Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Xarelto

Descriptions


Rivaroxaban is used to treat and prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. This medicine is used for several days after hip or knee replacement surgery while you are unable to walk. It is during this time that blood clots are most likely to form.

Rivaroxaban is also used to prevent stroke and blood clots in patients with certain heart rhythm problem (eg, nonvalvular atrial fibrillation).

Rivaroxaban is a factor Xa inhibitor, an anticoagulant. It works by decreasing the clotting ability of the blood and helps preventing harmful clots from forming in the blood vessels.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rivaroxaban in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rivaroxaban in the elderly. However, elderly patients are more likely to have bleeding and blood clotting problems and age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving rivaroxaban.

Pregnancy

Information about this rivaroxaban-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Alipogene Tiparvovec
  • Alteplase, Recombinant
  • Amtolmetin Guacil
  • Anistreplase
  • Apixaban
  • Argatroban
  • Aspirin
  • Bivalirudin
  • Boceprevir
  • Bromfenac
  • Bufexamac
  • Carbamazepine
  • Celecoxib
  • Choline Salicylate
  • Cilostazol
  • Clonixin
  • Clopidogrel
  • Cobicistat
  • Collagenase, Clostridium histolyticum
  • Conivaptan
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyridamole
  • Dipyrone
  • Drotrecogin Alfa
  • Enoxaparin
  • Eptifibatide
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenofibrate
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Fondaparinux
  • Fosphenytoin
  • Heparin
  • Ibuprofen
  • Ibuprofen Lysine
  • Indinavir
  • Indomethacin
  • Itraconazole
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lepirudin
  • Levomilnacipran
  • Lomitapide
  • Lopinavir
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nelfinavir
  • Nepafenac
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Pentosan Polysulfate Sodium
  • Phenindione
  • Phenobarbital
  • Phenprocoumon
  • Phenylbutazone
  • Phenytoin
  • Piketoprofen
  • Piroxicam
  • Posaconazole
  • Pranoprofen
  • Prasugrel
  • Primidone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C, Human
  • Reteplase, Recombinant
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Saquinavir
  • Simeprevir
  • Sodium Salicylate
  • St John's Wort
  • Streptokinase
  • Sulfinpyrazone
  • Sulindac
  • Telaprevir
  • Tenecteplase
  • Tenoxicam
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tipranavir
  • Tirofiban
  • Tocophersolan
  • Tolfenamic Acid
  • Tolmetin
  • Ulipristal
  • Urokinase
  • Valdecoxib
  • Vorapaxar
  • Voriconazole
  • Vortioxetine
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clarithromycin
  • Fluconazole

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Blood vessel problems or
  • Catheter insertion in the spine or
  • Liver disease, moderate and severe or
  • Stomach or intestinal ulcer or bleeding or
  • Stroke, recent or history of or
  • Surgery (eg, eye, brain, spine), recent or history of—Use with caution. The risk of bleeding may be increased.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Major bleeding, active or
  • Prosthetic heart valve—Should not be used in patients with this condition.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

The 10-mg tablets can be taken with or without food. The 15 and 20 mg tablets should be taken with food. Also, take this medicine at the same time each day.

If you are unable to swallow the tablets whole:

  • The 15- or 20-mg tablets may be crushed and mixed with a small amount of applesauce. This must be taken immediately followed by food.
  • If you are using a nasogastric tube or gastric feeding tube: The 15- or 20-mg tablets may be crushed and suspended in 50 milliliter (mL) of water before administering it via the tube. This must be followed by enteral feeding.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For prevention of deep venous thrombosis (hip replacement surgery):
      • Adults—10 milligrams (mg) once a day for 35 days. The starting dose should be taken at least 6 to 10 hours after surgery.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of deep venous thrombosis (knee replacement surgery):
      • Adults—10 milligrams (mg) once a day for 12 days. The starting dose should be taken at least 6 to 10 hours after surgery.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of reoccurring deep venous thrombosis and pulmonary embolism:
      • Adults—20 milligrams (mg) once a day with food.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of stroke and blood clots in patients with nonvalvular atrial fibrillation:
      • Adults—15 or 20 milligrams (mg) once a day, taken with the evening meal.
      • Children—Use and dose must be determined by your doctor.
    • For treatment of deep venous thrombosis and pulmonary embolism:
      • Adults—At first, 15 milligrams (mg) two times a day, taken with food for the first 21 days. Then, your doctor may give you 20 mg once a day, taken at the same time each day with food.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

If you take this medicine once a day: If you miss a dose, take it as soon as you can on the same day. Then take the next dose at the regularly scheduled time on the next day.

If you take this medicine 2 times a day to treat a blood clot: If you miss a dose, take it as soon as you can on the same day. You may take 2 doses at the same time to make up for the missed dose. Then take your regularly scheduled doses on the next day.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects. Be sure to keep all appointments.

You may bleed or bruise more easily while you are using this medicine. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Be careful when using sharp objects, including razors and fingernail clippers. Avoid nose picking and forceful nose blowing.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

This medicine may cause bleeding problems. This risk is higher if you have a catheter in your back for pain medicine or anesthesia (sometimes called an "epidural"), or if you have kidney problems. The risk of bleeding increases if your kidney problems get worse. Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, bleeding gums, blood in the urine or stools, tingling, numbness, or weakness of the lower legs, or pinpoint red spots on your skin.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Do not suddenly stop taking this medicine without first checking with your doctor. Doing so, may increase risk of having a stroke.

Make sure your doctor knows if you are pregnant or planning to become pregnant during treatment with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Back pain
  2. bleeding gums
  3. bloody stools
  4. bowel or bladder dysfunction
  5. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  6. coughing up blood
  7. difficulty with breathing or swallowing
  8. dizziness
  9. headache
  10. increased menstrual flow or vaginal bleeding
  11. leg weakness
  12. nosebleeds
  13. numbness
  14. paralysis
  15. prolonged bleeding from cuts
  16. red or black, tarry stools
  17. red or dark brown urine
  18. vomiting of blood or material that looks like coffee grounds

Less common

  1. Fainting
  2. pain in the arms or legs
  3. wound secretion

Rare

  1. Burning while urinating
  2. difficult or painful urination

Incidence not known

  1. Abdominal or stomach pain or swelling
  2. blistering, peeling, or loosening of the skin
  3. blurred vision
  4. chills
  5. clay-colored stools
  6. cough or hoarseness
  7. dark urine
  8. diarrhea
  9. fast or irregular heartbeat
  10. fever with or without chills
  11. general feeling of tiredness or weakness
  12. hives
  13. itching
  14. joint or muscle pain
  15. loss of appetite
  16. lower back or side pain
  17. nausea or vomiting
  18. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  19. red skin lesions, often with a purple center
  20. red, irritated eyes
  21. severe headache
  22. skin rash
  23. sore throat
  24. sores, ulcers, or white spots in the mouth or on the lips
  25. tightness in the chest
  26. unpleasant breath odor
  27. unusual bleeding or bruising
  28. unusual tiredness or weakness
  29. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Blisters
  2. muscle spasm

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.