Rivaroxaban Medical Valley
Direct Factor Xa Inhibitor — Oral Anticoagulant (2.5 mg Film-Coated Tablets)
Quick Facts: Rivaroxaban Medical Valley
Key Takeaways
- Always taken with aspirin: Rivaroxaban Medical Valley 2.5 mg is never used alone — it must be combined with aspirin (75–100 mg daily), and sometimes with clopidogrel or ticlopidine
- Reduces cardiovascular events: Clinically proven to reduce the risk of heart attack, stroke, and cardiovascular death in high-risk patients with acute coronary syndrome, coronary artery disease, or peripheral arterial disease
- Bleeding risk is the main concern: As with all anticoagulants, the most significant risk is bleeding, which can be serious or life-threatening — seek immediate medical attention for unusual bleeding
- Do not stop without medical advice: Stopping Rivaroxaban Medical Valley abruptly can increase the risk of a new heart attack, stroke, or cardiovascular death
- Contraindicated in pregnancy: Must not be taken during pregnancy or breastfeeding — use reliable contraception throughout treatment
What Is Rivaroxaban Medical Valley and What Is It Used For?
Quick Answer: Rivaroxaban Medical Valley is a prescription anticoagulant (blood thinner) containing 2.5 mg of rivaroxaban. It works by blocking Factor Xa, a key protein in the blood clotting cascade, and is used alongside aspirin to prevent heart attacks, strokes, and cardiovascular death in adults with established cardiovascular disease.
Rivaroxaban Medical Valley belongs to a class of medicines known as direct oral anticoagulants (DOACs), specifically a direct Factor Xa inhibitor. Unlike older anticoagulants such as warfarin, which act on multiple clotting factors and require regular blood monitoring, rivaroxaban selectively and directly blocks Factor Xa, a pivotal enzyme in the coagulation cascade. By inhibiting Factor Xa, rivaroxaban reduces the generation of thrombin — the enzyme that converts fibrinogen to fibrin and ultimately forms blood clots. This mechanism decreases the tendency of blood to clot without completely eliminating the body's ability to form clots when needed to stop bleeding.
At the 2.5 mg twice-daily dose, Rivaroxaban Medical Valley is specifically indicated for two clinical scenarios. The first is secondary prevention after acute coronary syndrome (ACS), which includes heart attack (myocardial infarction) and unstable angina — a severe type of chest pain indicating inadequate blood flow to the heart. In the landmark ATLAS ACS 2-TIMI 51 trial, adding low-dose rivaroxaban (2.5 mg twice daily) to dual antiplatelet therapy significantly reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke compared to placebo. The 2.5 mg dose also demonstrated a significant reduction in all-cause mortality, including cardiovascular mortality.
The second indication is prevention of atherothrombotic events in adults with coronary artery disease (CAD) or symptomatic peripheral arterial disease (PAD) at high risk of ischemic events. The COMPASS trial showed that rivaroxaban 2.5 mg twice daily combined with aspirin 100 mg once daily reduced the composite of cardiovascular death, stroke, or myocardial infarction by 24% compared to aspirin alone in patients with stable atherosclerotic vascular disease. This dual-pathway inhibition strategy — combining anticoagulation with antiplatelet therapy — addresses both the thrombin-mediated and platelet-mediated pathways that contribute to atherothrombotic events.
It is important to understand that Rivaroxaban Medical Valley at the 2.5 mg dose is not intended for use as a standalone anticoagulant. Higher doses of rivaroxaban (15 mg and 20 mg) are used for different indications, such as the treatment and prevention of deep vein thrombosis and pulmonary embolism, or stroke prevention in atrial fibrillation. The 2.5 mg formulation is specifically designed for cardiovascular protection in combination with antiplatelet therapy.
How Rivaroxaban Works in the Body
The coagulation cascade is a complex series of enzymatic reactions that ultimately leads to the formation of a blood clot. Factor Xa sits at the convergence of the intrinsic and extrinsic coagulation pathways, making it a strategic target for anticoagulation. When Factor Xa is active, it combines with Factor Va to form the prothrombinase complex, which rapidly converts prothrombin (Factor II) to thrombin (Factor IIa). A single molecule of Factor Xa can generate approximately 1,000 molecules of thrombin, amplifying the clotting response enormously.
By selectively inhibiting Factor Xa, rivaroxaban interrupts this amplification process at its source. It inhibits both free Factor Xa and Factor Xa that is already bound within the prothrombinase complex or associated with a clot. Unlike indirect Factor Xa inhibitors such as fondaparinux, rivaroxaban does not require antithrombin III as a cofactor. Its anticoagulant effect is dose-dependent and predictable, which is one of the reasons it does not require routine monitoring of blood clotting parameters.
Rivaroxaban is rapidly absorbed after oral administration, with maximum plasma concentrations achieved within 2 to 4 hours. The 2.5 mg and 10 mg doses have high oral bioavailability (approximately 80–100%) regardless of whether they are taken with food. Higher doses (15 mg and 20 mg) have reduced bioavailability when taken on an empty stomach and must be taken with food, but this does not apply to the low-dose 2.5 mg tablets used for cardiovascular protection. The drug is metabolized primarily by cytochrome P450 3A4 (CYP3A4) and CYP2J2, as well as through CYP-independent mechanisms. About one third is excreted unchanged by the kidneys, one third as inactive metabolites in urine, and one third as inactive metabolites in feces.
The half-life of rivaroxaban is approximately 5 to 9 hours in healthy young adults and 11 to 13 hours in elderly patients. This relatively short half-life means that if a dose is missed, the anticoagulant effect begins to diminish within hours, which is why consistent twice-daily dosing is essential for continuous cardiovascular protection. Conversely, the short half-life is an advantage when the drug needs to be stopped before surgery, as anticoagulation recovers relatively quickly.
What Should You Know Before Taking Rivaroxaban Medical Valley?
Quick Answer: Rivaroxaban Medical Valley is contraindicated in active bleeding, severe liver disease, pregnancy, and breastfeeding. Use caution if you have kidney disease, a history of gastrointestinal problems, or are taking other blood-thinning medications. Always inform your doctor about all medications and health conditions before starting treatment.
Contraindications
There are several situations in which Rivaroxaban Medical Valley must not be taken. Understanding these contraindications is essential for patient safety. Do not take this medicine if:
- You are allergic to rivaroxaban or any of the other ingredients in this medicine (including lactose monohydrate, microcrystalline cellulose, povidone, pregelatinized starch, crospovidone, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide, macrogol 4000, and yellow iron oxide)
- You have active pathological bleeding — any ongoing significant bleeding that requires medical attention
- You have a disease or condition in any organ that increases the risk of serious bleeding, such as gastric or duodenal ulcer, brain or spinal cord injury or bleeding, or recent brain or eye surgery
- You are taking other anticoagulant medicines (e.g., warfarin, dabigatran, apixaban, or heparin), except when transitioning between anticoagulant treatments or when a venous or arterial catheter is being flushed with heparin
- You have acute coronary syndrome and have experienced previous bleeding or blood clot in the brain (stroke)
- You have coronary artery disease or peripheral arterial disease and have had a hemorrhagic stroke, a lacunar stroke (blockage of small deep-brain arteries), or an ischemic non-lacunar stroke within the past month
- You have liver disease that leads to increased bleeding risk (e.g., Child-Pugh class B and C cirrhosis)
- You are pregnant or breastfeeding
Rivaroxaban Medical Valley can cause serious and potentially fatal bleeding. Seek immediate medical attention if you experience signs of bleeding such as: unusual bruising, blood in urine or stool, coughing up blood, prolonged bleeding from cuts, severe headache, dizziness, or weakness. You cannot easily reverse the anticoagulant effect of rivaroxaban at home.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Rivaroxaban Medical Valley. Special caution is required in several circumstances, as the risk of bleeding may be increased. Your doctor will need to weigh the benefits of treatment against the potential risks in these situations:
- Severe kidney disease: Impaired renal function affects how much active drug remains in your body, as rivaroxaban is partially cleared by the kidneys. Your doctor may need to adjust or reconsider your treatment, particularly if your creatinine clearance is below 30 mL/min
- Bleeding disorders: Conditions that affect your blood's ability to clot properly increase the risk of hemorrhage
- Uncontrolled severe hypertension: Very high blood pressure not adequately managed with medication increases the risk of bleeding, particularly intracranial hemorrhage
- Gastrointestinal disease: Conditions such as gastric or intestinal inflammation, esophagitis from gastroesophageal reflux disease (GERD), or tumors located in the stomach, intestines, urogenital, or urinary tract may increase the risk of gastrointestinal bleeding
- Retinopathy: Problems with blood vessels in the back of the eye may increase the risk of ocular bleeding
- Bronchiectasis or pulmonary bleeding history: Widened airways filled with pus, or prior bleeding from the lungs
- Age over 75 years: Elderly patients are at increased risk of bleeding complications
- Body weight under 60 kg: Lower body weight may result in higher drug exposure
- Coronary artery disease with severe symptomatic heart failure
- Prosthetic heart valve: Rivaroxaban has not been studied in patients with mechanical heart valves and should not be used in this population
- Antiphospholipid syndrome: An autoimmune disorder that increases the risk of blood clots — inform your doctor so they can decide if treatment needs to be modified
Rivaroxaban Medical Valley should not be used in combination with prasugrel or ticagrelor — only with aspirin and clopidogrel or ticlopidine. Using rivaroxaban with prasugrel or ticagrelor has not been adequately studied and may significantly increase bleeding risk.
Surgery and Spinal/Epidural Procedures
If you need to undergo surgery, it is critically important to take Rivaroxaban Medical Valley at exactly the times your doctor specifies, both before and after the procedure. Most surgical procedures require that rivaroxaban be stopped at least 24 hours beforehand, though for high-bleeding-risk surgery, a longer interval (48 hours or more) may be recommended. The exact timing depends on the type of surgery, your kidney function, and your bleeding risk profile.
If your surgery involves a spinal or epidural catheter or injection (for anesthesia or pain management), following the precise timing instructions is especially important to minimize the risk of spinal or epidural hematoma, which can lead to long-term or permanent paralysis. Rivaroxaban should be discontinued at least 18 hours before insertion or removal of a spinal/epidural catheter, and the next dose should not be given until at least 6 hours after catheter removal.
Tell your doctor immediately if you experience numbness, weakness in your legs, or problems with your bowels or bladder after spinal or epidural anesthesia, as urgent medical intervention may be necessary.
Pregnancy and Breastfeeding
Rivaroxaban Medical Valley must not be taken during pregnancy or while breastfeeding. The potential risks to the developing fetus and nursing infant have not been adequately characterized, and preclinical animal studies suggest reproductive toxicity, including embryo-fetal developmental effects. Rivaroxaban crosses the placental barrier, and animal data indicate an increased risk of hemorrhagic complications in pregnancy.
Women of childbearing potential must use reliable contraception throughout treatment. If you become pregnant while taking this medicine, contact your doctor immediately for guidance on transitioning to an alternative treatment such as low-molecular-weight heparin, which has an established safety profile in pregnancy. Rivaroxaban is also excreted in breast milk in animal studies, and breastfeeding should be discontinued during treatment.
Children and Adolescents
Rivaroxaban Medical Valley 2.5 mg tablets are not recommended for children or adolescents under 18 years of age. There is insufficient data regarding safety and efficacy in this population for the cardiovascular indications covered by this dose strength. While rivaroxaban has been studied and approved for certain pediatric thromboembolic conditions at different doses, the 2.5 mg cardiovascular protection indication is restricted to adults.
Driving and Operating Machinery
Rivaroxaban Medical Valley may cause dizziness (a common side effect) and fainting (an uncommon side effect). If you experience these symptoms, do not drive, cycle, or operate tools or machinery until the symptoms resolve. You are personally responsible for assessing your fitness to drive or perform tasks requiring alertness.
Important Information About Excipients
Rivaroxaban Medical Valley contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption), contact your doctor before taking this medicine. This medicine also contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially sodium-free and suitable for patients on a low-sodium diet.
How Does Rivaroxaban Medical Valley Interact with Other Drugs?
Quick Answer: Rivaroxaban Medical Valley has significant interactions with antifungal drugs (ketoconazole, itraconazole), HIV protease inhibitors (ritonavir), certain antibiotics (clarithromycin, rifampicin), other anticoagulants, NSAIDs, and some antiepileptics. These can either increase bleeding risk or reduce the effectiveness of rivaroxaban.
Drug interactions with rivaroxaban are clinically significant because they can either increase the anticoagulant effect (raising bleeding risk) or decrease it (reducing protection against blood clots). Rivaroxaban is metabolized primarily through the CYP3A4 enzyme pathway and is a substrate of P-glycoprotein (P-gp). Drugs that strongly inhibit or induce these pathways can substantially alter rivaroxaban blood levels. Always inform your doctor and pharmacist about all medications you are taking, including over-the-counter medicines, herbal supplements, and vitamins.
Major Interactions: Drugs That May Increase Rivaroxaban's Effect (Increased Bleeding Risk)
| Drug / Drug Class | Examples | Mechanism | Clinical Significance |
|---|---|---|---|
| Azole antifungals | Ketoconazole, itraconazole, voriconazole, posaconazole | Strong CYP3A4 and P-gp inhibition | Major — significantly increases rivaroxaban levels |
| HIV protease inhibitors | Ritonavir, lopinavir/ritonavir | Strong CYP3A4 inhibition | Major — significantly increases rivaroxaban levels |
| Macrolide antibiotics | Clarithromycin, erythromycin | Moderate CYP3A4 inhibition | Moderate — closer monitoring may be needed |
| Other anticoagulants | Warfarin, dabigatran, apixaban, enoxaparin, heparin | Additive anticoagulant effect | Major — concomitant use contraindicated (except during transitions) |
| Antiplatelet agents | Clopidogrel, prasugrel, ticagrelor, ticlopidine | Additive antihaemostatic effect | Moderate to Major — prasugrel and ticagrelor not recommended with rivaroxaban |
| NSAIDs | Naproxen, ibuprofen, diclofenac, aspirin (analgesic doses) | Impaired platelet function, GI mucosal damage | Moderate — increased GI bleeding risk |
| SSRIs / SNRIs | Sertraline, fluoxetine, citalopram, venlafaxine, duloxetine | Impaired platelet serotonin uptake | Moderate — increased bleeding tendency |
| Antiarrhythmics | Dronedarone, amiodarone | CYP3A4 and P-gp inhibition | Moderate — limited data available |
Minor Interactions: Drugs That May Decrease Rivaroxaban's Effect (Reduced Protection)
| Drug / Drug Class | Examples | Mechanism | Clinical Significance |
|---|---|---|---|
| Antiepileptics (enzyme inducers) | Phenytoin, carbamazepine, phenobarbital | Strong CYP3A4 induction | Major — may significantly reduce rivaroxaban levels |
| Rifamycin antibiotics | Rifampicin, rifabutin | Strong CYP3A4 and P-gp induction | Major — substantially reduces rivaroxaban levels |
| Herbal products | St. John's Wort (Hypericum perforatum) | CYP3A4 and P-gp induction | Moderate — may reduce rivaroxaban effectiveness |
If your doctor considers that you are at increased risk of developing stomach or intestinal ulcers, preventive treatment with a proton pump inhibitor (PPI) such as omeprazole or pantoprazole may be prescribed alongside rivaroxaban. This is particularly relevant for patients over 65, those with a history of peptic ulcer disease, and those concurrently using aspirin or NSAIDs.
What Is the Correct Dosage of Rivaroxaban Medical Valley?
Quick Answer: The recommended dose is one 2.5 mg tablet taken twice daily (morning and evening), always in combination with aspirin 75–100 mg daily. It can be taken with or without food. Tablets can be crushed and mixed with water or applesauce if swallowing is difficult.
Always take Rivaroxaban Medical Valley exactly as your doctor has told you. The dosing regimen for the 2.5 mg formulation is consistent across its approved indications, but the accompanying antiplatelet therapy may vary depending on the clinical situation. Your doctor will determine how long you should continue treatment based on your individual cardiovascular risk profile, typically ranging from 12 months after acute coronary syndrome to long-term therapy for chronic atherosclerotic disease.
Adults
Standard Dosage
Dose: 2.5 mg twice daily (one tablet in the morning, one tablet in the evening)
Timing: Take at approximately the same times each day, roughly 12 hours apart
With food: Can be taken with or without food
Combination: Always with aspirin (75–100 mg daily), and sometimes clopidogrel or ticlopidine as directed by your doctor
| Indication | Rivaroxaban Dose | Combination Therapy | Treatment Start |
|---|---|---|---|
| After Acute Coronary Syndrome (ACS) | 2.5 mg twice daily | Aspirin 75–100 mg/day ± clopidogrel 75 mg/day or ticlopidine | As soon as ACS is stabilized, earliest 24 hours after hospital admission |
| Coronary Artery Disease (CAD) | 2.5 mg twice daily | Aspirin 75–100 mg/day | As directed by your doctor |
| Peripheral Arterial Disease (PAD) | 2.5 mg twice daily | Aspirin 75–100 mg/day (± short-term clopidogrel after revascularization) | As directed by your doctor |
Renal Impairment
Dose adjustments may be required in patients with reduced kidney function. In patients with mild renal impairment (creatinine clearance 50–80 mL/min), no dose adjustment is necessary. In patients with moderate renal impairment (creatinine clearance 30–49 mL/min), Rivaroxaban Medical Valley 2.5 mg twice daily can be used, but careful monitoring is advised. In patients with severe renal impairment (creatinine clearance 15–29 mL/min), rivaroxaban should be used with caution, and in patients with creatinine clearance below 15 mL/min or on dialysis, rivaroxaban is not recommended.
Hepatic Impairment
Rivaroxaban Medical Valley is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhotic patients classified as Child-Pugh class B and C. No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh class A).
Difficulty Swallowing
If you have difficulty swallowing the tablet whole, speak to your doctor about alternative methods. The tablet can be crushed and mixed with water or applesauce immediately before taking it. Crushed tablets remain stable in water or applesauce for up to 4 hours. If needed, your doctor may also administer the crushed tablet through a nasogastric tube, after which the tube should be flushed with water to ensure the full dose is delivered. When administered via a gastric tube, the tablet should be followed immediately by food.
Children and Adolescents
Rivaroxaban Medical Valley 2.5 mg is not recommended for patients under 18 years of age. The safety and efficacy of this formulation have not been established in pediatric populations for cardiovascular indications.
Elderly Patients
No dose adjustment is required based on age alone. However, elderly patients (particularly those over 75 years) are at increased risk of bleeding, and careful clinical monitoring is recommended. Your doctor will consider your overall risk profile, including kidney function, body weight, fall risk, and concurrent medications, when deciding on treatment. Regular follow-up appointments allow for ongoing assessment of the benefit-risk balance.
Missed Dose
Do not take a double dose to make up for a forgotten dose. Simply take your next dose at the regular scheduled time. Maintaining a consistent dosing schedule is important for optimal cardiovascular protection. If you realize you missed a dose within a few hours of the scheduled time, you may take it then and continue with your normal schedule. If more than 6 hours have passed, skip the missed dose and take the next dose at the usual time.
Overdose
If you take too much Rivaroxaban Medical Valley, or if a child accidentally ingests this medicine, contact your doctor, hospital, or poison control center immediately. Taking too much rivaroxaban increases the risk of bleeding. Activated charcoal may be considered to reduce absorption if ingestion was recent (within 2 hours). For life-threatening or uncontrolled bleeding, andexanet alfa (a specific Factor Xa inhibitor reversal agent) may be used in hospital settings. Prothrombin complex concentrates (PCCs) may also be considered for reversal. Rivaroxaban is not significantly removed by hemodialysis due to high plasma protein binding.
Stopping Treatment
Do not stop taking Rivaroxaban Medical Valley without first talking to your doctor. Discontinuing this medicine without medical supervision may increase the risk of a new heart attack, stroke, or death from cardiovascular causes. If you need to stop treatment for any reason (such as surgery), your doctor will provide specific guidance on when to stop and when to restart. For elective surgery, rivaroxaban is typically stopped 24 to 48 hours before the procedure, depending on bleeding risk and kidney function.
What Are the Side Effects of Rivaroxaban Medical Valley?
Quick Answer: The most common side effects are bleeding (including nosebleeds, gum bleeding, gastrointestinal bleeding, and bruising), anemia, dizziness, headache, low blood pressure, nausea, and skin rash. Serious side effects include intracranial hemorrhage and severe allergic reactions. Seek immediate medical help for signs of major bleeding.
Like all medicines, Rivaroxaban Medical Valley can cause side effects, although not everyone experiences them. As a blood-thinning medication, the most significant risk is bleeding, which can occur in any part of the body. Some bleeding may be hidden (not visible externally) and may manifest as unexplained tiredness, weakness, paleness, dizziness, headache, or swelling. Excessive bleeding can lead to a sudden drop in blood pressure (shock) and can be life-threatening in severe cases.
- Signs of brain bleeding: severe headache, one-sided weakness, vomiting, seizures, decreased consciousness, neck stiffness
- Prolonged or heavy bleeding from any site
- Unexplained symptoms: unusual weakness, tiredness, paleness, dizziness, shortness of breath, chest pain
- Severe skin reactions: widespread rash, blisters, sore mucous membranes (Stevens-Johnson syndrome)
- Severe allergic reactions: swelling of face, lips, tongue, or throat; difficulty breathing; sudden drop in blood pressure
Common
May affect up to 1 in 10 people
- Anemia (decreased red blood cells) causing paleness, weakness, or shortness of breath
- Bleeding in stomach or intestines, urinary or genital tract bleeding (including blood in urine and heavy menstrual bleeding)
- Nosebleed (epistaxis) and gum bleeding
- Bleeding in the eye (including bleeding from the whites of the eyes)
- Bruising and bleeding into tissues or body cavities (hematoma)
- Coughing up blood (hemoptysis)
- Bleeding from skin or under the skin
- Post-procedural hemorrhage, oozing from surgical wound
- Swelling or pain in the limbs
- Impaired kidney function (seen in laboratory tests)
- Fever
- Stomach pain, digestive discomfort, nausea, vomiting, constipation, diarrhea
- Low blood pressure (may cause dizziness or fainting on standing)
- Decreased general strength and energy (weakness, fatigue), headache, dizziness
- Skin rash, itching
- Elevated liver enzymes (seen in blood tests)
Uncommon
May affect up to 1 in 100 people
- Bleeding in the brain or inside the skull (intracranial hemorrhage)
- Bleeding into a joint causing pain and swelling (hemarthrosis)
- Thrombocytopenia (low platelet count)
- Allergic reactions including allergic skin reactions
- Impaired liver function (seen in laboratory tests)
- Elevated bilirubin, pancreatic or liver enzyme levels
- Fainting (syncope)
- Feeling unwell (malaise)
- Increased heart rate (tachycardia)
- Dry mouth
- Hives (urticaria)
Rare
May affect up to 1 in 1,000 people
- Bleeding into a muscle
- Cholestasis (reduced bile flow), hepatitis including hepatocellular damage
- Jaundice (yellowing of skin and eyes)
- Localized swelling
- Pseudoaneurysm (groin hematoma as a complication of cardiac catheterization)
Very Rare
May affect up to 1 in 10,000 people
- Eosinophilic pneumonia (accumulation of eosinophils causing lung inflammation)
- Anaphylactic reactions including anaphylactic shock
- Stevens-Johnson syndrome / toxic epidermal necrolysis (severe skin reactions)
- DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms)
Frequency Not Known
Cannot be estimated from available data
- Kidney failure after severe bleeding
- Renal bleeding, sometimes with blood in urine, leading to kidney dysfunction (anticoagulant-related nephropathy)
- Compartment syndrome after bleeding (increased pressure in muscles of limbs causing pain, swelling, numbness, or paralysis)
Reporting Suspected Side Effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through your national reporting system (e.g., FDA MedWatch in the United States, MHRA Yellow Card in the United Kingdom, EMA EudraVigilance in the European Union). By reporting side effects, you help provide more information on the safety of this medicine for future patients.
How Should You Store Rivaroxaban Medical Valley?
Quick Answer: Store at room temperature, out of the reach of children, and use before the expiration date on the packaging. No special storage conditions required. Crushed tablets mixed with water or applesauce are stable for up to 4 hours.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and on each blister after "EXP." The expiry date refers to the last day of the stated month. There are no special storage requirements for intact tablets — they can be stored at normal room temperature, typically below 30°C (86°F). Protect from excessive moisture, although special moisture precautions are not required when tablets are kept in their original blister packaging.
If you have crushed the tablet and mixed it with water or applesauce, the mixture remains stable for up to 4 hours. After that time, any unused mixture should be discarded. Do not prepare the suspension in advance.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment. Many countries have specific pharmacy take-back programs for unused medications, and rivaroxaban should be returned to these programs rather than flushed down toilets or discarded in regular trash.
What Does Rivaroxaban Medical Valley Contain?
Quick Answer: Each film-coated tablet contains 2.5 mg of rivaroxaban as the active ingredient. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, and various excipients. The tablets are light yellow, round, biconvex, approximately 6 mm in diameter.
Active Ingredient
Each film-coated tablet contains 2.5 mg rivaroxaban. Rivaroxaban is a white to yellowish crystalline substance with low water solubility. The chemical name is 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide, with a molecular formula of C19H18ClN3O5S and a molecular weight of 435.88 g/mol.
Inactive Ingredients (Excipients)
Tablet core: Microcrystalline cellulose, lactose monohydrate, povidone, pregelatinized starch, crospovidone, sodium lauryl sulfate, magnesium stearate.
Film coating: Hypromellose (E464), titanium dioxide (E171), macrogol 4000 (E1521), yellow iron oxide (E172).
These excipients are included to ensure the proper formation, stability, dissolution, and palatability of the tablet. They are all widely used pharmaceutical ingredients with established safety profiles, though the lactose content (as noted above) may be relevant for patients with specific intolerances.
Appearance and Packaging
Rivaroxaban Medical Valley 2.5 mg tablets are light yellow, round, biconvex film-coated tablets with a diameter of approximately 6 mm. They are supplied in aluminium/PVC-PE-PVDC blisters or unit-dose blisters in pack sizes ranging from 10 to 196 tablets. Not all pack sizes may be marketed in every country — availability depends on local regulatory approval and market demand.
Marketing Authorization Holder: Medical Valley.
Active substance: Rivaroxaban (2.5 mg per film-coated tablet).
Regulatory status: Approved as a generic equivalent of the reference product Xarelto® 2.5 mg (Bayer AG). Generic medicines meet the same strict regulatory standards for quality, safety, and efficacy as their branded counterparts.
Frequently Asked Questions About Rivaroxaban Medical Valley
Medical References
- European Medicines Agency (EMA). Rivaroxaban — Summary of Product Characteristics. Available at: www.ema.europa.eu. Accessed December 2025.
- Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in Patients with a Recent Acute Coronary Syndrome (ATLAS ACS 2-TIMI 51). N Engl J Med. 2012;366(1):9–19. doi:10.1056/NEJMoa1112277
- Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease (COMPASS). N Engl J Med. 2017;377(14):1319–1330. doi:10.1056/NEJMoa1709118
- Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation. Eur Heart J. 2021;42(5):373–498.
- World Health Organization. WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: WHO; 2023.
- Steffel J, Collins R, Antz M, et al. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. Europace. 2021;23(10):1612–1676.
- Connolly SJ, Eikelboom JW, Bosch J, et al. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial (COMPASS). Lancet. 2018;391(10117):205–218.
- British National Formulary (BNF). Rivaroxaban. National Institute for Health and Care Excellence. Available at: bnf.nice.org.uk. Accessed December 2025.
- U.S. Food and Drug Administration (FDA). Xarelto (rivaroxaban) Prescribing Information. Available at: www.accessdata.fda.gov. Accessed December 2025.
- Byon W, Garonzik S, Boyd RA, Frost CE. Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review. Clin Pharmacokinet. 2019;58(10):1265–1279.
Editorial Team
iMedic Medical Editorial Team
Specialists in Cardiology & Clinical Pharmacology
iMedic Medical Review Board
Independent medical review according to international guidelines (EMA, ESC, WHO)
All pharmaceutical content on iMedic is written and reviewed by licensed specialist physicians. Our editorial process follows international medical guidelines and the GRADE evidence framework. We have no commercial funding and accept no pharmaceutical advertising. Learn more about our medical team.