Rovanox
Generic Name
Rivaroxaban
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rovanox 100 mg injection | ৳ 300.00 | N/A |
Description
Overview of the medicine
Rovanox (Rivaroxaban) is an oral anticoagulant used to prevent and treat blood clots in various conditions like deep vein thrombosis (DVT), pulmonary embolism (PE), and to reduce the risk of stroke in patients with non-valvular atrial fibrillation.
Uses & Indications
Dosage
Adults
For NVAF: 20 mg once daily with food. For DVT/PE treatment: 15 mg twice daily for 21 days, then 20 mg once daily. For DVT/PE prevention post-surgery: 10 mg once daily.
Elderly
No dose adjustment generally required based on age alone, but assess renal function carefully.
Renal_impairment
For NVAF with CrCl 15-50 mL/min: 15 mg once daily with food. Not recommended for CrCl < 15 mL/min.
How to Take
Take orally with food. For doses of 15 mg and 20 mg, it is particularly important to take with food to ensure adequate absorption.
Mechanism of Action
Rivaroxaban is a highly selective direct inhibitor of Factor Xa, which is a key enzyme in the coagulation cascade. By inhibiting Factor Xa, it prevents both thrombin generation and clot formation.
Pharmacokinetics
Onset
Onset of anticoagulant effect within 2-4 hours.
Excretion
Approximately 2/3 of the dose is eliminated via the kidneys (1/3 as unchanged drug, 1/3 as inactive metabolites), and 1/3 via the fecal route as inactive metabolites.
Half life
5-9 hours in young adults, 11-13 hours in elderly.
Absorption
Rapidly absorbed, with peak concentrations reached in 2-4 hours. Oral bioavailability is high (80-100%) for 10 mg and lower for 15 mg and 20 mg when not taken with food.
Metabolism
Metabolized in the liver primarily by CYP3A4, CYP2J2, and non-CYP pathways.
Side Effects
Contraindications
- Hypersensitivity to Rivaroxaban or any component of the formulation.
- Active pathological bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage).
- Severe hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Concomitant treatment with other anticoagulants (e.g., unfractionated heparin, low molecular weight heparins, other oral anticoagulants) except when switching therapy or when unfractionated heparin is given to maintain patency of a central venous or arterial catheter.
Drug Interactions
0
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase exposure to Rivaroxaban, leading to increased bleeding risk.
1
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin) may decrease Rivaroxaban exposure, leading to reduced efficacy.
2
Other anticoagulants (e.g., warfarin, heparin) or antiplatelet agents (e.g., aspirin, clopidogrel) can increase the risk of bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to an increased risk of bleeding. Management includes discontinuation of Rivaroxaban and observation for bleeding. Activated charcoal can be considered to reduce absorption if taken recently. Specific antidote Andexxa (andexanet alfa) is available in some regions to reverse Factor Xa inhibitor activity.
Pregnancy & Lactation
Not recommended during pregnancy and lactation due to potential for bleeding and lack of sufficient safety data. Females of reproductive potential should use effective contraception during treatment.
Side Effects
Contraindications
- Hypersensitivity to Rivaroxaban or any component of the formulation.
- Active pathological bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage).
- Severe hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Concomitant treatment with other anticoagulants (e.g., unfractionated heparin, low molecular weight heparins, other oral anticoagulants) except when switching therapy or when unfractionated heparin is given to maintain patency of a central venous or arterial catheter.
Drug Interactions
0
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase exposure to Rivaroxaban, leading to increased bleeding risk.
1
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin) may decrease Rivaroxaban exposure, leading to reduced efficacy.
2
Other anticoagulants (e.g., warfarin, heparin) or antiplatelet agents (e.g., aspirin, clopidogrel) can increase the risk of bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to an increased risk of bleeding. Management includes discontinuation of Rivaroxaban and observation for bleeding. Activated charcoal can be considered to reduce absorption if taken recently. Specific antidote Andexxa (andexanet alfa) is available in some regions to reverse Factor Xa inhibitor activity.
Pregnancy & Lactation
Not recommended during pregnancy and lactation due to potential for bleeding and lack of sufficient safety data. Females of reproductive potential should use effective contraception during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved by FDA and DGDA (Bangladesh)
Patent Status
Generally patented, though generic versions may be available in some regions.
Clinical Trials
Rivaroxaban has been extensively studied in various large-scale clinical trials, including ROCKET AF for atrial fibrillation, EINSTEIN DVT/PE for venous thromboembolism, and RECORD series for orthopedic surgery prophylaxis, demonstrating its efficacy and safety.
Lab Monitoring
- Routine coagulation monitoring (e.g., PT, aPTT, INR) is generally not required for Rivaroxaban. However, specific anti-Factor Xa assays can be used to measure Rivaroxaban levels if clinically necessary (e.g., in overdose or for surgical planning).
Doctor Notes
- Emphasize the importance of patient education regarding bleeding signs and symptoms.
- Careful assessment of renal function is crucial before initiating and during therapy, especially in elderly patients.
- Avoid abrupt discontinuation due to increased risk of thrombotic events.
- Consider specific reversal agents (e.g., Andexxa) in cases of life-threatening bleeding where available.
Patient Guidelines
- Take Rovanox exactly as prescribed by your doctor, do not miss doses.
- Always take 15 mg and 20 mg doses with food.
- Do not stop taking Rovanox without consulting your doctor, as this may increase your risk of blood clots.
- Be aware of signs of bleeding (e.g., unusual bruising, prolonged bleeding from cuts, red or dark urine/stools) and report them immediately to your doctor.
Missed Dose Advice
If taking once daily: Take the dose as soon as you remember on the same day. Do not take two doses at once. If taking twice daily (for 15 mg during initial DVT/PE treatment): You may take two 15 mg tablets at the same time to ensure you get 30 mg daily. On the next day, continue with your regular schedule.
Driving Precautions
Rovanox is unlikely to affect your ability to drive or operate machinery. However, if you experience side effects like dizziness, do not drive or operate machinery.
Lifestyle Advice
- Avoid activities that may lead to injury or bleeding.
- Inform all healthcare providers (including dentists) that you are taking an anticoagulant before any procedure.
- Limit alcohol intake, as it may increase bleeding risk.
- Maintain a healthy diet and stay hydrated.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Rovanox Brand
Other medicines available under the same brand name
