Rivaban
Generic Name
Rivaroxaban
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rivaban 25 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Rivaroxaban is an oral anticoagulant used to prevent and treat various thromboembolic conditions. It is a direct Factor Xa inhibitor, meaning it directly blocks Factor Xa, an enzyme critical for the coagulation cascade, thereby reducing thrombin generation and blood clot formation. The 25 mg strength is not a standard therapeutic dose for Rivaroxaban and specific prescribing information for this strength may vary or not exist.
Uses & Indications
Dosage
Adults
The 25 mg strength is not a standard therapeutic dose for Rivaroxaban. Standard doses range from 2.5 mg to 20 mg daily depending on the indication. Patients should consult a physician for appropriate dosing based on their specific condition and medical history. If a 25 mg dose is prescribed, it would likely be for a specific, non-standard clinical situation.
Elderly
No specific dose adjustment is required based solely on age, but renal function should be monitored regularly as age is often associated with impaired renal function.
Renal_impairment
Dose adjustment is required for patients with moderate to severe renal impairment (e.g., creatinine clearance < 50 mL/min). A 25 mg dose would likely be contraindicated or require significant reduction in severe impairment due to increased risk of accumulation and bleeding.
How to Take
Take orally. For doses of 15 mg and 20 mg, Rivaroxaban should be taken with food to ensure adequate absorption. Doses of 2.5 mg and 10 mg can be taken with or without food. Swallow the tablet whole. If unable to swallow, the tablet may be crushed and mixed with water or applesauce immediately before administration.
Mechanism of Action
Rivaroxaban selectively and reversibly inhibits Factor Xa, which is involved in both the intrinsic and extrinsic pathways of the blood coagulation cascade. By inhibiting Factor Xa, it prevents the conversion of prothrombin to thrombin, ultimately reducing fibrin formation and clot development.
Pharmacokinetics
Onset
Onset of anticoagulant effect within 2-4 hours.
Excretion
Approximately 2/3 of the dose is excreted; about 1/3 renally as unchanged drug and inactive metabolites, and about 1/3 fecally as inactive metabolites.
Half life
5-9 hours in young adults, 11-13 hours in elderly patients.
Absorption
Rapidly absorbed. Oral bioavailability for 2.5 mg and 10 mg doses is high (80-100%), while for 15 mg and 20 mg it is approximately 66%. A 25 mg dose would likely have lower bioavailability similar to higher standard doses.
Metabolism
Primarily hepatic, 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 anticoagulants (e.g., unfractionated heparin, low molecular weight heparins, warfarin), unless specifically indicated for switching therapy
Drug Interactions
NSAIDs, Aspirin, other antiplatelet agents, SSRIs/SNRIs
Increased risk of bleeding. Use with caution and monitor for signs of bleeding.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased exposure to Rivaroxaban, leading to an increased risk of bleeding. Concomitant use is generally not recommended.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine)
Decreased exposure to Rivaroxaban, potentially leading to decreased efficacy. Concomitant use should be avoided.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Overdose of Rivaroxaban may lead to an increased risk of bleeding complications. Management includes symptomatic treatment and observation. Activated charcoal can be considered for recent ingestions. Specific reversal agents like prothrombin complex concentrate (PCC) or activated Factor VIIa may be used in severe, life-threatening bleeding.
Pregnancy & Lactation
Rivaroxaban is contraindicated during pregnancy due to the risk of bleeding and potential harm to the fetus. It is also not recommended during breastfeeding, as it is unknown whether Rivaroxaban is excreted in human milk and could pose a risk to the infant.
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 anticoagulants (e.g., unfractionated heparin, low molecular weight heparins, warfarin), unless specifically indicated for switching therapy
Drug Interactions
NSAIDs, Aspirin, other antiplatelet agents, SSRIs/SNRIs
Increased risk of bleeding. Use with caution and monitor for signs of bleeding.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased exposure to Rivaroxaban, leading to an increased risk of bleeding. Concomitant use is generally not recommended.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine)
Decreased exposure to Rivaroxaban, potentially leading to decreased efficacy. Concomitant use should be avoided.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Overdose of Rivaroxaban may lead to an increased risk of bleeding complications. Management includes symptomatic treatment and observation. Activated charcoal can be considered for recent ingestions. Specific reversal agents like prothrombin complex concentrate (PCC) or activated Factor VIIa may be used in severe, life-threatening bleeding.
Pregnancy & Lactation
Rivaroxaban is contraindicated during pregnancy due to the risk of bleeding and potential harm to the fetus. It is also not recommended during breastfeeding, as it is unknown whether Rivaroxaban is excreted in human milk and could pose a risk to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
3 years from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
FDA/DGDA approved (generic Rivaroxaban)
Patent Status
Patent protected (original compound, generics available)
Clinical Trials
Extensive clinical trials, such as ROCKET AF (for atrial fibrillation), EINSTEIN-DVT/PE (for DVT/PE treatment and prevention), and COMPASS (for CAD/PAD), have demonstrated the efficacy and safety profile of Rivaroxaban across its approved indications. Data for a 25 mg dose, however, would be outside the scope of these standard trials.
Lab Monitoring
- Renal function (creatinine clearance) should be assessed before initiation and periodically during treatment, especially in elderly patients or those with risk factors for renal impairment.
- Liver function tests (ALT, AST, bilirubin) should be monitored periodically.
- Hemoglobin and hematocrit levels should be checked periodically to detect occult bleeding.
Doctor Notes
- Verify the indication and ensure appropriate dose selection based on patient's renal function, age, and concomitant medications. The 25 mg strength is non-standard; confirm if this is an error or a specific compounded prescription.
- Educate patients thoroughly about bleeding risks and symptoms, and emphasize strict adherence to the dosing schedule.
- Carefully consider the risk-benefit profile in patients with increased bleeding risk or severe renal/hepatic impairment.
Patient Guidelines
- Take Rivaban exactly as prescribed by your doctor. Do not change the dose or stop taking it without consulting your doctor.
- Be vigilant for any signs of bleeding (e.g., unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stool) and report them immediately to your doctor.
- Inform all healthcare professionals (including dentists) that you are taking Rivaban before any surgery or invasive procedure.
- Carry an identification card stating that you are on anticoagulant therapy.
Missed Dose Advice
If a dose is missed, take it as soon as remembered on the same day. Do not take two doses at once to make up for a missed dose. Continue with the next scheduled dose as usual.
Driving Precautions
Rivaroxaban generally has no or negligible influence on the ability to drive and use machines. However, some patients may experience dizziness or fainting. Patients should be advised to know how they react to Rivaroxaban before driving or operating machinery.
Lifestyle Advice
- Avoid activities that carry a high risk of injury or trauma, which could lead to bleeding.
- Maintain good oral hygiene to prevent gum bleeding. Use a soft toothbrush and avoid aggressive flossing.
- Limit alcohol consumption, as excessive alcohol intake can increase the risk of bleeding.
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