Rivaban
Generic Name
Rivaroxaban
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rivaban 20 mg tablet | ৳ 45.00 | ৳ 450.00 |
Description
Overview of the medicine
Rivaroxaban is an oral anticoagulant used to prevent and treat blood clots in various conditions like nonvalvular atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE).
Uses & Indications
Dosage
Adults
For stroke prevention in nonvalvular AF: 20 mg orally once daily with the evening meal. For DVT/PE treatment: 15 mg orally twice daily for 21 days, then 20 mg orally once daily.
Elderly
No dose adjustment required based on age alone. Monitor renal function.
Renal_impairment
For nonvalvular AF: Moderate (CrCl 30-49 mL/min) - 15 mg orally once daily; Severe (CrCl <30 mL/min) - Not recommended.
How to Take
Take orally with food, preferably with the evening meal for certain indications (e.g., AF). Swallow the tablet whole. Do not crush or chew.
Mechanism of Action
Rivaroxaban selectively inhibits factor Xa, which is central to the coagulation cascade. By inhibiting factor Xa, it prevents the formation of thrombin and subsequent thrombus (blood clot) formation.
Pharmacokinetics
Onset
Anticoagulant effect observed within 2-4 hours.
Excretion
Approximately two-thirds renally (partially unchanged, partially as inactive metabolites) and one-third via hepatobiliary/fecal excretion.
Half life
5-9 hours in young adults; 11-13 hours in elderly subjects.
Absorption
Rapidly absorbed, with peak concentrations reached 2-4 hours post-dose. Bioavailability for 20 mg is approximately 66% when taken with food.
Metabolism
Primarily hepatic via cytochrome P450 (CYP) enzymes CYP3A4, CYP2J2, and non-CYP pathways.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Severe hypersensitivity to Rivaroxaban or any component of the tablet.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy and breastfeeding.
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Increased risk of bleeding. Concomitant use is generally not recommended.
NSAIDs, antiplatelet agents (e.g., aspirin, clopidogrel)
Increased risk of bleeding. Use with caution, especially in patients at high risk of bleeding.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased exposure to rivaroxaban, leading to increased bleeding risk. Concomitant use is generally not recommended.
Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine)
Decreased rivaroxaban exposure, potentially leading to reduced efficacy. Concomitant use should be avoided.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Rivaroxaban. Activated charcoal may be considered to reduce absorption if administered soon after overdose. Symptomatic treatment and management of bleeding are necessary.
Pregnancy & Lactation
Rivaroxaban is contraindicated during pregnancy and breastfeeding due to potential fetal bleeding risk and lack of data on excretion into breast milk. Alternative treatments should be considered.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- Severe hypersensitivity to Rivaroxaban or any component of the tablet.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy and breastfeeding.
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Increased risk of bleeding. Concomitant use is generally not recommended.
NSAIDs, antiplatelet agents (e.g., aspirin, clopidogrel)
Increased risk of bleeding. Use with caution, especially in patients at high risk of bleeding.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased exposure to rivaroxaban, leading to increased bleeding risk. Concomitant use is generally not recommended.
Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine)
Decreased rivaroxaban exposure, potentially leading to reduced efficacy. Concomitant use should be avoided.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Rivaroxaban. Activated charcoal may be considered to reduce absorption if administered soon after overdose. Symptomatic treatment and management of bleeding are necessary.
Pregnancy & Lactation
Rivaroxaban is contraindicated during pregnancy and breastfeeding due to potential fetal bleeding risk and lack of data on excretion into breast milk. Alternative treatments should be considered.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the manufacturing date, consult the packaging for specific expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Patent expired for generic formulation
WHO Essential Medicine
YesClinical Trials
Rivaroxaban's efficacy and safety have been established through extensive global clinical trial programs, including ROCKET AF (for atrial fibrillation), EINSTEIN-DVT, and EINSTEIN-PE (for DVT and PE treatment).
Lab Monitoring
- Routine coagulation monitoring (e.g., PT, aPTT, INR) is generally not required for Rivaroxaban. However, monitor hemoglobin levels periodically to detect occult bleeding. Assess renal function (CrCl) before initiating and during treatment, especially in patients with renal impairment.
Doctor Notes
- Emphasize strict adherence to the prescribed dosage and administration instructions to optimize efficacy and minimize bleeding risk.
- Thoroughly assess renal function (CrCl) and hepatic function before initiating Rivaroxaban and periodically thereafter.
- Counsel patients on signs of bleeding and when to seek immediate medical attention. Avoid co-administration with strong CYP3A4 inhibitors/inducers and other anticoagulants due to interaction risks.
Patient Guidelines
- Take Rivaban exactly as prescribed by your doctor and do not stop taking it without consulting them.
- Inform your doctor, dentist, or pharmacist that you are taking Rivaban before any surgery, dental procedure, or medical test.
- Report any signs of unusual bleeding or bruising immediately to your doctor.
- Carry an identification card stating that you are taking an anticoagulant.
Missed Dose Advice
If a dose is missed, take it as soon as you remember on the same day. 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
Rivaroxaban may cause dizziness, which could affect your ability to drive or operate machinery. If you experience dizziness, avoid these activities until you know how you react to the medication.
Lifestyle Advice
- Avoid activities that carry a high risk of injury or bleeding. Use a soft toothbrush and electric razor to minimize bleeding risk.
- Limit alcohol intake, as it may increase the risk of bleeding. Maintain a healthy diet and consult your doctor before taking any new medications, including over-the-counter drugs and herbal supplements.
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