How does this medication work? What will it do for me?
Rivaroxaban belongs to the family of medications called anticoagulants. Anticoagulants prevent harmful blood clots from forming in the blood vessels by reducing the ability of the blood to clot. Rivaroxaban is used to prevent blood clots for people who have had total hip replacement or knee replacement surgery. It is used to treat blood clots for people who have had a deep vein thrombosis (DVT; a blood clot in a major blood vessel, particularly the leg) or pulmonary embolism (blood clot in the lung), and to prevent these clots from happening again.
Rivaroxaban is also used to prevent stroke or blood clots for people with atrial fibrillation.
The low dose of rivaroxaban (2.5 mg) is used in combination with low-doses of acetylsalicylic acid (ASA) to prevent stroke, heart attack, blood clots in the arms and legs, and death for people with coronary artery disease. This combination is also used for people with confirmed peripheral artery disease who are at increased risk for stroke, heart attack, or a blockage of blood flow to the arms or legs.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Tablets
2.5 mg
Each round, biconvex, film-coated, light yellow, immediate-release tablet of 6 mm diameter, with the Bayer Cross on one side and "2.5" and a triangle on the other side, contains 2.5 mg of rivaroxaban. Nonmedicinal ingredients: cellulose microcrystalline, croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate; film coating: ferric oxide yellow, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.
10 mg
Each round, biconvex, light red, film-coated tablet, marked with the Bayer Cross on one side and "10" and a triangle on the other side, contains rivaroxaban 10 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, ferric oxide red, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.
15 mg
Each round, biconvex, red, film-coated tablet, marked with the Bayer Cross on one side and "15" and a triangle on the other side contains rivaroxaban 15 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, ferric oxide red, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.
20 mg
Each round, biconvex, brown-red, film-coated tablet, marked with the Bayer Cross on one side and "20" and a triangle on the other side contains rivaroxaban 20 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, ferric oxide red, hypromellose 15 cP, polyethylene glycol, and titanium dioxide.
Granules for Oral Suspension
Following reconstitution, each mL of the oral suspension contains 1 mg of rivaroxaban. Nonmedicinal ingredients: citric acid, anhydrous, flavour sweet and creamy, hypromellose 5 cp, mannitol, microcrystalline cellulose and carmellose sodium (syn.: microcrystalline cellulose and carboxymethylcellulose sodium), sodium benzoate, sucralose, and xanthan gum.
Supplied as 2.625 g bottle and 5.25 g bottle.
How should I use this medication?
For knee replacement surgery or hip replacement surgery, the usual dose of rivaroxaban is 10 mg taken by mouth, once daily with or without food. This medication is generally started within 6 to 10 hours after the surgery. For hip replacement surgery, the treatment should continue for 35 days. For knee replacement surgery, the treatment should continue for 14 days.
To treat blood clots in the veins of the legs or prevent recurrent blood clots in the lungs or veins of your legs, the recommended starting dose is 15 mg taken two times a day, with food, for 3 weeks. After 3 weeks, the recommended dose is 20 mg taken once a day. The treatments should continue until your physician decides otherwise. After 6 months of treatment for blood clots in the lungs or legs, the dose to continue to prevent blood clots from forming again is 10 mg or 20 mg taken once daily. Your doctor will decide on the dose, depending on your risk of experiencing a new blood clot.
For stroke and clot prevention for people with atrial fibrillation, the usual dose is 20 mg taken by mouth, once daily with food.
To prevent stroke, heart attack, risk of sudden death, or clots blocking blood flow to the legs or arms for people with coronary artery disease, or for people with symptomatic peripheral artery disease the usual dose is 2.5 mg taken by mouth twice daily. One of these doses should be taken at the same time as low-dose ASA.
If you are taking 15 mg or 20 mg at a time, it is suggested that you take this medication with or immediately after food. If you cannot swallow tablets whole, rivaroxaban may be crushed and mixed with a small amount of applesauce immediately before taking the medication.
For infants and children under the age of 18 years, rivaroxaban oral suspension may be used for the treatment of blood clots in the legs or lungs, or to prevent recurrence of clots in the legs or lungs. The dose is based on body weight. Your doctor will calculate the correct dose and the number of times per day it needs to be given. This medication should be given with feeding or with food.
Use the measuring device provided with the container of rivaroxaban suspension to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you or your child are taking the 10 mg, 15 mg, or 20 mg rivaroxaban tablets once daily, and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.
If you are taking 2.5 mg of rivaroxaban two times a day, and you miss a dose, skip the missed dose and continue with your normal schedule. Do not take two doses at once to make up for the missed dose.
If you are taking 15 mg of rivaroxaban two times a day, take the missed dose as soon as you remember and continue with your normal schedule. If it is time for your next dose already take 2 tablets (30 mg total) at once, then continue with your normal dosing schedule the next day. Do not take more than two 15 mg tablets in one day. If your child takes rivaroxaban suspension twice daily and has missed the morning dose, take the dose as soon as you remember and continue with your normal schedule. If it is already time for the evening dose, you may give the forgotten dose together with the evening dose. A missed evening dose can only be given if you remember on the same evening.
If your child takes rivaroxaban suspension three times daily and has missed a dose, skip the missed dose and continue with your regular dosing schedule. Do not take an extra dose to make up for the missed dose.
If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
If you or your child vomits after taking a dose of rivaroxaban, and it is less than 30 minutes since taking the dose, take another dose. If you or your child vomit and it is more than 30 minutes since you took the dose, do not take another dose. Take your next dose at its regular time.
Store rivaroxaban tablets at room temperature and keep them out of the reach of children. Rivaroxaban suspension may be stored at room temperature or in the refrigerator for 14 days after being prepared. If storing in the refrigerator, allow it to warm to room temperature before administering it to your child.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take rivaroxaban if you:
- are allergic to rivaroxaban or any ingredients of the medication
- are bleeding actively or have a high risk of bleeds
- are pregnant or breast-feeding
- are taking certain medications such as cobicistat, dronedarone, ketoconazole, itraconazole, posaconazole, or ritonavir
- are taking other anticoagulants (blood thinners, e.g., warfarin, heparin, low molecular weight heparin, apixaban, dabigatran, edoxaban)
- have a body lesion at risk of bleeding, including active or recent bleeding in the brain, or bleeding in your stomach or gut
- have liver disease associated with an increased risk of bleeding
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- bleeding
- bruising
- constipation
- decreased energy
- diarrhea
- headache
- heartburn
- increased menstrual bleeding
- nausea
- stomach ache
- vomiting
- weakness
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- bleeding or oozing from the surgical wound
- decreased urine production
- fainting
- fast heartbeat
- fever
- itchy skin or skin rash
- pain, swelling, or numbness in the legs or arms
- reddish colour in the urine
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of bleeding (e.g., bloody nose that lasts for more than 5 minutes, blood in urine, coughing blood, cuts that don't stop bleeding, gums that bleed for longer than 5 minutes when brushing teeth, bleeding into the rectum or from hemorrhoids, excessive menstrual bleeding)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- signs of low blood pressure (e.g., dizziness, lightheadedness, fainting)
- stiff, sore, hot, or painful joints
- symptoms of unidentified bleeding (e.g., weakness, paleness, dizziness, headache, unexplained swelling)
- unexpected bruising or bleeding after surgery
- vaginal bleeding (women after menopause)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- seizures
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- signs of a serious allergic reaction (i.e., hives, difficulty breathing, or swelling of the face and throat)
- signs of severe skin reactions (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
HEALTH CANADA ADVISORY
