Xarelto 1 mg/mL oral suspension

Generic name:
Rivaroxaban suspension - oral

Pronunciation
(RIV-a-ROX-a-ban)

Brand name(s)
Xarelto

Do not stop taking rivaroxaban unless directed by your doctor. If you stop taking this medication early, you have a higher risk of forming a serious blood clot (such as a stroke, blood clot in the legs/lungs). Your doctor may direct you to take a different "blood thinning" or antiplatelet medication to reduce your risk. Get medical help right away if you have weakness on one side of the body, trouble speaking, sudden vision changes, confusion, chest pain, trouble breathing, or pain/warmth/swelling in the legs.

People taking this medication may bleed near the spinal cord after certain spinal procedures. Bleeding in this area can cause paralysis that lasts a long time or could become permanent. Before any spinal procedure, ask your doctor about the benefits and risks. The risk of bleeding may be higher if you have a deformed spine, or have had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or are taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/enoxaparin, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence).

Rivaroxaban suspension 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. It may also be used 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.

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using rivaroxaban suspension and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Some brands of this medication are prepared by a health care professional, while other brands may give you instructions for how to prepare the suspension before use. Carefully read and follow the manufacturer's directions for your brand of rivaroxaban suspension.

Take this medication by mouth as directed by your doctor, usually 1 to 3 times a day. Follow your doctor's directions for taking this medication with or without food. If your brand of medication is stored in the refrigerator, allow the suspension to come to room temperature before giving each dose. Do not warm up this medication any other way such as by heating in the microwave or placing the bottle in hot water. Shake the bottle well for at least 10 seconds before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. After each dose, drink/give some liquid to make sure all of the dose is taken.

If you or the child spits up or vomits less than 30 minutes after taking the dose, take or give another dose. If this happens more than 30 minutes after the dose, do not take or give a new dose. Take/give the next dose at the usual time.

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.

Do not increase your dose, take it more often, or stop taking it unless you are told to do so by your doctor.

The dosage and length of treatment are based on your medical condition, weight, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

See also Warning section.

Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If either of these effects lasts or gets 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.

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
• a 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 contain sugar or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

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.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before breastfeeding.

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 are:

• 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, 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 told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.

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.

If you are taking this medication once a day and miss a dose, take it as soon as you remember. If you don't remember until the next day, skip the missed dose. 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 have missed the morning dose and it is near the time of the evening dose, you may take both doses together. If you miss the evening dose, take it as soon as you remember only if you remember on the same evening.

If you are taking this medication 3 times a day (about 8 hours apart) and miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

On the following day, continue with the regular once, twice, or three-times-daily schedule as directed by the doctor.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

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.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.