Medicine Information

Rivarox

Name: Rivarox
Brand: Rivarox
Rating: 4.5 (117 reviews)

Tablet15 mgAnticoagulantsATC: B01AF01

Generic Name

Rivaroxaban

Manufacturer

Beximco Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
rivarox 15 mg tablet	৳ 35.00	৳ 350.00

Description

Overview of the medicine

Rivaroxaban is an anticoagulant medication used to treat and prevent blood clots. It is a direct factor Xa inhibitor, which works by blocking an enzyme involved in blood clotting.

Uses & Indications

Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation

Treatment of deep vein thrombosis (DVT)

Treatment of pulmonary embolism (PE)

Prevention of recurrent DVT and PE

Prophylaxis of DVT and PE in patients undergoing hip or knee replacement surgery

Dosage

Adults

For stroke prevention in non-valvular AF: 20 mg once daily (or 15 mg once daily for moderate-to-severe renal impairment). For DVT/PE treatment: 15 mg twice daily for 21 days, then 20 mg once daily.

Elderly

No specific dose adjustment based on age alone, but renal function should be assessed.

Renal_impairment

For non-valvular AF: CrCl 30-49 mL/min, 15 mg once daily. Not recommended for CrCl <15 mL/min.

How to Take

Take orally with food. For patients unable to swallow whole tablets, the tablet may be crushed and mixed with water or apple puree and administered orally, or via nasogastric tube immediately after preparation.

Mechanism of Action

Rivaroxaban is a highly selective direct Factor Xa (FXa) inhibitor. By inhibiting FXa, it prevents the generation of thrombin and the formation of blood clots. It does not require a cofactor like antithrombin III for its activity.

Pharmacokinetics

Onset

Anticoagulant effect observed within 2-4 hours.

Excretion

Approximately 2/3 excreted renally (about half as unchanged drug, half as inactive metabolites) and 1/3 hepatically via biliary and fecal routes.

Half life

5-9 hours in young adults; 11-13 hours in elderly.

Absorption

Rapidly absorbed, bioavailability is high (80-100%) for 10 mg and 15 mg doses taken with food.

Metabolism

Primarily metabolized in the liver via CYP3A4 and CYP2J2, and by CYP-independent hydrolysis.

Side Effects

Contraindications

Active pathological bleeding
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
Pregnancy and breastfeeding
Hypersensitivity to rivaroxaban or any component of the formulation
Concomitant treatment with other anticoagulants

Drug Interactions

Warfarin/Heparin

Concomitant use is contraindicated due to significantly increased bleeding risk.

NSAIDs/Aspirin/Other antiplatelet agents

Increased risk of bleeding.

Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)

Decreased exposure to rivaroxaban, leading to reduced efficacy.

Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)

Increased exposure to rivaroxaban, leading to increased bleeding risk.

Storage

Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.

Overdose

There is no specific antidote for rivaroxaban. Activated charcoal can be considered to reduce absorption. Symptomatic treatment and management of bleeding complications should be provided. Andexanet alfa is a reversal agent for rivaroxaban.

Pregnancy & Lactation

Contraindicated during pregnancy and breastfeeding due to potential for bleeding and lack of safety data.

Side Effects

Contraindications

Active pathological bleeding
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
Pregnancy and breastfeeding
Hypersensitivity to rivaroxaban or any component of the formulation
Concomitant treatment with other anticoagulants

Drug Interactions

Warfarin/Heparin

Concomitant use is contraindicated due to significantly increased bleeding risk.

NSAIDs/Aspirin/Other antiplatelet agents

Increased risk of bleeding.

Strong CYP3A4 inducers (e.g., rifampicin, phenytoin)

Decreased exposure to rivaroxaban, leading to reduced efficacy.

Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)

Increased exposure to rivaroxaban, leading to increased bleeding risk.

Storage

Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.

Overdose

Pregnancy & Lactation

Contraindicated during pregnancy and breastfeeding due to potential for bleeding and lack of safety data.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

10 tablets30 tablets

Shelf Life

Typically 24-36 months

Availability

Pharmacies, hospitals

Approval Status

Approved by FDA and many regulatory bodies worldwide

Patent Status

Patent expired in some regions, generic versions available

Clinical Trials

Numerous clinical trials (e.g., ROCKET AF, EINSTEIN-DVT, EINSTEIN-PE) have established the efficacy and safety of rivaroxaban across its approved indications.

Lab Monitoring

Routine coagulation monitoring (e.g., PT, aPTT, INR) is generally not required for rivaroxaban. Assess renal function periodically. Monitor for signs and symptoms of bleeding.

Doctor Notes

Careful assessment of bleeding risk factors is crucial before initiating therapy.
Regular monitoring of renal function is important.
Avoid concomitant use with other systemic anticoagulants.
Educate patients on bleeding symptoms and the importance of adherence.

Patient Guidelines

Take as directed by your doctor, with food.
Do not stop taking this medicine without consulting your doctor, as it may increase your risk of blood clots.
Report any unusual bleeding or bruising immediately to your doctor.
Inform your dentist or any healthcare provider that you are taking rivaroxaban before any surgery or procedure.

Missed Dose Advice

If you miss a dose of 15 mg twice daily regimen, take it as soon as you remember, but do not take two doses at the same time to make up for a missed dose. If you miss a dose of once daily regimen, take it as soon as you remember, but do not take more than one tablet in a single day.

Driving Precautions

Rivaroxaban has no or negligible influence on the ability to drive and use machines. However, some patients may experience dizziness or syncope, which could affect their ability to drive or operate machinery.