Rivarox
Generic Name
Rivaroxaban 10 mg Tablet
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rivarox 10 mg tablet | ৳ 25.00 | ৳ 250.00 |
Description
Overview of the medicine
Rivaroxaban is an anticoagulant medication used to prevent and treat blood clots. It belongs to a class of drugs called direct factor Xa inhibitors.
Uses & Indications
Dosage
Adults
Dosage varies by indication. For DVT prophylaxis after major orthopedic surgery: 10 mg once daily. For stroke prevention in non-valvular AF with severe renal impairment (CrCl 15-50 mL/min): 15 mg once daily. For other indications (DVT/PE treatment), higher doses (15 mg or 20 mg) are typically used.
Elderly
No specific dose adjustment solely based on age is required; however, renal function should be considered, which declines with age.
Renal_impairment
Dose adjustment needed. For CrCl 15-50 mL/min in non-valvular AF, reduce to 15 mg once daily. Contraindicated in CrCl <15 mL/min.
How to Take
Take orally. The 10 mg dose can be taken with or without food. For 15 mg and 20 mg doses, Rivaroxaban must be taken with food to ensure adequate absorption. Preferably take at the same time each day.
Mechanism of Action
Rivaroxaban selectively inhibits Factor Xa, a key enzyme in the coagulation cascade. This inhibition prevents thrombin generation and subsequent clot formation, thereby reducing the risk of thrombotic events.
Pharmacokinetics
Onset
Anticoagulant effect seen within 2-4 hours.
Excretion
Approximately 2/3 excreted via the renal route (1/3 as unchanged drug, 1/3 as inactive metabolites) and 1/3 via the fecal/biliary route.
Half life
5-9 hours in healthy individuals, 11-13 hours in elderly or those with renal impairment.
Absorption
Rapidly absorbed with peak plasma concentrations occurring 2-4 hours after oral administration. Bioavailability is high (80-100%) for 10 mg.
Metabolism
Metabolized primarily by CYP3A4, CYP2J2, and non-CYP mechanisms.
Side Effects
Contraindications
- Active pathological bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage).
- Severe hypersensitivity reaction to rivaroxaban.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Concomitant treatment with other anticoagulants (except when switching therapy or receiving unfractionated heparin at doses necessary to maintain a patent central venous or arterial catheter).
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Greatly increased bleeding risk. Contraindicated.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
Decreased rivaroxaban exposure, reduced efficacy. Avoid concomitant use.
NSAIDs, antiplatelet agents (e.g., aspirin, clopidogrel)
Increased bleeding risk. Use with caution.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased rivaroxaban exposure, increased bleeding risk. Avoid concomitant use.
Storage
Store below 30°C (86°F), protect from moisture and light. Keep out of reach of children.
Overdose
Overdose increases the risk of bleeding. Treatment involves symptomatic and supportive measures. Activated charcoal can be considered if taken recently. Specific antidote Andexanet alfa is available for reversal in life-threatening bleeding.
Pregnancy & Lactation
Pregnancy: Category C. Not recommended during pregnancy unless potential benefit outweighs risk. Lactation: Not recommended during breastfeeding due to potential for serious adverse reactions in the infant. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Active pathological bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage).
- Severe hypersensitivity reaction to rivaroxaban.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Concomitant treatment with other anticoagulants (except when switching therapy or receiving unfractionated heparin at doses necessary to maintain a patent central venous or arterial catheter).
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Greatly increased bleeding risk. Contraindicated.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
Decreased rivaroxaban exposure, reduced efficacy. Avoid concomitant use.
NSAIDs, antiplatelet agents (e.g., aspirin, clopidogrel)
Increased bleeding risk. Use with caution.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased rivaroxaban exposure, increased bleeding risk. Avoid concomitant use.
Storage
Store below 30°C (86°F), protect from moisture and light. Keep out of reach of children.
Overdose
Overdose increases the risk of bleeding. Treatment involves symptomatic and supportive measures. Activated charcoal can be considered if taken recently. Specific antidote Andexanet alfa is available for reversal in life-threatening bleeding.
Pregnancy & Lactation
Pregnancy: Category C. Not recommended during pregnancy unless potential benefit outweighs risk. Lactation: Not recommended during breastfeeding due to potential for serious adverse reactions in the infant. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years, depending on specific manufacturer and formulation.
Availability
Pharmacies, Hospitals
Approval Status
FDA approved
Patent Status
Patent expired in some regions, generic available
Clinical Trials
Key clinical trials include ROCKET AF (stroke prevention in AF), EINSTEIN-DVT and EINSTEIN-PE (DVT/PE treatment and prevention), and ATLAS ACS 2-TIMI 51 (secondary prevention in ACS).
Lab Monitoring
- Routine coagulation monitoring (e.g., PT/INR, aPTT) is not required for therapeutic purposes.
- Monitor renal function regularly, especially in elderly and renally impaired patients.
- Monitor for signs and symptoms of bleeding.
- Hemoglobin/hematocrit if bleeding is suspected.
Doctor Notes
- Careful assessment of bleeding risk versus thrombotic risk is crucial before initiating and during treatment.
- Monitor renal function, especially in elderly and renally impaired patients, as dose adjustments may be necessary.
- Thoroughly educate patients on bleeding signs and symptoms, importance of adherence, and drug interactions.
Patient Guidelines
- Take Rivaroxaban exactly as directed by your doctor, do not stop without consultation.
- Report any unusual bleeding, bruising, or adverse reactions immediately to your doctor.
- Inform all healthcare providers, including dentists and pharmacists, that you are taking rivaroxaban.
- Do not take other medications, especially NSAIDs or aspirin, without consulting your doctor.
Missed Dose Advice
For once-daily dosing (e.g., 10 mg): Take the missed dose immediately if remembered on the same day, then continue with the next dose as usual the following day. Do not take two doses at once. For twice-daily dosing (e.g., 15 mg): Take immediately to ensure total 30 mg/day, and continue with normal schedule. Two 15 mg doses can be taken at the same time if needed.
Driving Precautions
Rivaroxaban may cause dizziness or syncope, which could affect the ability to drive or operate machinery. Patients should be aware of how they react to the medication before driving or performing tasks requiring alertness.
Lifestyle Advice
- Avoid activities that carry a high risk of injury or trauma to minimize bleeding.
- Use a soft toothbrush and an electric shaver to reduce the risk of bleeding.
- Limit alcohol consumption as it may increase bleeding risk.
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