Rivarin
Generic Name
Rivaroxaban
Manufacturer
MediCare Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rivarin 200 mg capsule | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Rivarin 200 mg Capsule contains Rivaroxaban, a direct Factor Xa inhibitor, used to prevent and treat various thromboembolic conditions. This 200 mg strength is exceptionally high and deviates significantly from standard therapeutic doses for Rivaroxaban, which typically range from 2.5 mg to 20 mg. It is crucial to consult a healthcare professional regarding its appropriate use, if any, as such a high dose can lead to severe bleeding risks.
Uses & Indications
Dosage
Adults
The standard therapeutic doses of Rivaroxaban range from 2.5 mg to 20 mg daily, depending on the indication. A 200 mg dose is far beyond the typical therapeutic range and would generally be considered an overdose, leading to a significantly increased risk of bleeding. This specific 200 mg capsule is not for routine use and its administration must be based on highly specialized medical judgment or a clinical trial protocol, if applicable.
Elderly
No specific dose adjustment is generally required for elderly patients with standard doses, but close monitoring for bleeding is recommended. A 200 mg dose would carry an even higher risk in the elderly.
Renal_impairment
For standard doses, dose adjustment is necessary in patients with severe renal impairment (CrCl < 30 mL/min). Rivaroxaban is not recommended for patients with CrCl < 15 mL/min. A 200 mg dose would be extremely dangerous in renally impaired patients and is strictly contraindicated.
How to Take
Take the capsule orally with food, as directed by a healthcare professional. Ensure proper hydration. Given the unusual strength, extreme caution is advised.
Mechanism of Action
Rivaroxaban is a highly selective direct inhibitor of Factor Xa. By inhibiting Factor Xa, it prevents the generation of thrombin and the formation of blood clots, thereby exerting its anticoagulant effect.
Pharmacokinetics
Onset
Anticoagulant effect observed within 2-4 hours.
Excretion
Approximately 2/3 of the dose is eliminated via the kidneys, with about half excreted unchanged. The remaining 1/3 is eliminated via the hepatobiliary route.
Half life
Typically 5-9 hours in young adults and 11-13 hours in elderly patients.
Absorption
Rapidly absorbed, peak plasma concentrations typically occur 2-4 hours after administration. Bioavailability is high (80-100%) for 10 mg and 15 mg doses, but decreases at higher doses (e.g., 20 mg: 66%). For a 200 mg capsule, bioavailability would be significantly lower.
Metabolism
Metabolized primarily by CYP3A4, CYP2J2, and non-CYP dependent mechanisms.
Side Effects
Contraindications
- Hypersensitivity to Rivaroxaban or any component of the capsule
- Active clinically significant bleeding (e.g., gastrointestinal bleeding, intracranial bleeding)
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- Concomitant treatment with other anticoagulants (e.g., unfractionated heparin, low molecular weight heparins, warfarin, dabigatran, apixaban) except under specific circumstances (e.g., during transition to or from Rivaroxaban).
- Renal impairment with CrCl < 15 mL/min (absolute contraindication for 200 mg)
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Significantly increased risk of bleeding. Concomitant use is generally contraindicated.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
Decreased exposure to Rivaroxaban, potentially reducing its efficacy.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased exposure to Rivaroxaban, leading to an increased risk of bleeding. Concomitant use with a 200 mg dose is extremely hazardous.
NSAIDs and antiplatelet agents (e.g., aspirin, clopidogrel)
Increased risk of bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
An overdose of Rivaroxaban, especially with a 200 mg dose, carries a very high risk of bleeding complications. Symptoms may include epistaxis, hematoma, hematuria, gastrointestinal bleeding, or intracranial hemorrhage. Management involves discontinuing the drug, administering activated charcoal (if recent ingestion), and supportive care. Andexanet alfa is a specific antidote for Factor Xa inhibitors and may be used in life-threatening bleeding situations. Hemodialysis is not effective.
Pregnancy & Lactation
Rivaroxaban is not recommended during pregnancy due to the risk of bleeding and potential harm to the fetus. It should be avoided in breastfeeding women as it is excreted into breast milk. A risk-benefit assessment should be made by a specialist.
Side Effects
Contraindications
- Hypersensitivity to Rivaroxaban or any component of the capsule
- Active clinically significant bleeding (e.g., gastrointestinal bleeding, intracranial bleeding)
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
- Concomitant treatment with other anticoagulants (e.g., unfractionated heparin, low molecular weight heparins, warfarin, dabigatran, apixaban) except under specific circumstances (e.g., during transition to or from Rivaroxaban).
- Renal impairment with CrCl < 15 mL/min (absolute contraindication for 200 mg)
Drug Interactions
Other anticoagulants (e.g., warfarin, heparin)
Significantly increased risk of bleeding. Concomitant use is generally contraindicated.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)
Decreased exposure to Rivaroxaban, potentially reducing its efficacy.
Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased exposure to Rivaroxaban, leading to an increased risk of bleeding. Concomitant use with a 200 mg dose is extremely hazardous.
NSAIDs and antiplatelet agents (e.g., aspirin, clopidogrel)
Increased risk of bleeding.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
An overdose of Rivaroxaban, especially with a 200 mg dose, carries a very high risk of bleeding complications. Symptoms may include epistaxis, hematoma, hematuria, gastrointestinal bleeding, or intracranial hemorrhage. Management involves discontinuing the drug, administering activated charcoal (if recent ingestion), and supportive care. Andexanet alfa is a specific antidote for Factor Xa inhibitors and may be used in life-threatening bleeding situations. Hemodialysis is not effective.
Pregnancy & Lactation
Rivaroxaban is not recommended during pregnancy due to the risk of bleeding and potential harm to the fetus. It should be avoided in breastfeeding women as it is excreted into breast milk. A risk-benefit assessment should be made by a specialist.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies and Hospitals nationwide
Approval Status
Approved in Bangladesh by DGDA
Patent Status
Generic versions available
WHO Essential Medicine
YesClinical Trials
While extensive clinical trials have established the safety and efficacy of Rivaroxaban at standard therapeutic doses (2.5 mg to 20 mg), specific clinical trial data for a 200 mg Rivaroxaban capsule are not publicly available and would be considered highly unusual for standard indications.
Lab Monitoring
- No routine coagulation monitoring is required for Rivaroxaban. However, for a 200 mg dose, frequent complete blood count (CBC) to monitor hemoglobin and hematocrit, and renal function tests (creatinine, CrCl) are essential. Liver function tests (LFTs) should also be monitored.
- Anti-Factor Xa activity assays may be used in specific clinical situations (e.g., overdose, emergency surgery) but are not routinely available or recommended.
Doctor Notes
- Emphasize that Rivarin 200 mg Capsule represents a highly unusual and potentially dangerous dose of Rivaroxaban. Standard therapeutic doses range from 2.5 mg to 20 mg. Prescribing or administering this strength must be based on extraordinary clinical justification or a specific research protocol.
- Patients on this dosage require extremely close monitoring for signs of bleeding, and immediate intervention protocols for overdose should be in place.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, even if the dose seems unusually high.
- Report any signs of bleeding (e.g., unusual bruising, prolonged nosebleeds, red or dark stools, pink or brown urine) immediately to your doctor.
- Do not stop taking Rivarin 200 mg Capsule without consulting your doctor, as this may increase your risk of clotting events.
- Inform your dentist or any other healthcare provider that you are taking this medicine before any procedure.
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. Consult your doctor if unsure, especially given the high strength of this particular capsule.
Driving Precautions
Rivarin 200 mg Capsule is unlikely to directly affect your ability to drive or operate machinery. However, if you experience side effects like dizziness, avoid these activities.
Lifestyle Advice
- Avoid activities that may increase your risk of bleeding or injury.
- Limit alcohol consumption.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Maintain good oral hygiene to prevent gum bleeding.
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