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Rivaroxaban (Oral route)

Pronunciation:

riv-a-ROX-a-ban

Brand Names:

  • Xarelto

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Premature discontinuation of any oral anticoagulant, including rivaroxaban, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if rivaroxaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy. Epidural or spinal hematomas, which may result in long-term or permanent paralysis, have occurred in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing spinal puncture. Optimal timing between the administration of rivaroxaban and neuraxial procedures is not known. Factors that can increase the risk of developing these hematomas include: use of indwelling epidural catheters; concomitant use of drugs affecting hemostasis, such as NSAIDs, platelet inhibitors, or other anticoagulants; or history of traumatic or repeated epidural or spinal puncture, spinal deformity, or spinal surgery. Monitor patients frequently for neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider risks/benefits before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis .

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Factor Xa Inhibitor

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Breast-feeding—

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.

Other medicines—

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
  • 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
  • Tenecteplase
  • Tenoxicam
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tocophersolan
  • Tolfenamic Acid
  • Tolmetin
  • Urokinase
  • Valdecoxib
  • 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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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
Back pain
bleeding gums
bloody stools
bowel or bladder dysfunction
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
coughing up blood
difficulty with breathing or swallowing
dizziness
headache
increased menstrual flow or vaginal bleeding
leg weakness
nosebleeds
numbness
paralysis
prolonged bleeding from cuts
red or black, tarry stools
red or dark brown urine
vomiting of blood or material that looks like coffee grounds
Less common
Fainting
pain in the arms or legs
wound secretion
Rare
Burning while urinating
difficult or painful urination
Incidence not known
Abdominal or stomach pain or swelling
blistering, peeling, or loosening of the skin
blurred vision
chills
clay-colored stools
cough or hoarseness
dark urine
diarrhea
fast or irregular heartbeat
fever with or without chills
general feeling of tiredness or weakness
hives
itching
joint or muscle pain
loss of appetite
lower back or side pain
nausea or vomiting
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red skin lesions, often with a purple center
red, irritated eyes
severe headache
skin rash
sore throat
sores, ulcers, or white spots in the mouth or on the lips
tightness in the chest
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
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
Blisters
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.


Last Updated: 4/4/2014

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