INTRODUCTION
RIVALTO 2.5 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 RIVALTO 2.5 TABLET, inform your doctor if you have any liver, kidney, or bleeding problems or antiphospholipid syndrome. RIVALTO 2.5 TABLET is not recommended for use in pregnant or breast-feeding women, so consult your doctor before taking it.
RIVALTO 2.5 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. RIVALTO 2.5 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 RIVALTO 2.5 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 RIVALTO 2.5 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 RIVALTO 2.5 TABLET WORKS
RIVALTO 2.5 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 RIVALTO 2.5 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 RIVALTO 2.5 TABLET unless your doctor advises.
SIDE EFFECTS OF RIVALTO 2.5 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 RIVALTO 2.5 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 RIVALTO 2.5 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 RIVALTO 2.5 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 RIVALTO 2.5 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
RIVALTO 2.5 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
RIVALTO 2.5 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 RIVALTO 2.5 TABLET.
KIDNEY
RIVALTO 2.5 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 RIVALTO 2.5 TABLET.
LIVER
RIVALTO 2.5 TABLET is not recommended for use in patients with liver disease which leads to an increased risk of bleeding. Consult your doctor before taking RIVALTO 2.5 TABLET.
ALLERGY
Do not take RIVALTO 2.5 TABLET if you are allergic to Rivaroxaban or any of the other ingredients of this medicine.
LUNGS
RIVALTO 2.5 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 RIVALTO 2.5 TABLET.
HEART DISEASE
RIVALTO 2.5 TABLET is not recommended for use in patients with acute coronary syndrome, coronary artery disease, or peripheral artery disease. RIVALTO 2.5 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 RIVALTO 2.5 TABLET.
OTHERS
RIVALTO 2.5 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 RIVALTO 2.5 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:
RIVALTO 2.5 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. RIVALTO 2.5 TABLET is not recommended for use in children with moderate to severe kidney disease. Consult your doctor before taking RIVALTO 2.5 TABLET.
Use in geriatrics:
RIVALTO 2.5 TABLET should be used with caution in elderly patients (aged above 75 years). Consult your doctor before taking RIVALTO 2.5 TABLET.
INTERACTIONS
A. Drug - Drug interactions:
Before taking RIVALTO 2.5 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 RIVALTO 2.5 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 RIVALTO 2.5 TABLET out of reach from children
- Store RIVALTO 2.5 TABLET between 15-30°C
FAQs ABOUT RIVALTO 2.5 TABLET
Can I take RIVALTO 2.5 TABLET before surgery?
It is very important to take RIVALTO 2.5 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 RIVALTO 2.5 TABLET be crushed?
If you have difficulty swallowing RIVALTO 2.5 TABLET whole, ask your doctor about other ways to take RIVALTO 2.5 TABLET. RIVALTO 2.5 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 RIVALTO 2.5 TABLET?
If you forget to take a dose of RIVALTO 2.5 TABLET, take it as soon as you remember and continue the treatment as per your prescribed schedule. Do not take RIVALTO 2.5 TABLET twice to make up for a forgotten dose.
Can RIVALTO 2.5 TABLET be used in pregnancy?
Before taking RIVALTO 2.5 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 RIVALTO 2.5 TABLET can harm your unborn baby. Tell your doctor immediately if you become pregnant during treatment with RIVALTO 2.5 TABLET. If you take RIVALTO 2.5 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 RIVALTO 2.5 TABLET?
If you spit up or vomit a dose of RIVALTO 2.5 TABLET less than 30 minutes after you have taken it, take a new dose. If you spit RIVALTO 2.5 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 RIVALTO 2.5 TABLET doses.
Can RIVALTO 2.5 TABLET be used in infants?
RIVALTO 2.5 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. RIVALTO 2.5 TABLET is also not recommended in children with moderate to severe kidney disease. Consult your doctor before taking it.
Can I stop taking RIVALTO 2.5 TABLET?
If you need to stop taking RIVALTO 2.5 TABLET for any reason, ask your doctor to find out when you should stop taking it. Do not stop taking RIVALTO 2.5 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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