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Xarelto- Rivaroxaban Tablet, Film Coated 20 Mg (90 Tablets)

  • Manufacturer Name : J-O-M PHARM SERVICES
  • MFG # : 50458057990
  • NDC : 50458057990
  • Distributor Name : AmeriSource Bergen
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Description

Indications and Usage:

1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation

XARELTO is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1)].

1.2 Treatment of Deep Vein Thrombosis

XARELTO is indicated for the treatment of deep vein thrombosis (DVT).

1.3 Treatment of Pulmonary Embolism

XARELTO is indicated for the treatment of pulmonary embolism (PE).

1.4 Reduction in the Risk of Recurrence of Deep Vein Thrombosis and/or Pulmonary Embolism

XARELTO is indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.

1.5 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery.

1.6 Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding

XARELTO is indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding [see Warnings and Precautions (5.2) and Clinical Studies (14.5)] .

1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD)

XARELTO, 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.

1.8 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

XARELTO, 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.

1.9 Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients

XARELTO is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment.

1.10 Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure

XARELTO is indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.

Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind -
DESI2 Drug Ind NR
Drug Category -
Drug Category S
Drug Type Code 1
Drug Type Code S
FDA Approval Date 11/08/2011
FDA Approval Date 11/04/2011
FDA Therap Equiv NR
FDA Therap Equiv TAB
HCPCS -
HCPCS -
Market Entry Date 11/08/2011
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date -
Unit 1
Unit TAB
Units Per Pkg 1
Units Per Pkg 11/04/2011
Active Ingredients 12873 rivaroxaban 366789028
Active Ingredients 12873 rivaroxaban 366789028
AHFS Class 20120414 DIRECT FACTOR XA INHIBITORS
AHFS Class 20120414 DIRECT FACTOR XA INHIBITORS
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 68119 rivaroxaban ORAL TABLET 20 MG
Gen Code and Des 68119 rivaroxaban ORAL TABLET 20 MG
Inactive Ingredients 2432 lactose 64044515
Inactive Ingredients 2432 lactose 64044515
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 20MG
Strength 20MG
Common Brand Name COMMON BRAND NAME(S): Xarelto
Common Brand Name COMMON BRAND NAME(S): Xarelto
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: mifepristone, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/enoxaparin), certain antidepressants (including SSRIs such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine). Other medications can affect the removal of rivaroxaban from your body, which may affect how rivaroxaban works. Examples include cobicistat, conivaptan, dronedarone, ritonavir, certain azole antifungals (itraconazole, ketoconazole, posaconazole), HIV protease inhibitors (such as lopinavir), rifamycins (such as rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others. Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: mifepristone, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/enoxaparin), certain antidepressants (including SSRIs such as fluoxetine, SNRIs such as desvenlafaxine/venlafaxine). Other medications can affect the removal of rivaroxaban from your body, which may affect how rivaroxaban works. Examples include cobicistat, conivaptan, dronedarone, ritonavir, certain azole antifungals (itraconazole, ketoconazole, posaconazole), HIV protease inhibitors (such as lopinavir), rifamycins (such as rifampin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others. Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
Allocation Period Weekly
Allocation Period Weekly
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 90
Drug Form Pack Size 90
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 90
Unit Size 90
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking rivaroxaban and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor. If you are taking this drug to prevent strokes and blood clots that may form due to an irregular heartbeat, the dose is usually taken once a day with the evening meal. If you are taking this medication to prevent blood clots due to other conditions (such as after knee or hip replacement surgery, during a hospital stay and after discharge, after Fontan procedure), the dose is usually taken once a day. For adults taking rivaroxaban to treat blood clots, the dose is usually taken twice a day for the first 3 weeks, and then once a day. For children taking rivaroxaban to treat blood clots, the dose is usually taken once a day. If you are taking this medication to lower the risk of blood clots from forming again, the dose is usually taken once a day. Carefully follow your doctor's directions. Do not increase your dose, take it more often, or stop taking it unless you are told to do so by your doctor. The 10 milligrams tablet may be taken with or without food. The 15 milligrams and 20 milligrams tablet should be taken with food. If you have any questions about how to take rivaroxaban, ask your doctor or pharmacist. If you are unable to swallow whole tablets, you may crush the tablet and mix it with applesauce. Eat the entire mixture right away. Do not prepare a supply for future use. If you are giving this medication through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it. The dosage and length of treatment is based on your medical condition and response to treatment. For children, the dosage is also based on weight. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking rivaroxaban and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor. If you are taking this drug to prevent strokes and blood clots that may form due to an irregular heartbeat, the dose is usually taken once a day with the evening meal. If you are taking this medication to prevent blood clots due to other conditions (such as after knee or hip replacement surgery, during a hospital stay and after discharge, after Fontan procedure), the dose is usually taken once a day. For adults taking rivaroxaban to treat blood clots, the dose is usually taken twice a day for the first 3 weeks, and then once a day. For children taking rivaroxaban to treat blood clots, the dose is usually taken once a day. If you are taking this medication to lower the risk of blood clots from forming again, the dose is usually taken once a day. Carefully follow your doctor's directions. Do not increase your dose, take it more often, or stop taking it unless you are told to do so by your doctor. The 10 milligrams tablet may be taken with or without food. The 15 milligrams and 20 milligrams tablet should be taken with food. If you have any questions about how to take rivaroxaban, ask your doctor or pharmacist. If you are unable to swallow whole tablets, you may crush the tablet and mix it with applesauce. Eat the entire mixture right away. Do not prepare a supply for future use. If you are giving this medication through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it. The dosage and length of treatment is based on your medical condition and response to treatment. For children, the dosage is also based on weight. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
Missed Dose MISSED DOSE: If you are taking this medication once a day and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. If you are taking this medication twice a day and miss a dose, take it as soon as you remember. If you missed the morning dose and it is near the time of the evening dose, you may take both doses together. Then take your next dose at the regular time.
Missed Dose MISSED DOSE: If you are taking this medication once a day and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. If you are taking this medication twice a day and miss a dose, take it as soon as you remember. If you missed the morning dose and it is near the time of the evening dose, you may take both doses together. Then take your next dose at the regular time.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as hematocrit/hemoglobin, red blood cell count) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as hematocrit/hemoglobin, red blood cell count) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.
Phonetic Pronunciation (RIV-a-ROX-a-ban)
Phonetic Pronunciation (RIV-a-ROX-a-ban)
Precautions PRECAUTIONS: Before taking rivaroxaban, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, liver disease, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), stroke, artificial heart valves, recent major injury/surgery, blood disorders (such as anemia, hemophilia, thrombocytopenia), frequent falls/injuries, certain eye problem (retinopathy), a certain clotting disorder (antiphospholipid syndrome), certain hereditary enzyme problems (such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption). Before having surgery or any medical/dental procedures (especially spinal puncture or spinal/epidural anesthesia), tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking rivaroxaban before your surgery. Ask for specific instructions about stopping or starting this medication. This medication may cause stomach bleeding. Daily use of alcohol while using this medicine will increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink. This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. If you fall or injure yourself, especially if you hit your head, call your doctor right away. Your doctor may need to check you. Older adults may be more sensitive to the side effects of this drug, especially bleeding. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor before using this medication. This medication may pass into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking rivaroxaban, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, liver disease, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), stroke, artificial heart valves, recent major injury/surgery, blood disorders (such as anemia, hemophilia, thrombocytopenia), frequent falls/injuries, certain eye problem (retinopathy), a certain clotting disorder (antiphospholipid syndrome), certain hereditary enzyme problems (such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption). Before having surgery or any medical/dental procedures (especially spinal puncture or spinal/epidural anesthesia), tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking rivaroxaban before your surgery. Ask for specific instructions about stopping or starting this medication. This medication may cause stomach bleeding. Daily use of alcohol while using this medicine will increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink. This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. If you fall or injure yourself, especially if you hit your head, call your doctor right away. Your doctor may need to check you. Older adults may be more sensitive to the side effects of this drug, especially bleeding. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor before using this medication. This medication may pass into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: nosebleeds that happen often or don't stop, unusual tiredness/weakness, unusual pain/swelling/discomfort, unusual bruising, prolonged bleeding from cuts or gums, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, bloody/black/tarry stools, difficulty swallowing. Get medical help right away if you have any signs of very serious bleeding, including: vision changes, confusion, trouble speaking, weakness on one side of the body. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: See also Warning section. Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: nosebleeds that happen often or don't stop, unusual tiredness/weakness, unusual pain/swelling/discomfort, unusual bruising, prolonged bleeding from cuts or gums, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, bloody/black/tarry stools, difficulty swallowing. Get medical help right away if you have any signs of very serious bleeding, including: vision changes, confusion, trouble speaking, weakness on one side of the body. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Use/discard the crushed tablet mixture within 4 hours. (See also How to Use section.) Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Use/discard the crushed tablet mixture within 4 hours. (See also How to Use section.) Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Rivaroxaban is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge. In addition, rivaroxaban is used to treat blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE) and to prevent the blood clots from forming again. Rivaroxaban may be used in children to prevent blood clots from forming after a certain heart surgery (Fontan procedure). Rivaroxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.
Uses USES: Rivaroxaban is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge. In addition, rivaroxaban is used to treat blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE) and to prevent the blood clots from forming again. Rivaroxaban may be used in children to prevent blood clots from forming after a certain heart surgery (Fontan procedure). Rivaroxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

Frequently Asked Questions(FAQs)

The cost of Xarelto- Rivaroxaban Tablet, Film Coated 20 Mg (90 Tablets) is available for registerd members only .
Xarelto- Rivaroxaban Tablet, Film Coated 20 Mg (90 Tablets) is manufactured by J-O-M PHARM SERVICES.
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