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Introduction About RIVOLAS 10 TABLET
RIVOLAS 10 TABLET contains Rivaroxaban, which belongs to the group of medicines called Antithrombotic agents. It is used to manage 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 management 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 RIVOLAS 10 TABLET, inform your doctor if you have any liver, kidney, or bleeding problems or antiphospholipid syndrome. RIVOLAS 10 TABLET is not recommended for use in pregnant or breast-feeding women, so consult your doctor before taking it. RIVOLAS 10 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. RIVOLAS 10 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 RIVOLAS 10 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 RIVOLAS 10 TABLET
It is used:
- To manage deep vein thrombosis (DVT), pulmonary embolism (PE), venous thromboembolism (VTE)
- To 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)
- To manage 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 RIVOLAS 10 TABLET Works
RIVOLAS 10 TABLET works by competitively inhibiting factor Xa (a clotting factor) and managing the progression of the coagulation cascade through the final common pathway, thus managing thrombin generation.
How to use RIVOLAS 10 TABLET
Take RIVOLAS 10 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 RIVOLAS 10 TABLET unless your doctor advise.
Side Effects Of RIVOLAS 10 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
- Oozing of blood or fluid from surgical injury
- Impaired kidney function
- 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 RIVOLAS 10 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
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 RIVOLAS 10 TABLET without consulting your doctor.
Dizziness Or Drowsiness
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.
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.
Nausea And Vomiting
Take RIVOLAS 10 TABLET with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. 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 RIVOLAS 10 TABLET without asking your doctor.
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.
Warning & Precautions
Pregnancy
ContraindicatedRIVOLAS 10 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
ContraindicatedRIVOLAS 10 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
Use with CautionDo not drive or operate any machines if you feel dizzy after taking RIVOLAS 10 TABLET.
Kidney
Use with CautionRIVOLAS 10 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 RIVOLAS 10 TABLET.
Liver
ContraindicatedRIVOLAS 10 TABLET is not recommended for use in patients with liver disease which leads to an increased risk of bleeding. Consult your doctor before taking RIVOLAS 10 TABLET.
Allergy
ContraindicatedDo not take RIVOLAS 10 TABLET if you are allergic to Rivaroxaban or any of the other ingredients of this medicine.
Lungs
Use with CautionRIVOLAS 10 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 RIVOLAS 10 TABLET.
Heart Disease
Consult your doctorRIVOLAS 10 TABLET is not recommended for use in patients with acute coronary syndrome, coronary artery disease, or peripheral artery disease. RIVOLAS 10 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 RIVOLAS 10 TABLET.
Use In Pediatrics
ContraindicatedRIVOLAS 10 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. RIVOLAS 10 TABLET is not recommended for use in children with moderate to severe kidney disease. Consult your doctor before taking RIVOLAS 10 TABLET.
Use In Geriatrics
Use with CautionRIVOLAS 10 TABLET should be used with caution in elderly patients (aged above 75 years). Consult your doctor before taking RIVOLAS 10 TABLET.
Others
RIVOLAS 10 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 RIVOLAS 10 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
Interactions
A. Drug-Drug interactions:
Before taking RIVOLAS 10 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 manage 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 manage inflammation and pain (Ex. naproxen, acetylsalicylic acid)
- Dronedarone (used to manage abnormal heartbeat)
- Medicines used to manage depression (Ex. citalopram, fluoxetine, venlafaxine, duloxetine, St. John’s wort)
- Medicines used to manage fits (Ex. carbamazepine, phenytoin, phenobarbital)
Overdosage:
If you or anyone else accidentally take too much of RIVOLAS 10 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 | : | Manage deep Vein thrombosis (DVT), Pulmonary embolism (PE), Venous thromboembolism (VTE) |
| Dosage Forms | : | Tablet |
More Information
Storage
- Keep RIVOLAS 10 TABLET out of reach from children
- Store RIVOLAS 10 TABLET between 15-30°C
FAQs About RIVOLAS 10 TABLET
Q: Can I take RIVOLAS 10 TABLET before surgery?
A: It is very important to take RIVOLAS 10 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.
Q: Can RIVOLAS 10 TABLET be crushed?
A: If you have difficulty swallowing RIVOLAS 10 TABLET whole, ask your doctor about other ways to take RIVOLAS 10 TABLET. RIVOLAS 10 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.
Q: What if I forget to take a dose of RIVOLAS 10 TABLET?
A: If you forget to take a dose of RIVOLAS 10 TABLET, take it as soon as you remember and continue the management as per your prescribed schedule. Do not take RIVOLAS 10 TABLET twice to make up for a forgotten dose.
Q: Can RIVOLAS 10 TABLET be used in pregnancy?
A: Before taking RIVOLAS 10 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 RIVOLAS 10 TABLET can harm your unborn baby. Tell your doctor immediately if you become pregnant during management with RIVOLAS 10 TABLET. If you take RIVOLAS 10 TABLET during pregnancy, inform your doctor right away if you see any signs or symptoms of bleeding or blood loss.
Q: What if I spit or vomit a dose of RIVOLAS 10 TABLET?
A: If you spit up or vomit a dose of RIVOLAS 10 TABLET less than 30 minutes after you have taken it, take a new dose. If you spit RIVOLAS 10 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 RIVOLAS 10 TABLET doses.
Q: Can RIVOLAS 10 TABLET be used in infants?
A: RIVOLAS 10 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. RIVOLAS 10 TABLET is also not recommended in children with moderate to severe kidney disease. Consult your doctor before taking it.
Q: Can I stop taking RIVOLAS 10 TABLET?
A: If you need to stop taking RIVOLAS 10 TABLET for any reason, ask your doctor to find out when you should stop taking it. Do not stop taking RIVOLAS 10 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 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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