INTRODUCTION
XARELTO 20MG TABLET contains Rivaroxaban, which belongs to the group of medicines called Antithrombotic agents. It is used to treat deep vein thrombosis (DVT), pulmonary embolism (PE), and venous thromboembolism (VTE). It is also used to reduce the risk of stroke, systemic embolism in nonvalvular atrial fibrillation, recurrence of DVT or PE, major cardiovascular events in patients with coronary artery disease (CAD), and major thrombotic vascular events in patients with peripheral artery disease (PAD). Venous thromboembolism is a condition that occurs due to clot formation in the venous circulation.
It can also be used for THE prevention of DVT in patients undergoing knee or hip replacement surgery, VTE in acutely ill medical patients, and thrombosis in children (older than 2 years) with congenital heart disease post the Fontan procedure.
Before taking XARELTO 20MG TABLET, inform your doctor if you have any liver, kidney, or bleeding problems or antiphospholipid syndrome. XARELTO 20MG TABLET is not recommended for use in pregnant or breast-feeding women, so consult your doctor before taking it.
XARELTO 20MG TABLET is not studied and is not recommended in children less than 6 months of age who were less than 37 weeks of growth at birth, had less than 10 days of oral feeding, or weigh less than 2.6 kg. XARELTO 20MG TABLET should be used with caution in elderly patients (65 years or older). Consult your doctor before taking it.
The most common side effects of taking XARELTO 20MG TABLET are bleeding, pain and swelling in the limbs, fever, stomach pain, indigestion, nausea, vomiting, constipation, diarrhea, low blood pressure (feeling dizzy or fainting when standing up), weakness, tiredness, headache, dizziness, rash, and itchy skin. Contact your doctor if any of your symptoms worsen.
USES OF XARELTO 20MG TABLET
It is used:
- Treats deep vein thrombosis (DVT), pulmonary embolism (PE), venous thromboembolism (VTE)
- Reduces the risk of stroke, systemic embolism in nonvalvular atrial fibrillation, recurrence of DVT or PE, major cardiovascular events in patients with coronary artery disease (CAD), and major thrombotic vascular conditions in patients with peripheral artery disease (PAD)
- Prevention of DVT in patients undergoing knee or hip replacement surgery, VTE in acutely ill medical patients, and thrombosis in children (2 years and older) with congenital heart disease post the Fontan procedure
HOW XARELTO 20MG TABLET WORKS
XARELTO 20MG TABLET works by competitively inhibiting factor Xa (a clotting factor) and preventing the progression of the coagulation cascade through the final common pathway, thus preventing thrombin generation.
DIRECTIONS FOR USE
Take XARELTO 20MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking XARELTO 20MG TABLET unless your doctor advises.
SIDE EFFECTS OF XARELTO 20MG TABLET
COMMON
- decrease in red blood cells (pale skin, weakness, or breathlessness)
- bleeding in the stomach or intestine, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nosebleed, bleeding in the gum
- bleeding into the eye (including from the whites of the eyes)
- hematoma, bruising (bleeding into tissue or a cavity of the body)
- coughing up blood
- bleeding from or under the skin
- bleeding after an operation
- oozing of blood or fluid from surgical injury
- impaired kidney function (may be seen in tests performed by your doctor)
- pain and swelling in the limbs
- fever
- stomach pain, indigestion, nausea, vomiting, constipation, diarrhea
- low blood pressure (feeling dizzy or fainting when standing up)
- weakness, tiredness, headache, dizziness
- rash, itchy skin
UNCOMMON
- bleeding into the brain or inside the skull, or into a joint (pain and swelling)
- low number of platelets
- allergic reactions including skin reactions
- fainting
- feeling unwell
- rapid heartbeat
- dry mouth
- hives
RARE
- bleeding into a muscle
- decreased bile flow, inflamed liver including liver injury
- yellowing of the skin and eye
- localized swelling
- accumulation of blood in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery
Stop taking XARELTO 20MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- bleeding inside brain (headache, one-sided weakness, vomiting, seizures, decreased level of consciousness, neck stiffness); long or excessive bleeding; abnormal weakness, tiredness, paleness, dizziness, unexplained swelling, breathlessness, chest pain; frequent nose bleeds; abnormal bleeding from the gums; menstrual bleeding that is heavier than normal or vaginal bleeding; bleeding that is severe or uncontrollable; red, pink or brown urine; bright red or black tar-like stools; cough up blood or blood clots; vomit blood or your vomit looks like “coffee grounds”; pain, swelling, or new drainage at wound sites
- severe skin reactions (spreading intense skin rash, blisters or mucosal lesions in the mouth or eyes, a drug reaction that causes rash, fever, inflammation of internal organs, blood abnormalities and systemic illness)
- severe allergic reaction (swelling of the face, lips, mouth, tongue, or throat; trouble swallowing; hives and breathing difficulties; sudden drop in blood pressure)
- spinal or epidural blood clots
- back pain
- muscle weakness (legs and feet)
- tingling
- bowel or bladder incontinence
- numbness
HOW TO MANAGE SIDE EFFECTS
Stomach pain:
Try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.
Nausea:
Take XARELTO 20MG TABLET with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods.
Vomiting:
Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like it – you do not need to eat or avoid any specific foods. Do not take any medicine other than XARELTO 20MG TABLET without asking your doctor.
Constipation:
Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly.
Diarrhea:
Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine other than XARELTO 20MG TABLET without consulting your doctor.
Headache:
Drink ample amount of water. Get adequate rest. Try to be relaxed and stress free. Ask your doctor before taking any medicine for headache.
Dizziness:
Lie down until dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol, and drugs.
WARNING & PRECAUTIONS
PREGNANCY
XARELTO 20MG TABLET is not recommended for use in pregnant women as it not known if it causes any harm to the unborn baby. Consult your doctor before taking it.
BREASTFEEDING
XARELTO 20MG TABLET is not recommended for use in breastfeeding women as it may pass through the breast milk. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy after taking XARELTO 20MG TABLET.
KIDNEY
XARELTO 20MG TABLET should be taken with caution in adults with severe kidney disease and children with moderate or severe kidney disease. Consult your doctor before taking XARELTO 20MG TABLET.
LIVER
XARELTO 20MG TABLET is not recommended for use in patients with liver disease which leads to an increased risk of bleeding. Consult your doctor before taking XARELTO 20MG TABLET.
ALLERGY
Do not take XARELTO 20MG TABLET if you are allergic to Rivaroxaban or any of the other ingredients of this medicine.
LUNGS
XARELTO 20MG TABLET should be used with caution in patients with lung disease where the bronchi are widened and filled with pus, or those with previous bleeding from the lung. Consult your doctor before taking XARELTO 20MG TABLET.
HEART DISEASE
XARELTO 20MG TABLET is not recommended for use in patients with acute coronary syndrome, coronary artery disease, or peripheral artery disease. XARELTO 20MG TABLET should be taken with caution in patients with very high or unstable blood pressure which is not controlled by medicines, prosthetic heart valve, or coronary artery disease with severe symptomatic heart failure. Consult your doctor before taking XARELTO 20MG TABLET.
OTHERS
XARELTO 20MG TABLET is not recommended for use if you:
- are bleeding excessively
- have a disease or condition in an organ of the body that increases the risk of serious bleeding (Ex. stomach ulcer, injury or bleeding in the brain, recent operation of the brain or eyes)
- had stroke (previously had a bleeding or a blood clot in your brain)
- had lacunar stroke (blockage of the small arteries providing blood to the brain’s deep tissues) or ischemic, nonlacunar stroke (blood clot in your brain) in the previous month
Before taking XARELTO 20MG TABLET, inform your doctor if you:
- have or had bleeding problems
- have antiphospholipid syndrome (immunity disorder that causes an increased risk of blood clots)
- have diseases of your stomach or bowel that might result in bleeding (Ex. inflammation of the bowels, stomach, or food pipe) or tumours in the stomach, bowels, genital tract, or urinary tract)
- have retinopathy (problem with the blood vessels in the back of your eyes)
- need to have an operation
- weigh less than 60 kg
Use in pediatrics:
XARELTO 20MG TABLET is not studied and is not recommended for use in children less than 6 months of age who were less than 37 weeks of growth at birth, had less than 10 days of oral feeding, or weigh 2.6 kg. XARELTO 20MG TABLET is not recommended for use in children with moderate to severe kidney disease. Consult your doctor before taking XARELTO 20MG TABLET.
Use in geriatrics:
XARELTO 20MG TABLET should be used with caution in elderly patients (aged above 75 years). Consult your doctor before taking XARELTO 20MG TABLET.
INTERACTIONS
A. Drug - Drug interactions:
Before taking XARELTO 20MG TABLET, inform your doctor if you are taking any of the following medicine:
- medicines used for fungal infections (Ex. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used on the skin
- ketoconazole (used to treat Cushing’s syndrome)
- medicines used for bacterial infections (Ex. clarithromycin, erythromycin, rifampicin)
- medicines used for HIV infection (Ex. ritonavir, indinavir)
- other medicines used to reduce blood clotting (Ex. enoxaparin, clopidogrel, warfarin, apixaban, heparin, acenocoumarol, prasugrel, ticagrelor)
- medicines used to treat inflammation and pain (Ex. naproxen, acetylsalicylic acid)
- dronedarone (used to treat abnormal heartbeat)
- medicines used to treat depression (Ex. citalopram, fluoxetine, venlafaxine, duloxetine, St. John’s wort)
- medicines used to treat fits (Ex. carbamazepine, phenytoin, phenobarbital)
Overdosage:
If you or anyone else accidentally take too much of XARELTO 20MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptom of overdose include bleeding.
SYNOPSIS
| Drug | : | Rivaroxaban |
| Pharmacological Category | : | Factor Xa inhibitor |
| Therapeutic Indication | : | Treatment and prevention of deep vein thrombosis (DVT), pulmonary embolism (PE), and venous thromboembolism (VTE) |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep XARELTO 20MG TABLET out of reach from children
- Store XARELTO 20MG TABLET between 15-30°C
FAQs ABOUT XARELTO 20MG TABLET
Can I take XARELTO 20MG TABLET before surgery?
It is very important to take XARELTO 20MG TABLET before and after any surgery (including a catheter or injection into your spinal cord) exactly at the times advised by your doctor. Inform your doctor immediately if you get numbness or weakness in your legs or problems with your bowels or bladder after the end of anesthesia, because urgent care is required.
Can XARELTO 20MG TABLET be crushed?
If you have difficulty swallowing XARELTO 20MG TABLET whole, ask your doctor about other ways to take XARELTO 20MG TABLET. XARELTO 20MG TABLET may be crushed and mixed with water or a soft food such as apple puree just before you take it. If required, your doctor may give you the crushed medicine through a stomach tube.
What if I forget to take a dose of XARELTO 20MG TABLET?
If you forget to take a dose of XARELTO 20MG TABLET, take it as soon as you remember and continue the treatment as per your prescribed schedule. Do not take XARELTO 20MG TABLET twice to make up for a forgotten dose.
Can XARELTO 20MG TABLET be used in pregnancy?
Before taking XARELTO 20MG TABLET, inform your doctor if you are pregnant or planning to become pregnant, as it may increase the risk of bleeding in you (uterine) or in your unborn baby. It is not known if XARELTO 20MG TABLET can harm your unborn baby. Tell your doctor immediately if you become pregnant during treatment with XARELTO 20MG TABLET. If you take XARELTO 20MG TABLET during pregnancy, inform your doctor right away if you see any signs or symptoms of bleeding or blood loss.
What if I spit or vomit a dose of XARELTO 20MG TABLET?
If you spit up or vomit a dose of XARELTO 20MG TABLET less than 30 minutes after you have taken it, take a new dose. If you spit XARELTO 20MG TABLET up more than 30 minutes after you took it, do not take a new dose and take the next one at the usual time. Contact the doctor if you repeatedly spit up or vomit XARELTO 20MG TABLET doses.
Can XARELTO 20MG TABLET be used in infants?
XARELTO 20MG TABLET is not studied and is not recommended in children less than 6 months of age who were less than 37 weeks of growth at birth, had less than 10 days of oral feeding, or weigh less than 2.6 kg. XARELTO 20MG TABLET is also not recommended in children with moderate to severe kidney disease. Consult your doctor before taking it.
Can I stop taking XARELTO 20MG TABLET?
If you need to stop taking XARELTO 20MG TABLET for any reason, ask your doctor to find out when you should stop taking it. Do not stop taking XARELTO 20MG TABLET without consulting your doctor first.
REFERENCES
1. Barbara G. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Venous Thromboembolism. Pharmacotherapy Handbook. Ninth edition. Page- 125, 126.
2 Rajshree Singh, Prabhu D. Emmady. Rivaroxaban. StatPearls [Internet]. StatPearls Publishing. May 2022. [Accessed on 1st June 2022] https://www.ncbi.nlm.nih.gov/books/NBK557502/#article-86483.s3
3. Bayer AG. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on 1st June 2022] https://www.medicines.org.uk/emc/files/pil.3410.pdf
4. Bayer (Pty) Ltd. Rivaroxaban. [Revised in May 2022] [Accessed on 1st June 2022] https://www.bayer.com/sites/default/files/XARELTO_10_ENG_PIL.pdf
5. Janssen Pharmaceuticals, Inc. Rivaroxaban. [Revised in January 2022] [Accessed on 1st June 2022] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/XARELTO-pi.pdf
USEFUL DIAGNOSTIC TESTS
- D-dimer blood test
- Duplex ultrasound
- Venography
- Magnetic resonance imaging (MRI) scan
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