Xelitor
Generic Name
Rivaroxaban 20 mg
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xelitor 20 mg tablet | ৳ 18.05 | N/A |
Description
Overview of the medicine
Rivaroxaban is an oral anticoagulant used to prevent and treat blood clots (thrombosis) in various conditions, including non-valvular atrial fibrillation, deep vein thrombosis, and pulmonary embolism.
Uses & Indications
Dosage
Adults
For NVAF: 20 mg once daily with the evening meal. For DVT/PE treatment: 15 mg twice daily for 21 days, followed by 20 mg once daily.
Elderly
No specific dose adjustment is needed based solely on age, but renal function should be assessed.
Renal_impairment
Moderate (CrCl 30-49 mL/min): 15 mg once daily for NVAF. Severe (CrCl 15-29 mL/min): generally avoided or careful monitoring; 15 mg once daily may be considered for NVAF if benefit outweighs risk. Not recommended in CrCl < 15 mL/min.
How to Take
Take orally with food. The 20 mg tablet should be taken with the evening meal to ensure optimal absorption.
Mechanism of Action
Rivaroxaban is a direct Factor Xa inhibitor. It selectively and competitively blocks Factor Xa, an enzyme that plays a critical role in the coagulation cascade. By inhibiting Factor Xa, it prevents the conversion of prothrombin to thrombin, thereby reducing thrombin generation and preventing clot formation.
Pharmacokinetics
Onset
Anticoagulant effect occurs within 2-4 hours after oral administration.
Excretion
Approximately two-thirds of the dose is excreted, with about one-third renally as unchanged drug and inactive metabolites, and one-third via the fecal route.
Half life
The terminal elimination half-life is 5-9 hours in young adults and 11-13 hours in elderly patients.
Absorption
Rapidly absorbed from the gastrointestinal tract. Oral bioavailability for the 20 mg tablet is approximately 66% when taken with food.
Metabolism
Metabolized primarily in the liver by CYP3A4, CYP2J2, and CYP-independent hydrolysis.
Side Effects
Contraindications
- Hypersensitivity to rivaroxaban or any component of the tablet.
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy and lactation.
Drug Interactions
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
May increase rivaroxaban exposure and increase bleeding risk. Concomitant use is generally not recommended.
NSAIDs, Aspirin, other antiplatelet agents, other anticoagulants
Increased risk of bleeding when co-administered.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine)
May decrease rivaroxaban exposure and reduce its efficacy. Avoid concomitant use.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose of rivaroxaban may lead to an increased risk of bleeding. Management involves supportive care and symptomatic treatment. Activated charcoal can be administered shortly after ingestion to reduce absorption. Andexanet alfa is a specific reversal agent available for severe, uncontrolled bleeding.
Pregnancy & Lactation
Rivaroxaban is contraindicated during pregnancy and lactation due to the potential for bleeding and lack of sufficient data on safety. Use should be avoided.
Side Effects
Contraindications
- Hypersensitivity to rivaroxaban or any component of the tablet.
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy and lactation.
Drug Interactions
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
May increase rivaroxaban exposure and increase bleeding risk. Concomitant use is generally not recommended.
NSAIDs, Aspirin, other antiplatelet agents, other anticoagulants
Increased risk of bleeding when co-administered.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine)
May decrease rivaroxaban exposure and reduce its efficacy. Avoid concomitant use.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose of rivaroxaban may lead to an increased risk of bleeding. Management involves supportive care and symptomatic treatment. Activated charcoal can be administered shortly after ingestion to reduce absorption. Andexanet alfa is a specific reversal agent available for severe, uncontrolled bleeding.
Pregnancy & Lactation
Rivaroxaban is contraindicated during pregnancy and lactation due to the potential for bleeding and lack of sufficient data on safety. Use should be avoided.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the manufacturing date, check packaging for exact expiry.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA (US), EMA (EU), DGDA (Bangladesh)
Patent Status
Generally off-patent in many countries, but may vary by specific formulation/manufacturer
Clinical Trials
Rivaroxaban's efficacy and safety have been established through extensive clinical trials such as ROCKET AF (atrial fibrillation), EINSTEIN-DVT, EINSTEIN-PE (DVT/PE treatment), and COMPASS (CAD/PAD).
Lab Monitoring
- No routine coagulation monitoring (e.g., PT, aPTT) is required for rivaroxaban. However, renal function should be monitored periodically. Factor Xa activity assays may be used in specific clinical situations (e.g., overdose or emergency).
Doctor Notes
- Assess renal function prior to initiation and periodically thereafter, adjusting dose as needed for NVAF in moderate renal impairment.
- Educate patients thoroughly on bleeding signs and symptoms and the importance of adherence and not missing doses.
- Consider bleeding risk factors carefully, especially when co-administering with other agents affecting hemostasis.
- Andexanet alfa is a specific reversal agent for severe bleeding, confirm availability in your region.
Patient Guidelines
- Take Xelitor exactly as prescribed by your doctor, with food, preferably with your evening meal.
- Do not stop taking Xelitor without consulting your doctor, as this may increase your risk of blood clots.
- Report any unusual bleeding or bruising, severe headache, or dizziness to your doctor immediately.
- Inform all your healthcare providers, including dentists, that you are taking Xelitor before any surgery or procedure.
Missed Dose Advice
If you are taking Xelitor 20 mg once daily and forget a dose, take it immediately if you remember on the same day. Do not take two doses at once to make up for a missed dose. Resume your regular schedule the next day.
Driving Precautions
Xelitor may cause dizziness, which could impair your ability to drive or operate machinery. Exercise caution and avoid these activities if you experience dizziness.
Lifestyle Advice
- Avoid activities that have a high risk of injury or bleeding (e.g., contact sports).
- Use soft toothbrushes and electric razors to minimize bleeding risks.
- Limit alcohol consumption as it may increase the risk of bleeding.
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