivaroxaban or any excipients.
- Severe hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Concomitant treatment with other anticoagulants (e.g., unfractionated heparin, low molecular weight heparins, warfarin), except when switching therapy or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter.
Drug Interactions
NSAIDs, aspirin, antiplatelet agents (e.g., clopidogrel, prasugrel)
Increased risk of bleeding, especially gastrointestinal bleeding. Use with caution and monitor for signs of bleeding.
Other anticoagulants (e.g., warfarin, heparin, dabigatran, apixaban)
Increased risk of bleeding. Concomitant use is contraindicated, except during therapy transition.
Strong CYP3A4 and P-gp inhibitors (e.g., ketoconazole, ritonavir, clarithromycin)
May increase rivaroxaban exposure, leading to an increased bleeding risk. Concomitant use is generally not recommended.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
May decrease rivaroxaban exposure, potentially reducing its efficacy.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Rivaroxaban. In case of overdose, supportive care and symptomatic treatment should be initiated. Activated charcoal may be considered if taken recently. For life-threatening bleeding, administration of prothrombin complex concentrate (PCC) or recombinant Factor VIIa may be considered.
Pregnancy & Lactation
Not recommended during pregnancy (Pregnancy Category C) due to potential for maternal bleeding and fetal harm. Avoid during lactation as it is unknown if Rivaroxaban is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, EMA, DGDA for various strengths)
Patent Status
Patent protection varies by country; generics available in many markets for standard strengths
Clinical Trials
Rivaroxaban has been extensively studied in large-scale phase III clinical trials such as ROCKET AF (atrial fibrillation), EINSTEIN (VTE treatment and prevention), and ATLAS ACS 2-TIMI 51 (acute coronary syndromes). The 25 mg dose would likely be subject to specific clinical investigation.
Lab Monitoring
- Routine coagulation monitoring (e.g., PT, aPTT) is generally not required, as these tests do not reliably reflect Rivaroxaban's anticoagulant effect.
- Baseline and periodic assessment of renal function (creatinine clearance).
- Baseline and periodic assessment of hemoglobin/hematocrit due to bleeding risk.
- Liver function tests (ALT, AST) periodically, especially in patients with hepatic impairment.
Doctor Notes
- Thoroughly assess patient's bleeding risk before initiating Rivaroxaban and continuously monitor during treatment.
- Evaluate renal function (CrCl) at baseline and periodically, adjusting dose as needed for renal impairment.
- Counsel patients on the importance of adherence and prompt reporting of any bleeding events.
- Be aware of potential drug interactions, especially with strong CYP3A4 inhibitors/inducers and other anticoagulants/antiplatelets.
Patient Guidelines
- Take Rivaroxaban exactly as prescribed by your doctor.
- Do not stop taking Rivaroxaban without consulting your doctor, as this can increase your risk of blood clots.
- Immediately report any signs of unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, blood in urine/stools, heavy menstrual bleeding).
- Inform all healthcare providers (including dentists) that you are taking Rivaroxaban before any medical procedure or surgery.
- If you forget a dose, take it as soon as you remember on the same day. Do not take a double dose to make up for a missed one.
Missed Dose Advice
If you miss a dose, take it as soon as you remember on the same day. Do not take two doses at the same time to make up for a missed dose. Continue with your next scheduled dose.
Driving Precautions
Rivaroxaban is not expected to affect the ability to drive or operate machinery. However, if you experience side effects like dizziness or visual disturbances, avoid driving or operating machinery until you feel well.
Lifestyle Advice
- Avoid activities that carry a high risk of injury, falls, or significant cuts, as these can lead to increased bleeding.
- Maintain a healthy diet and lifestyle, and avoid excessive alcohol consumption.
- If you are concerned about your diet or lifestyle, consult your doctor or a dietician.
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