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INTRODUCTION
REVOLADE 50MG TABLET contains Eltrombopag which belongs to the group of medicines called Thrombopoietin-receptor agonist. REVOLADE 50MG TABLET is used to treat immune thrombocytopenia (platelet disorder) in patients aged 1-year/above when other medicines (such as corticosteroids/immunoglobulins) become ineffective to treat the disease.
REVOLADE 50MG TABLET is also used to treat thrombocytopenia (low platelet count) in adults suffering from hepatitis C (viral) infection. The medicine is also indicated for use to treat low blood counts in adults suffering from severe aplastic anemia (rare blood disorder that occurs due to failure of bone marrow to produce new blood cells).
REVOLADE 50MG TABLET is not recommended for use in patients allergic to Eltrombopag.
Before taking REVOLADE 50MG TABLET, inform your doctor if you are at a risk of developing blood clot in veins/arteries, and/or have cancer, obesity, advanced chronic liver disease, and/or kidney problems (such as renal impairment).
REVOLADE 50MG TABLET is generally not recommended for use during pregnancy unless it is clearly necessary. Women of childbearing potential should use effective contraceptive measures while in treatment with REVOLADE 50MG TABLET. It is also not recommended for use in breastfeeding women since it is not known whether the medicine may pass through breastmilk.
REVOLADE 50MG TABLET is not recommended for use in children (aged below 1-year) suffering from immune thrombocytopenia. It is also not recommended for use in children (aged below 18 years) suffering from low platelet counts due to hepatitis C/severe aplastic anemia. The medicine is advised to be used with caution in elderly patients (aged 65 years/above) after taking the medicine.
The most common side effects of taking REVOLADE 50MG TABLET are common cold, cough, nausea, vomiting, diarrhea, constipation, and/or hair loss. Consult your doctor if any of these symptoms worsens.
USES OF REVOLADE 50MG TABLET
- Treats immune thrombocytopenia (platelet disorder)
- Treats thrombocytopenia in adults suffering from hepatitis C (viral) infection
- Treats low blood count in adults suffering from severe aplastic anemia (rare blood disorder caused due to bone marrow failure to produce new blood cells)
HOW REVOLADE 50MG TABLET WORKS
REVOLADE 50MG TABLET works by binding and activating thrombopoietin receptor protein (molecules responsible for regulating platelet production) which helps in activating the pathways within the cells to increase production and development of bone marrow progenitor cells (membrane bound units responsible for producing all types of cell in bone marrow) which results in increased production of platelet cells in patients affected with immune thrombocytopenia bleeding disorder associated with/without hepatitis C or severe aplastic anemia.
DIRECTIONS FOR USE
Take REVOLADE 50MG 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.
SIDE EFFECTS OF REVOLADE 50MG TABLET
COMMON
- common cold, cough, cold sore, irritation/infection and swelling of sinus/tonsils, itchy/runny/blocked nose, bleeding nose, nasal congestion/sneezing
- loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation, bloating, gas
- infection in the nose, sinuses, throat, and upper airways
- back pain, bone pain, ear pain, nose/throat pain, toothache
- muscle pain/spasm/weakness
- heavy menstrual period
- sore throat and discomfort while swallowing
- eye problems including dry eye, cataract, spots/deposits in eye, yellowing of white of eye, itchy eye, blurred vision, and/or eye pain
- flu (influenza), pneumonia, infection of lungs, nose, and throat
- mouth problems (including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers, blisters in mouth), inflammation of gum tissue
- tingling/prickling/numbness sensation
- decreased skin sensations
- signs of blood clot in deep vein such as pain, swelling, and tenderness in one of your legs
- hematoma (localized swelling filled with blood due to break in blood vessel)
- hot flushes
- toothache
- skin changes including excessive sweating, itching bumpy rash, red spots, and/or changes in appearance of the skin
- hair loss
- signs of proteinuria (protein in urine) such as foamy, frothy, or bubbly-looking urine
- high temperature, feeling hot
- weakness, dizziness, drowsiness, tiredness, fever, chills, general discomfort
- swelling in hands/feet
- sleeping problems, anxiety, depression, migraine (headache)
- decreased vision
- spinning sensation (vertigo)
- gas
UNCOMMON
- allergic reaction
- interruption of blood to supply to parts of heart
- signs of blood clot in lungs such as sudden shortness of breath, sharp pain in chest, and/or rapid breathing
- blockade in lung artery
- signs of blood clot in a vein such as possible pain, swelling, and/or redness around a vein
- blockage in the bile tract (yellowing of the skin and/or abdominal pain)
- liver damage
- liver injury
- signs of disorder related to the heart and the blood vessels such as heart beating faster, irregular heartbeat, bluish discoloration of the skin, and/or disturbances of heart rhythm
- gout
- mood changes, lack of interest, crying at unexpected times, problems with balance, speech and nerve function, shaking
- painful/abnormal skin sensations
- paralysis on one side of the body
- nerve damage
- dilation/swelling of blood vessels that cause headache
- eye problems such as bleeding of retina
- digestive system problems including frequent bowel movements, food poisoning, blood in stool, vomiting of blood
- rectal bleeding
- sunburn
- redness/swelling around a wound
- bleeding around a catheter (if present) into the skin
- sensation of a foreign body
- signs of kidney problems such as inflammation of the kidney, excessive urination at night, and/or kidney failure
- changes in the shape of the red blood cells
- infection of the skin
- skin changes including skin discoloration, peeling, redness, itching, and/or sweating
- cancer of the rectum and colon
RARE
Stop taking REVOLADE 50MG TABLET and contact your doctor immediately if you experience any of the following side effects:
- signs of blood clot such as swelling/pain/tenderness in one leg, sudden shortness of breath (associated with sharp pain in the chest), rapid breathing, stomach pain, enlarged abdomen, and/or blood in stools
- signs of liver problems such as yellowing of skin/ whites of the eyes (jaundice), dark-colored urine
- signs of bleeding in the digestive system such as vomiting blood, black tarry stools, and/or blood in stools
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Take REVOLADE 50MG TABLET with/just after a meal. Stick to simple meals. Avoid eating oil rich/spicy foods, sugary snacks and drinks. Avoid drinking too much liquid along with your meals, and drink slowly in between meals. Consult your doctor if the condition worsens.
Diarrhoea:
Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to treat diarrhea. Consult and inform your doctor if the symptom worsens.
Constipation:
Try to eat high-fiber foods such as vegetables, cereals, fresh fruit, and drink plenty of water. Involve in regular exercise (such as going for a daily walk/ running) and if this does not help, consult and inform your doctor for receiving alternate treatments for constipation.
Dizziness:
Try to rest and get enough sleep. Try to avoid driving or operating any tools or machines while you feel dizzy. Limit consumption of alcohol, as it can aggravate dizziness. Consult and inform your doctor if the symptom worsens.
Headache:
If REVOLADE 50MG TABLET causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking REVOLADE 50MG TABLET. If it lasts more than a week or becomes severe, then consult and inform your doctor.
Tiredness:
Make sure you take rest and drink plenty of fluids. Avoid/limit the consumption of alcohol. Try to take REVOLADE 50MG TABLET at a time when you can sit down (or lie down) when the symptoms are at their worst. Avoid driving or using tools or machinery until you feel well.
Dry mouth:
Try to drink plenty of cold water and sip on cold unsweetened drinks and use lip balm if your lips are dry. Brush your teeth twice a day and use mouthwash. Consult and inform your doctor if the symptom gets worse.
WARNING & PRECAUTIONS
PREGNANCY
REVOLADE 50MG TABLET is generally not recommended for use during pregnancy unless it is clearly necessary. Women of childbearing potential should use effective contraceptive measures while in treatment with REVOLADE 50MG TABLET. Consult your doctor before taking the medicine.
BREASTFEEDING
REVOLADE 50MG TABLET is not recommended for use in breastfeeding women since it is not known whether the medicine may pass through breastmilk. Consult your doctor before taking the medicine.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy or less alert after taking REVOLADE 50MG TABLET.
KIDNEY
REVOLADE 50MG TABLET should be taken with caution in patients with kidney problems such as renal impairment. Consult your doctor before taking REVOLADE 50MG TABLET.
LIVER
REVOLADE 50MG TABLET should be used with caution in patients suffering from advanced chronic liver disease only if necessary, since the medicine may increase the risk of occurrence of side effects/blood clot. Consult your doctor before taking REVOLADE 50MG TABLET.
ALLERGY
Do not take REVOLADE 50MG TABLET if you are allergic to Eltrombopag, and/or any other ingredients of this medicine.
OTHERS
Before taking REVOLADE 50MG TABLET, inform your doctor if you:
- are at a risk of developing blood clot in veins/arteries
- are suffering from cancer
- recently undergone surgery
- had a physical injury
- are obese
- are a smoker
- have cataract (eye lens getting cloudy)
- suffer from another blood condition such as s myelodysplastic syndrome
Use in Pediatrics:
REVOLADE 50MG TABLET is not recommended for use in children (aged below 1-year) suffering from immune thrombocytopenia (platelet disorder). It is also not recommended for use in children (aged below 18 years) suffering from low platelet counts due to hepatitis C/severe aplastic anemia. Consult your doctor before taking REVOLADE 50MG TABLET.
Use in Geriatrics:
REVOLADE 50MG TABLET should be used with caution in elderly patients (aged 65-years/above). Consult your doctor before taking REVOLADE 50MG TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking REVOLADE 50MG TABLET inform your doctor if you are taking any of the following medicine:
- a blood thinner
- antacids (used in indigestion, stomach ulcers/heartburn) Ex. aluminum hydroxide, magnesium carbonate
- statins (used to treat high cholesterol) Ex. atorvastatin, fluvastatin
- lopinavir, ritonavir (medicines used to treat HIV)
- ciclosporin (used to prevent rejection of transplanted organ)
- vitamins and mineral supplements such as iron, calcium, aluminum, magnesium, selenium, and zinc
- methotrexate, topotecan (medicines used to treat cancer)
- corticosteroids (used to provide relief from inflammation) Ex. cortisone, hydrocortisone
- danazol (used to treat endometriosis)
- azathioprine (used for inflammatory conditions)
B. Drug-food interaction:
Avoid taking REVOLADE 50MG TABLET with dairy foods/drinks since calcium in dairy products may affect the absorption of the medicine and alter its effect.
Overdosage:
If you or anyone else accidentally take too much of REVOLADE 50MG TABLET, consult your doctor immediately or visit the nearby hospital to manage overdose symptoms.
SYNOPSIS
| Drug | : | Eltrombopag |
| Pharmacological Category | : | Thrombopoietin-receptor agonist |
| Therapeutic Indication | : | Immune thrombocytopenia, thrombocytopenia with hepatitis C virus infection/aplastic anemia |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep REVOLADE 50MG TABLET out of reach of children
- Store REVOLADE 50MG TABLET at room temperature
FAQs ABOUT REVOLADE 50MG TABLET
What is REVOLADE 50MG TABLET used for?
REVOLADE 50MG TABLET is used to treat immune thrombocytopenia (platelet disorder) in patients aged 1-year/above when other medicines (such as corticosteroids/immunoglobulins) become ineffective to treat the disease. It is also used to treat thrombocytopenia (low platelet count) in adults suffering from hepatitis C (viral) infection and/or severe aplastic anemia (rare blood disorder) in affected individuals.
What are the common side effects of taking REVOLADE 50MG TABLET?
The most common side effects of taking REVOLADE 50MG TABLET are common cold, cough, nausea, vomiting, diarrhea, constipation, and/or hair loss. Consult your doctor if any of these symptoms worsens.
How REVOLADE 50MG TABLET works?
REVOLADE 50MG TABLET works by binding and activating thrombopoietin receptor protein (molecules responsible for regulating platelet production) which helps in activating the pathways within the cells to increase production and development of bone marrow progenitor cells (membrane bound units responsible for producing all types of cell in bone marrow) which results in increased production of platelet cells in patients affected with immune thrombocytopenia bleeding disorder associated with/without hepatitis C or severe aplastic anemia.
How REVOLADE 50MG TABLET should be taken?
Take REVOLADE 50MG TABLET as advised by your physician. Swallow the medicines with a glass of water. Do not crush or chew the medicine. Your physician will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
Can REVOLADE 50MG TABLET be used in pregnant women?
REVOLADE 50MG TABLET is generally not recommended for use during pregnancy unless it is clearly necessary. Women of childbearing potential should use effective contraceptive measures while in treatment with REVOLADE 50MG TABLET. Consult your doctor before taking the medicine.
REFERENCES
1. Kenneth Kaushansky and Thomas J. Kipps. Hematopoietic Agents: Growth Factors, Minerals, and Vitamins. Hematopoietic Agents: Growth Factors, Minerals, and Vitamins. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. New York McGraw Hill Medical 2018 Page – 751-767.
2. Thomas Kühne, Paul Imbach. Eltrombopag: an update on the novel, non-peptide thrombopoietin receptor agonist for the treatment of immune thrombocytopenia. Annals of Hematology. Springer Link. April 2010. [Accessed on 11th May 2022] https://link.springer.com/article/10.1007/s00277-010-0953-x
3. John W Bauman, Carolyn T Vincent, Bin Peng, Mary B Wire, Daphne D Williams, Jung Wook Park. Effect of hepatic or renal impairment on eltrombopag pharmacokinetics. NIH National Library of Medicine. National Center for Biotechnology Information. PubMed.gov. May 2011. [Accessed on 11th May 2022] https://pubmed.ncbi.nlm.nih.gov/20663991/
4. Novartis Pharmaceuticals UK Limited. Electronic Medicines Compendium (EMC). [Revised in January 2022] [Accessed on 11th May 2022] https://www.medicines.org.uk/emc/files/pil.7819.pdf
USEFUL DIAGNOSTIC TESTS
- Blood smear test
AUTHOR DETAILS
Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 19 Dec 2022 | 05:48 PM(IST)
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