Xelitor
Generic Name
Rivaroxaban
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
xelitor 10 mg tablet | ৳ 10.03 | N/A |
Description
Overview of the medicine
Xelitor 10 mg Tablet contains Rivaroxaban, which is an anticoagulant (blood thinner). It is used to prevent and treat blood clots in various conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent stroke in patients with non-valvular atrial fibrillation.
Uses & Indications
Dosage
Adults
For VTE prophylaxis post-orthopedic surgery: 10 mg once daily. For other indications, dosage varies, please consult doctor.
Elderly
No specific dose adjustment is required based on age, but renal function should be assessed.
Renal_impairment
For creatinine clearance 15-49 mL/min, use with caution. Not recommended for CrCl <15 mL/min.
How to Take
Take orally, with or without food. For 15 mg and 20 mg doses, it should be taken with food.
Mechanism of Action
Rivaroxaban is a direct, selective Factor Xa inhibitor. By inhibiting Factor Xa, it prevents the conversion of prothrombin to thrombin, thereby inhibiting thrombus formation and overall coagulation cascade.
Pharmacokinetics
Onset
Anticoagulant effect observed within 2-4 hours.
Excretion
Approximately 2/3 eliminated renally (1/3 as unchanged drug, 1/3 as inactive metabolites) and 1/3 via fecal/biliary route (half as unchanged drug, half as inactive metabolites).
Half life
5-9 hours in young adults, 11-13 hours in elderly.
Absorption
Rapidly absorbed, with peak concentrations reached 2-4 hours after administration. Bioavailability is high (80-100%) for 10 mg dose, irrespective of food.
Metabolism
Metabolized in the liver via CYP3A4, CYP2J2, and CYP-independent hydrolysis.
Side Effects
Contraindications
- Active pathological bleeding (e.g., gastrointestinal bleeding, intracranial haemorrhage).
- Hypersensitivity to Rivaroxaban or any excipients.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy and breastfeeding.
- Concomitant treatment with other anticoagulants.
Drug Interactions
Other Anticoagulants (e.g., Heparin, Warfarin)
Increased bleeding risk. Avoid concomitant use unless under strict medical supervision for specific indications.
Strong CYP3A4 inducers (e.g., Rifampicin, Phenytoin)
May decrease Rivaroxaban exposure and reduce its effect. Avoid concomitant use.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Rivaroxaban exposure and bleeding risk. Avoid concomitant use.
NSAIDs and Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased bleeding risk. Use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose of Rivaroxaban increases the risk of bleeding. Management includes activated charcoal to reduce absorption if taken recently, mechanical compression for localized bleeding, and consideration of specific reversal agent (Andexanet alfa) if available and clinically indicated.
Pregnancy & Lactation
Xelitor is contraindicated during pregnancy and breastfeeding due to potential fetal harm and unknown risk to infants. Women of childbearing potential should use effective contraception during treatment.
Side Effects
Contraindications
- Active pathological bleeding (e.g., gastrointestinal bleeding, intracranial haemorrhage).
- Hypersensitivity to Rivaroxaban or any excipients.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy and breastfeeding.
- Concomitant treatment with other anticoagulants.
Drug Interactions
Other Anticoagulants (e.g., Heparin, Warfarin)
Increased bleeding risk. Avoid concomitant use unless under strict medical supervision for specific indications.
Strong CYP3A4 inducers (e.g., Rifampicin, Phenytoin)
May decrease Rivaroxaban exposure and reduce its effect. Avoid concomitant use.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May increase Rivaroxaban exposure and bleeding risk. Avoid concomitant use.
NSAIDs and Antiplatelet agents (e.g., Aspirin, Clopidogrel)
Increased bleeding risk. Use with caution.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose of Rivaroxaban increases the risk of bleeding. Management includes activated charcoal to reduce absorption if taken recently, mechanical compression for localized bleeding, and consideration of specific reversal agent (Andexanet alfa) if available and clinically indicated.
Pregnancy & Lactation
Xelitor is contraindicated during pregnancy and breastfeeding due to potential fetal harm and unknown risk to infants. Women of childbearing potential should use effective contraception during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies and hospitals
Approval Status
Approved by DGDA and other regulatory bodies
Patent Status
Generic available
Clinical Trials
Rivaroxaban has been extensively studied in various clinical trials (e.g., RECORD, ROCKET AF, EINSTEIN, COMPASS) demonstrating its efficacy and safety for approved indications.
Lab Monitoring
- Routine coagulation monitoring (e.g., PT, aPTT) is not required. Monitor renal function periodically, especially in elderly or renally impaired patients. Monitor hemoglobin and hematocrit for signs of bleeding.
Doctor Notes
- Assess renal function (CrCl) before initiating and periodically during treatment.
- Evaluate bleeding risk factors (e.g., concomitant medications, active ulcers) prior to prescribing.
- Educate patients on bleeding symptoms and the importance of adherence, and not to discontinue without medical advice.
- Consider reversal agents (e.g., Andexanet alfa) in cases of life-threatening bleeding.
Patient Guidelines
- Take Xelitor exactly as prescribed by your doctor.
- Do not stop taking Xelitor without consulting your doctor, as this may increase your risk of blood clots.
- Inform your doctor or dentist about taking Xelitor before any surgery or dental procedure.
- Report any signs of unusual bleeding or bruising immediately to your doctor.
Missed Dose Advice
If you miss a dose of Xelitor 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.
Driving Precautions
Dizziness is a possible side effect of Xelitor. If you experience dizziness, avoid driving or operating machinery.
Lifestyle Advice
- Avoid activities that carry a high risk of injury or bleeding.
- Inform all healthcare providers, including pharmacists, about all medications you are taking.
- Limit alcohol consumption, as it can increase the risk of bleeding.
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