Xarelto

Brand Name

Xarelto

Common Name

rivaroxaban

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

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.

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 2 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 2 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 3 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.

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.

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, 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?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Heart valve disease: Rivaroxaban is not recommended for people who have artificial heart valves or have had artificial aortic valve replacement.

Increased bleeding risk: If you have conditions that are associated with an increased risk of bleeding (e.g., bleeding problems; uncontrolled very high blood pressure; a problem with the blood vessels in the back of the eye called retinopathy; current or past ulcer of the stomach or intestines; recent stroke; or recent surgery of the brain, spinal column, or eye), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney disease: Decreased kidney function or kidney disease can cause rivaroxaban to build up in the body, causing side effects. If you have kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactose: This medication contains lactose. People with certain rare problems associated with lactose or galactose intolerance (e.g., Lapp lactase deficiency, glucose-galactose malabsorption) should not take this medication.

Liver disease: If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Spinal or epidural injection or catheters: If you have a spinal or epidural catheter, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Surgery: Inform all health care professionals involved in your care that you are taking rivaroxaban. Rivaroxaban may need to be stopped temporarily before dental or surgical procedures to reduce your risk of bleeding heavily during or after the procedure.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Rivaroxaban may pass into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. This medication should not be taken while breast-feeding.

Children: The safety and effectiveness of using this medication for conditions other than the treatment of blood clots in the legs or lungs, or to prevent the recurrence of clots in the legs or lungs have not been established for children less than 18 years of age.

Seniors: The side effects of this medication may be more noticeable in seniors. People who are over 65 years old should discuss with their doctor how this medication may affect them and whether any special monitoring is needed.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Xarelto