Rivaroxaban 2.5 mg Tablet, Film Coated, 180-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Factor Xa Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Rivaroxaban is used to: prevent and treat deep vein thrombosis (DVT; a blood clot) and pulmonary embolism (PE; a blood clot in the lung). lower the risk of a heart attack, stroke, or death in people with coronary artery disease (narrowing of the blood vessels that bring blood to the heart) or peripheral arterial disease (poor blood flow to the arms and legs). Rivaroxaban is in a class of medications called factor Xa inhibitors. It works by blocking a natural substance that helps blood clots to form.
Read the full MedlinePlus article ↗- Yes, rivaroxaban is a blood thinner, but it covers a pretty wide range of conditions. It's used to treat blood clots in the legs (DVT) and lungs (pulmonary embolism), prevent those...
- What exactly is rivaroxaban used for — is it just a blood thinner?
- It depends on the strength you've been prescribed. Certain higher-strength tablets need to be taken with food — food helps your body absorb enough of the medication. Lower-strength...
- Do I need to take rivaroxaban with food?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.656 | $118.08 / 180 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $4.05 | $728.60 / 180 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rivaroxaban 2.5 mg 33342-0488-09 | Macleods | 60 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 43598-0981-18 | Dr.Reddy's | 180 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 50228-0513-18 | ScieGen | 180 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 51672-4228-04 | Sun | 60 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 59651-0849-18 | Aurobindo | 180 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 68180-0709-06 | Lupin | 30 tablets | $0.656 | AB | Availability likely | — |
| rivaroxaban 2.5 mg 71921-0405-06 | Florida | 60 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mg 72205-0416-02 | Novadoz | 10 tablets | $0.656 | AB | Availability likely | — |
| Rivaroxaban 2.5 mgthis 76282-0774-18 | Exelan | 180 tablets | $0.656 | AB | Availability likely | — |
| Xarelto 2.5 mg 50458-0577-10 | Janssen | 10 tablets | $9.779 | AB | Availability likely | +1391% |
| Rivaroxaban 2.5 mg 14445-0147-10 | Indoco | 10 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 31722-0496-18 | Camber | 180 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 46708-0683-10 | Alembic | 10 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 60505-6256-05 | Apotex | 500 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 62332-0683-10 | Alembic | 10 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 72603-0890-01 | NorthStar | 60 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 72865-0321-18 | XLCare | 180 tablets | — | AB | FDA listed | — |
| Rivaroxaban 2.5 mg 42571-0345-05 | Micro | 500 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 76282-0774-18 You're viewing this | 180 TABLET, FILM COATED in 1 BOTTLE (76282-774-18) | $0.6560 / ea | $118.08 | 2025-08-04 | Active |
| 76282-0774-60 | 60 TABLET, FILM COATED in 1 BOTTLE (76282-774-60) | $0.6560 / ea | $39.36 | 2025-08-04 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.6560 NADAC).
Pack size FAQ
What quantity is in NDC 76282-0774-18?
What is the difference between NDC 76282-0774-18 and NDC 76282-0774-60?
What NDC number is used to bill for this package of Rivaroxaban 2.5 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: (A) PREMATURE DISCONTINUATION OF RIVAROXABAN TABLETS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of Rivaroxaban Tablets increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including rivaroxaban Tablets, increases the risk of thrombotic events. If anticoagulation with Rivaroxaban Tablets is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration ( 2.3 , 2.4 ), Warnings and Precautions ( 5.1 ), and Clinical Studies ( 14.1 )].
B. Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with Rivaroxaban Tablets who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.
Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulantsa history of traumatic or repeated epidural or spinal puncturesa history of spinal deformity or spinal surgeryoptimal timing between the administration of rivaroxaban and neuraxial procedures is not known [see Warnings and Precautions ( 5.2 , 5.3 ) and Adverse Reactions ( 6.2 )] Monitor patients frequently for signs and symptoms of neurological impairment.
If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions ( 5.3 )] Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions ( 5.3 )] WARNING: (A) PREMATURE DISCONTINUATION OF RIVAROXABAN TABLETS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) Premature discontinuation of Rivaroxaban Tablets increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including Rivaroxaban Tablets, increases the risk of thrombotic events.
To reduce this risk, consider coverage with another anticoagulant if Rivaroxaban Tablets is discontinued for a reason other than pathological bleeding or completion of a course of therapy. ( 2.2 , 2.3 , 5.1 , 14.1 ) (B) Spinal/epiduralhematoma Epidural or spinal hematomas have occurred in patients treated with Rivaroxaban Tablets who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.
( 5.2 , 5.3 , 6.2 ) Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated. ( 5.3 )
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Rivaroxaban Tablets is a factor Xa inhibitor indicated: to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 )
1.7Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban Tablets, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease.
1.8Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD Rivaroxaban Tablets, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION CAD or PAD: 2.5 mg orally twice daily with or without food, in combination with aspirin (75 mg to 100 mg) once daily ( 2.1 )
2.1Recommended Dosage in Adults Table 1: Recommended Dosage in Adults Indication Renal Considerations* Dosage Food/Timing† Reduction of Risk of Major Cardiovascular Events (CV Death, MI, and Stroke) in CAD No dose adjustment needed based on CrCl 2.5 mg twice daily, plus aspirin (75-100 mg) once daily Take with or without food Reduction of Risk of Major Thrombotic Vascular Events in PAD, Including Patients after Lower Extremity Revascularization due to Symptomatic PAD No dose adjustment needed based on CrCl 2.5 mg twice daily, plus aspirin (75-100 mg) once daily.
When starting therapy after a successful lower extremity revascularization procedure, initiate once hemostasis has been established. Take with or without food * Calculate CrCl based on actual weight. [See Warnings and Precautions ( 5.4 ) and Use in Specific Populations ( 8.6 )] † See Clinical Pharmacology ( 12.3 )
2.2Recommended Dosage in Pediatric Patients Rivaroxaban 2.5 mg tablets are not recommended for use in pediatric patients [ see Use in Specific Populations ( 8.4 ) ]
2.3Switching to and from Rivaroxaban Tablets Switching from Warfarin to Rivaroxaban Tablets – When switching patients from warfarin to Rivaroxaban Tablets, discontinue warfarin and start Rivaroxaban Tablets as soon as the International Normalized Ratio (INR) is below 3.0 in adults and below 2.5 in pediatric patients to avoid periods of inadequate anticoagulation. Switching from Rivaroxaban Tablets to Warfarin – Adults: No clinical trial data are available to guide converting patients from Rivaroxaban Tablets to warfarin.
Rivaroxaban Tablets affects INR, so INR measurements made during coadministration with warfarin may not be useful for determining the appropriate dose of warfarin. One approach is to discontinue Rivaroxaban Tablets and begin both a parenteral anticoagulant and warfarin at the time the next dose of Rivaroxaban Tablets would have been taken. Once Rivaroxaban Tablets are discontinued, INR testing may be done reliably 24 hours after the last dose.
Switching from Rivaroxaban Tablets to Anticoagulants other than Warfarin – Patients currently taking Rivaroxaban Tablets and transitioning to an anticoagulant with rapid onset, discontinue Rivaroxaban Tablets and give the first dose of the other anticoagulant (oral or parenteral) at the time that the next Rivaroxaban Tablets dose would have been taken [see Drug Interactions ( 7.4 )]. Switching from Anticoagulants other than Warfarin to Rivaroxaban Tablets – Patients currently receiving an anticoagulant other than warfarin, start Rivaroxaban Tablets 0 hours to 2 hours prior to the next scheduled administration of the drug (e.g., low molecular weight heparin or nonwarfarin oral anticoagulant) and omit administration of the other anticoagulant.
For unfractionated heparin being administered by continuous infusion, stop the infusion and start Rivaroxaban Tablets at the same time.
2.4Discontinuation for Surgery and other Interventions If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, Rivaroxaban Tablets should be stopped at least 24 hours before the procedure to reduce the risk of bleeding [see Warnings and Precautions ( 5.2 )]. In deciding whether a procedure should be delayed until 24 hours after the last dose of Rivaroxaban Tablets, the increased risk of bleeding should be weighed against the urgency of intervention. Rivaroxaban Tablets should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established, noting that the time to onset of therapeutic effect is short [see Warnings and Precautions ( 5.1 )].
If oral medication cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant.
2.5Missed Dose Adults For patients receiving 2.5 mg twice daily: if…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS • 2.5 mg tablets: Beige, round, film coated tablets debossed with ‘513’ on one side and plain on the other side. • Tablets: 2.5 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Rivaroxaban tablets are contraindicated in patients with: active pathological bleeding [see Warnings and Precautions ( 5.2 )] severe hypersensitivity reaction to Rivaroxaban Tablets (e.g., anaphylactic reactions) [see Adverse Reactions ( 6.2 )] Active pathological bleeding ( 4 ) Severe hypersensitivity reaction to Rivaroxaban Tablets ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Risk of bleeding: Rivaroxaban Tablets can cause serious and fatal bleeding. An agent to reverse the activity of rivaroxaban is available. ( 5.2 ) Pregnancy-related hemorrhage: Use Rivaroxaban Tablets with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery.
( 5.7 , 8.1 ) Prosthetic heart valves: Rivaroxaban Tablets use not recommended. ( 5.8 ) Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: Rivaroxaban Tablets use not recommended. ( 5.10 )
5.1Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including Rivaroxaban Tablets, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Rivaroxaban Tablets to warfarin in clinical trials in atrial fibrillation patients. If Rivaroxaban Tablets are discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration ( 2.3 , 2.4 ) and Clinical Studies ( 14.1 )].
5.2Risk of Bleeding Rivaroxaban Tablets increases the risk of bleeding, including in any organ, and can cause serious or fatal bleeding. In deciding whether to prescribe Rivaroxaban Tablets to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.
Discontinue Rivaroxaban Tablets in patients with active pathological hemorrhage. The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 years to 45 years. Concomitant use of other drugs that impair hemostasis increases the risk of bleeding.
These include aspirin, P2Y12 platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions ( 7.4) ] , selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors. Concomitant use of drugs that are known combined P-gp and strong CYP3A inhibitors increases rivaroxaban exposure and may increase bleeding risk [see Drug Interactions ( 7.2 )]. Reversal of Anticoagulant Effect An agent to reverse the anti-factor Xa activity of rivaroxaban is available.
Because of high plasma protein binding, rivaroxaban is not dialyzable [see Clinical Pharmacology ( 12.3 )]. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies.
Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.
5.3Spinal/Epidural Anesthesia or Puncture When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in longterm or permanent paralysis [see Boxed Warning]. To reduce the potential risk of bleeding associated with the concurrent use of Rivaroxaban Tablets and epidural or spinal anesthesia/ analgesia or spinal puncture, consider the pharmacokinetic profile of Rivaroxaban Tablets [see Clinical Pharmacology ( 12.3 )].
Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of Rivaroxaban Tablets is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known. An indwelling epidural or intrathecal catheter should n…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed in other sections of the labeling: Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation [see Boxed Warning and Warnings and Precautions ( 5.1 )] Bleeding Risk [see Warnings and Precautions ( 5.2 , 5.4 , 5.5 , 5.6 , 5.7 )] Spinal/Epidural Hematoma [see Boxed Warning and Warnings and Precautions ( 5.3 )] The most common adverse reaction (>5%) in adult patients was bleeding. ( 6.1 ) The most common adverse reactions (>10%) in pediatric patients were bleeding, cough, vomiting, and gastro enteritis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at (1-855-724-3436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During clinical development for the approved indications, 34,947 adult patients were exposed to Rivaroxaban Tablets. Hemorrhage The most common adverse reactions with Rivaroxaban Tablets were bleeding complications [see Warnings and Precautions ( 5.2 )].
Reduction of Risk of Major Cardiovascular Events in Patients with CAD In the COMPASS trial overall, the most frequent adverse reactions associated with permanent drug discontinuation were bleeding events, with incidence rates of 2.7% for Rivaroxaban Tablets 2.5 mg twice daily vs. 1.2% for placebo on background therapy for all patients with aspirin 100 mg once daily. The incidences of important bleeding events in the CAD and PAD populations in COMPASS were similar.
Table 10 shows the number of patients experiencing various types of major bleeding events in the COMPASS trial. Table 10: Major Bleeding Events in COMPASS - On Treatment Plus 2 Days* Parameter Rivaroxaban † N=9134 n(%/year) Placebo† N=9107 n (%/year) Rivaroxabanvs. Placebo HR(95%CI) Modified ISTH Major Bleeding‡ 263 (1.6) 144 (0.9) 1.8 (1.5, 2.3) - Fatal bleeding event Intracranial hemorrhage (ICH) Non-intracranial 12 (<0.1) 6 (<0.1) 6 (<0.1) 8 (<0.1) 3 (<0.1) 5 (<0.1) 1.5 (0.6, 3.7) 2.0 (0.5, 8.0) 1.2 (0.4, 4.0) - Symptomatic bleeding in critical organ (non-fatal) - ICH (fatal and non-fatal) Hemorrhagic Stroke Other ICH 58 (0.3) 23 (0.1) 18 (0.1) 6 (<0.1) 43 (0.3) 21 (0.1) 13 (<0.1) 9 (<0.1) 1.4 (0.9, 2.0) 1.1 (0.6, 2.0) 1.4 (0.7, 2.8) 0.7 (0.2, 1.9) - Bleeding into the surgical site requiring reoperation (non-fatal, not in critical organ) 7 (<0.1) 6 (<0.1) 1.2 (0.4, 3.5) - Bleeding leading to hospitalization (non-fatal, not in critical organ, not requiring reoperation) 188 (1.1) 91 (0.5) 2.1 (1.6, 2.7) Major GI bleeding 117 (0.7) 49 (0.3) 2.4 (1.7, 3.4) * Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories.
These events occurred during treatment or within 2 days of stopping treatment in the safety analysis set in COMPASS patients. † Treatment schedule: Rivaroxaban Tablets 2.5 mg twice daily or placebo. All patients received background therapy with aspirin 100 mg once daily. ‡ Defined as i) fatal bleeding, or ii) symptomatic bleeding in a critical area or organ, such as intraarticular, intramuscular with compartment syndrome, intraspinal, intracranial, intraocular, respiratory, pericardial, liver, pancreas, retroperitoneal, adrenal gland or kidney; or iii) bleeding into the surgical site requiring reoperation, or iv) bleeding leading to hospitalization.
CI: confidence interval; HR: hazard ratio; ISTH: International Society on Thrombosis and Hemostasis Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD The incidence of premature perm…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Avoid combined P-gp and strong CYP3A inhibitors and inducers ( 7.2 , 7.3 ) Anticoagulants: Avoid concomitant use ( 7.4 )
7.1General Inhibition and Induction Properties Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters. Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events.
7.2Drugs that Inhibit Cytochrome P450 3A Enzymes and Drug Transport Systems Interaction with Combined P-gp and Strong CYP3A Inhibitors Avoid concomitant administration of Rivaroxaban Tablets with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir) [see Warnings and Precautions ( 5.6 ) and Clinical Pharmacology ( 12.3 )]. Although clarithromycin is a combined P-gp and strong CYP3A inhibitor, pharmacokinetic data suggests that no precautions are necessary with concomitant administration with Rivaroxaban Tablets as the change in exposure is unlikely to affect the bleeding risk [see Clinical Pharmacology ( 12.3 )].
Interaction with Combined P-gp and Moderate CYP3A Inhibitors in Patients with Renal Impairment Rivaroxaban Tablets should not be used in patients with CrCl 15 to <80 mL/min who are receiving concomitant combined P-gp and moderate CYP3A inhibitors (e.g., erythromycin) unless the potential benefit justifies the potential risk [see Warnings and Precautions ( 5.4 ) and Clinical Pharmacology ( 12.3 )].
7.3Drugs that Induce Cytochrome P450 3A Enzymes and Drug Transport Systems Avoid concomitant use of Rivaroxaban Tablets with drugs that are combined P-gp and strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s wort) [see Warnings and Precautions ( 5.6 ) and Clinical Pharmacology ( 12.3 )].
7.4Anticoagulants and NSAIDs/Aspirin Coadministration of enoxaparin, warfarin, aspirin, clopidogrel and chronic NSAID use may increase the risk of bleeding [see Clinical Pharmacology ( 12.3 )]. Avoid concurrent use of Rivaroxaban Tablets with other anticoagulants due to increased bleeding risk unless benefit outweighs risk. Promptly evaluate any signs or symptoms of blood loss if patients are treated concomitantly with aspirin, other platelet aggregation inhibitors, or NSAIDs [see Warnings and Precautions ( 5.2 )].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Renal impairment: Avoid or adjust dose ( 8.6 ) Hepatic impairment: Avoid use in Child-Pugh B and C hepatic impairment or hepatic disease associated with coagulopathy ( 8.7 )
8.1Pregnancy Risk Summary The limited available data on Rivaroxaban Tablets in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use Rivaroxaban Tablets with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of Rivaroxaban Tablets cannot be reliably monitored with standard laboratory testing.
Consider the benefits and risks of Rivaroxaban Tablets for the mother and possible risks to the fetus when prescribing Rivaroxaban Tablets to a pregnant woman [see Warnings and Precautions ( 5.2 , 5.7 )]. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 % to 4% and 15 % to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnancy is a risk factor for venous thromboembolism and that risk is increased in women with inherited or acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications including pre-eclampsia.
Maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption and early and late pregnancy loss. Fetal/Neonatal Adverse Reactions Based on the pharmacologic activity of Factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate. Labor or Delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding and this risk may be increased during labor or delivery [see Warnings and Precautions ( 5.7 )].
The risk of bleeding should be balanced with the risk of thrombotic events when considering the use of Rivaroxaban Tablets in this setting. Data Human Data There are no adequate or well-controlled studies of Rivaroxaban Tablets in pregnant women, and dosing for pregnant women has not been established. Post-marketing experience is currently insufficient to determine a rivaroxaban-associ- ated risk for major birth defects or miscarriage.
In an in vitro placenta perfusion model, unbound rivaroxaban was rapidly transferred across the human placenta. Animal Data Rivaroxaban crosses the placenta in animals. Rivaroxaban increased fetal toxicity (increased resorptions, decreased number of live fetuses, and decreased fetal body weight) when pregnant rabbits were given oral doses of ≥10 mg/kg rivaroxaban during the period of organogenesis.
This dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the highest recommended human dose of 20 mg/day. Fetal body weights decreased when pregnant rats were given oral doses of 120 mg/kg during the period of organogenesis. This dose corresponds to about 14 times the human exposure of unbound drug.
In rats, peripartal maternal bleeding and maternal and fetal death occurred at the rivaroxaban dose of 40 mg/kg (about 6 times maximum human exposure of the unbound drug at the human dose of 20 mg/day)
8.2Lactation Risk Summary Rivaroxaban has been detected in human milk. There are insufficient data to determine the effects of rivaroxaban on the breastfed child or on milk production. Rivaroxaban and/or its metabolites were present in the milk of rats.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Rivaroxaban Tablets and any potential adverse effects on the breastfed infant from Rivaroxaban Tablets or from the underlying mater…
🆘 Overdosage ▾
10 OVERDOSAGE Overdose of Rivaroxaban Tablets may lead to hemorrhage. Discontinue Rivaroxaban Tablets and initiate appropriate therapy if bleeding complications associated with overdosage occur. Rivaroxaban systemic exposure is not further increased at single doses >50 mg due to limited absorption.
The use of activated charcoal to reduce absorption in case of Rivaroxaban Tablets overdose may be considered. Due to the high plasma protein binding, rivaroxaban is not dialyzable [see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 )]. Partial reversal of laboratory anticoagulation parameters may be achieved with use of plasma products.
An agent to reverse the anti-factor Xa activity of rivaroxaban is available.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Rivaroxaban is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.
12.2Pharmacodynamics Rivaroxaban produces dose-dependent inhibition of FXa activity. Clotting tests, such as prothrombin time (PT), activated partial thromboplastin time (aPTT) and HepTest ® , are also prolonged dose-dependently. In children treated with rivaroxaban, the correlation between anti-factor Xa to plasma concentrations is linear with a slope close to 1.
Monitoring for anticoagulation effect of rivaroxaban using anti-FXa activity or a clotting test is not recommended. Specific Populations Renal Impairment The relationship between systemic exposure and pharmacodynamic activity of rivaroxaban was altered in adult subjects with renal impairment relative to healthy control subjects [see Use in Specific Populations ( 8.6 )]. Table 18: Percentage Increase in Rivaroxaban PK and PD Measures in Adult Subjects with Renal Impairment Relative to Healthy Subjects from Clinical Pharmacology Studies Measure Parameter Creatinine Clearance (mL/min) 50-79 30-49 15-29 ESRD (on dialysis)* ESRD (post-dialysis)* Exposure AUC 44 52 64 47 56 FXa Inhibition AUEC 50 86 100 49 33 PT Prolongation AUEC 33 116 144 112 158 *Separate stand-alone study.
PT = Prothrombin time; FXa = Coagulation factor Xa; AUC = Area under the plasma concentration-time curve; AUEC = Area under the effect-time curve Hepatic Impairment Anti-Factor Xa activity was similar in adult subjects with normal hepatic function and in mild hepatic impairment (Child-Pugh A class). There is no clear understanding of the impact of hepatic impairment beyond this degree on the coagulation cascade and its relationship to efficacy and safety.
12.3Pharmacokinetics Absorption The absolute bioavailability of rivaroxaban is dose-dependent. For the 2.5 mg and 10 mg dose, it is estimated to be 80% to 100% and is not affected by food. Rivaroxaban 2.5 mg tablets and 10 mg tablets can be taken with or without food.
Rivaroxaban Tablets 20 mg administered in the fasted state has an absolute bioavailability of approximately 66%. Coadministration of Rivaroxaban Tablets with food increases the bioavailability of the 20 mg dose (mean AUC and Cmax increasing by 39% and 76% respectively with food). Rivaroxaban 15 mg tablets and 20 mg tablets should be taken with food [see Dosage and Administration ( 2.1 )].
The maximum concentrations (C max ) of rivaroxaban appear 2 hours to 4 hours after tablet intake. The pharmacokinetics of rivaroxaban were not affected by drugs altering gastric pH. Coadministration of Rivaroxaban Tablets (30 mg single dose) with the H2-receptor antagonist ranitidine (150 mg twice daily), the antacid aluminum hydroxide/magnesium hydroxide (10 mL) or Rivaroxaban Tablets (20 mg single dose) with the PPI omeprazole (40 mg once daily) did not show an effect on the bioavailability and exposure of rivaroxaban (see Figure 3) .
Absorption of rivaroxaban is dependent on the site of drug release in the GI tract. A 29% and 56% decrease in AUC and Cmax compared to tablet was reported when rivaroxaban granulate is released in the proximal small intestine. Exposure is further reduced when drug is released in the distal small intestine, or ascending colon.
Avoid administration of rivaroxaban distal to the stomach which can result in reduced absorption and related drug exposure. In a study with 44 healthy subjects, both mean AUC and C max values for 20 mg rivaroxaban administered orally as a crushed tablet mixed in applesauce were comparable to that after the whole tablet. However, for the crushed tablet suspended in water and administered via an NG tube followed by a liquid meal, only mean AU…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Rivaroxaban Tablets USP, 2.5 mg available in the packages listed below: 2.5 mg tablets: Beige, round, film coated tablets debossed with ‘513’ on one side and plain on the other side. The tablets are supplied in the packages listed: NDC 76282-774-60 Bottle containing 60 tablets NDC 76282-774-18 Bottle containing 180 tablets Store at room temperature between 20 o C to 25 o C (68 o F to 77 o F); excursions permitted between 15 o C to 30 o C (59 o F to 86 o F) [see USP Controlled Room Temperature].
Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in Rivaroxaban Tablets, USP with the chemical name 5-Chloro-N-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl] thiophene-2-carboxamide. The molecular formula of rivaroxaban is C 19 H 18 C 1 N 3 O 5 S and the molecular weight is 435.88. The structural formula is: Rivaroxaban is a pure (S)-enantiomer.
It is an odorless, non-hygroscopic, white to off-white powder. Freely soluble in dimethyl sulphoxide, dimethyl formamide, Slightly soluble in Dichloromethane, Very slightly soluble in acetone, and methanol and practically insoluble in water, anhydrous ethanol and heptane. Each Rivaroxaban Tablets, USP contains 2.5 mg,of rivaroxaban.
The inactive ingredients of Rivaroxaban Tablets, USP are: Anhydrous Lactose NF, Croscarmellose Sodium NF, Hypromellose USP, Magnesium Stearate NF, and Sodium Lauryl Sulfate NF. Additionally, the film coating mixture for Rivaroxaban 2.5 mg tablets is Opadry II Beige, and contains: Polyethylene Glycol, Polyvinyl Alcohol, Red Iron Oxide, Talc, Titanium Dioxide, and Yellow Iron Oxide. Rivaroxaban Structure.jpg
💬 Medication Guide ▾
Dispense the Medication Guide available at: https://sciegenpharm.com/medication-guide/ MEDICATION GUIDE Rivaroxaban (RIV-a-ROX-a-ban) tablets What is the most important information I should know about Rivaroxaban Tablets? Rivaroxaban Tablets may cause serious side effects, including: Increased risk of blood clots if you stop taking Rivaroxaban Tablets. People with atrial fibrillation (a type of irregular heart beat) that is not caused by a heart valve problem (non-valvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body.
Rivaroxaban lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking Rivaroxaban, you may have increased risk of forming a clot in your blood. Do not stop taking Rivaroxaban without talking to the doctor who prescribes it for you.
Stopping Rivaroxaban increases your risk of having a stroke. If you have to stop taking Rivaroxaban, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. Increased risk of bleeding .
Rivaroxabancan cause bleeding which can be serious and may lead to death. This is because Rivaroxaban is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with Rivaroxaban you are likely to bruise more easily, and it may take longer for bleeding to stop.
You may have a higher risk of bleeding if you take Rivaroxaban and have certain other medical problems. You may have a higher risk of bleeding if you take Rivaroxaban Tablets and take other medicines that increase your risk of bleeding, including: aspirin or aspirin containing products long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) warfarin sodium (Coumadin®, Jantoven®) any medicine that contains heparin clopidogrel (Plavix®) selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines.
Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time, such as: nose bleeds that happen often unusual bleeding from the gums menstrual bleeding that is heavier than normal or vaginal bleeding bleeding that is severe or you cannot control red, pink or brown urine bright red or black stools (looks like tar) cough up blood or blood clots vomit blood or your vomit looks like "coffee grounds" headaches, feeling dizzy or weak pain, swelling, or new drainage at wound sites left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder or diffuse abdominal discomfort (these may be symptoms of rupture of the spleen) Spinal or epidural blood clots (hematoma).
People who take a blood thinner medicine (anticoagulant) like Rivaroxaban Tablets, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: a thin tube called an epidural catheter is placed in your back to give you certain medicine you take NSAIDs or a medicine to prevent blood from clotting you have a history of difficult or repeated epidural or spinal punctures you have a history of problems with your spine or have had surgery on your spine If you take Rivaroxaban Tablets and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots.
Tell your doctor right away if you have: back pain tingling numbness muscle weakness (especially in your legs and feet) loss of control of the bowels or bladder (incontinence) Rivarox…