Rivanex
Generic Name
Rivaroxaban
Manufacturer
Generic Pharmaceutical Company
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
rivanex 10 mg tablet | ৳ 25.00 | ৳ 250.00 |
Description
Overview of the medicine
Rivaroxaban is an anticoagulant medication used to prevent and treat blood clots (thrombosis). It belongs to a class of drugs called direct Factor Xa inhibitors, which work by blocking a key protein in the blood clotting process.
Uses & Indications
Dosage
Adults
For prophylaxis of DVT after hip replacement surgery: 10 mg once daily for 35 days. For prophylaxis of DVT after knee replacement surgery: 10 mg once daily for 10-14 days. For extended prophylaxis of DVT/PE: 10 mg once daily after at least 6 months of standard anticoagulant treatment.
Elderly
No dose adjustment required based on age, but caution is advised due to increased risk of bleeding.
Renal_impairment
For CrCl 15-50 mL/min: dose adjustment may be necessary for certain indications. For CrCl < 15 mL/min: generally not recommended.
How to Take
Take orally, with or without food for the 10 mg tablet. For specific indications, follow your doctor's instructions regarding food intake.
Mechanism of Action
Rivaroxaban is a highly selective direct inhibitor of Factor Xa. By inhibiting Factor Xa, it interrupts the intrinsic and extrinsic pathways of the blood coagulation cascade, inhibiting both thrombin generation and the development of thrombi. It does not require a co-factor (such as antithrombin III) for its activity.
Pharmacokinetics
Onset
Anticoagulant effect observed within 2-4 hours.
Excretion
Approximately 2/3 of the dose is excreted unchanged via the kidneys and 1/3 via the fecal route.
Half life
5-9 hours in young adults; 11-13 hours in elderly.
Absorption
Rapidly absorbed; absolute bioavailability is high (80-100%) for 2.5 mg and 10 mg doses, decreasing to 66% for 20 mg dose when taken without food. Peak concentrations are reached 2-4 hours after administration.
Metabolism
Primarily hepatic via CYP3A4, CYP2J2, and CYP-independent hydrolysis.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Hypersensitivity to rivaroxaban or any excipients.
- 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 under specific circumstances of switching anticoagulant therapy.
Drug Interactions
SSRIs/SNRIs
May increase the risk of bleeding.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
May decrease rivaroxaban exposure and efficacy.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
May increase rivaroxaban exposure and bleeding risk.
NSAIDs, aspirin, other antiplatelet agents, other anticoagulants
Increased risk of bleeding.
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, consider activated charcoal to reduce absorption. For severe bleeding, prothrombin complex concentrate (PCC) or activated prothrombin complex concentrate (aPCC) may be used. Recombinant Factor VIIa may also be considered.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for bleeding and fetal harm. Avoid use during lactation as rivaroxaban is excreted in breast milk.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Hypersensitivity to rivaroxaban or any excipients.
- 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 under specific circumstances of switching anticoagulant therapy.
Drug Interactions
SSRIs/SNRIs
May increase the risk of bleeding.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
May decrease rivaroxaban exposure and efficacy.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
May increase rivaroxaban exposure and bleeding risk.
NSAIDs, aspirin, other antiplatelet agents, other anticoagulants
Increased risk of bleeding.
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, consider activated charcoal to reduce absorption. For severe bleeding, prothrombin complex concentrate (PCC) or activated prothrombin complex concentrate (aPCC) may be used. Recombinant Factor VIIa may also be considered.
Pregnancy & Lactation
Not recommended during pregnancy due to potential for bleeding and fetal harm. Avoid use during lactation as rivaroxaban is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Globally available in pharmacies and hospitals.
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic versions available in many regions; originator patent expired or nearing expiration in some markets.
WHO Essential Medicine
YesClinical Trials
Rivaroxaban has been extensively studied in numerous large-scale clinical trials (e.g., ROCKET AF, EINSTEIN DVT, EINSTEIN PE, ATLAS ACS 2-TIMI 51) demonstrating its efficacy and safety across various indications.
Lab Monitoring
- Routine coagulation monitoring (e.g., PT/INR, aPTT) is not typically required. However, renal function should be monitored regularly, especially in elderly patients or those with kidney impairment. Hemoglobin and hematocrit should be checked periodically to monitor for bleeding.
Doctor Notes
- Assess renal and hepatic function before initiating therapy and periodically thereafter.
- Caution advised in patients at increased risk of bleeding (e.g., active ulcer disease, recent major bleeding).
- Counsel patients on signs of bleeding and the importance of adherence; emphasize no abrupt discontinuation.
Patient Guidelines
- Take Rivanex-10 mg exactly as prescribed by your doctor.
- Do not stop taking this medicine without consulting your doctor, as this may increase your risk of blood clots.
- Report any signs of unusual bleeding or bruising immediately to your doctor.
- Inform your doctor or dentist that you are taking Rivanex-10 mg before any surgery or dental procedure.
Missed Dose Advice
If you miss a dose of 10 mg, take it as soon as you remember. Do not take two doses at once to make up for a missed dose. Continue with your regular dosing schedule the next day.
Driving Precautions
Rivanex-10 mg may cause dizziness in some patients. If you experience dizziness, avoid driving or operating machinery.
Lifestyle Advice
- Be careful when performing activities that might cause injury or bleeding (e.g., shaving, brushing teeth, sports).
- Avoid alcohol consumption as it may increase the risk of bleeding.
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