a) Eltrombopag Tablets 12.5mg
b) Eltrombopag Tablets 25mg
c) Eltrombopag Tablets 50mg
d) Eltrombopag Tablets 75mg
e) Eltrombopag Tablets 100mg
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- Eltrombopag Tablets 50mg
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GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Eltrombopag Tablets 12.5mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...12.5mg
Excipients…………………q.s.
Colours: Titanium Dioxide
b) Eltrombopag Tablets 25mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...25mg
Excipients…………………q.s.
Colours: Iron Oxide Red
c) Eltrombopag Tablets 50mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...50mg
Excipients…………………q.s.
Colours: Iron Oxide Yellow
d) Eltrombopag Tablets 75mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...75mg
Excipients…………………q.s.
Colours: Iron Oxide Black
e) Eltrombopag Tablets 100mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...100mg
Excipients…………………q.s.
Colours: Brilliant Blue FCF
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...12.5mg
Excipients…………………q.s.
Colours: Titanium Dioxide
b) Eltrombopag Tablets 25mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...25mg
Excipients…………………q.s.
Colours: Iron Oxide Red
c) Eltrombopag Tablets 50mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...50mg
Excipients…………………q.s.
Colours: Iron Oxide Yellow
d) Eltrombopag Tablets 75mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...75mg
Excipients…………………q.s.
Colours: Iron Oxide Black
e) Eltrombopag Tablets 100mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag …………...100mg
Excipients…………………q.s.
Colours: Brilliant Blue FCF
THERAPEUTIC INDICATIONS:
Eltrombopag is used to treat chronic immune thrombocytopenia (ITP). ITP is a condition in which platelets are destroyed by the immune system.
CAUTION & WARNING:
Caution: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of Haematologist or Doctor of Medicine or oncologist only.
Federal Law requires dispensing of Eltrombopag Tablets with the Medication Guide provided with it.
Do not use if printed safety seal under cap is broken or missing.
Important: Use safety closures when dispensing these products unless otherwise directed by physicians or requested by purchasers.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of Haematologist or Doctor of Medicine or oncologist only.
Federal Law requires dispensing of Eltrombopag Tablets with the Medication Guide provided with it.
Do not use if printed safety seal under cap is broken or missing.
Important: Use safety closures when dispensing these products unless otherwise directed by physicians or requested by purchasers.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Do not remove desiccant.
Dosage: As directed by the Hematologist or Doctor of Medicine or Oncologist only.
For Oral use. Read the package insert before use.
Dosage: As directed by the Hematologist or Doctor of Medicine or Oncologist only.
For Oral use. Read the package insert before use.
Eltrombopag Tablets 50mg Technical Specification:
| Product Name: | Eltrombopag Tablets 50mg |
| Brand Name: | Eltrombopag |
| Strength: | 12.5mg, 25mg, 50mg, 75mg, 100mg |
| Dosage Form: | Film-coated Tablet |
| Packing: | 7s, 28s, 30s |
| Route of Administration: | For Oral Use only. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Cancer |
| Indication: | Eltrombopag is used to treat chronic immune thrombocytopenia (ITP). ITP is a condition in which platelets are destroyed by the immune system. |
| Storage: | Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Do not remove desiccant. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Eltrombopag Tablets 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Eltrombopag Tablets 50mg
Each film-coated tablet contains:
Eltrombopag Olanine equivalent to
Eltrombopag ……………50mg
Excipients…………………q.s.
Colours: Iron Oxide Yellow
THERAPEUTIC INDICATIONS:
Eltrombopag is used to treat chronic immune thrombocytopenia (ITP). ITP is a condition in which platelets are destroyed by the immune system.
CAUTION & WARNING:
Caution: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of Haematologist or Doctor of Medicine or oncologist only.
Federal Law requires dispensing of Eltrombopag Tablets with the Medication Guide provided with it.
Do not use if printed safety seal under cap is broken or missing.
Important: Use safety closures when dispensing these products unless otherwise directed by physicians or requested by purchasers.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Do not remove desiccant.
Dosage: As directed by the Hematologist or Doctor of Medicine or Oncologist only.
For Oral use. Read the package insert before use.
Frequently Asked Questions (FAQs) – Eltrombopag 50mg Tablet
1. What is Eltrombopag 50mg Tablet used for?
Eltrombopag 50mg is primarily used for treating:
Chronic Immune Thrombocytopenia (ITP) in adults and children who have not responded to other treatments (e.g., corticosteroids, immunoglobulins).
Aplastic anemia that is severe and unresponsive to immunosuppressive therapy.
Thrombocytopenia in chronic Hepatitis C patients to allow them to initiate or continue interferon-based therapy.
2. How does Eltrombopag work in the body?
Eltrombopag is a thrombopoietin receptor agonist. It stimulates the TPO receptors on bone marrow cells, encouraging the production of platelets, which helps reduce the risk of bleeding in patients with low platelet counts.
3. Is Eltrombopag 50mg a steroid?
No, Eltrombopag is not a steroid. It is a non-peptide small molecule that activates the thrombopoietin receptor to increase platelet production.
4. How should I take Eltrombopag 50mg Tablet?
Take exactly as prescribed by your healthcare provider.
Swallow the tablet with water, usually once daily.
Do not consume dairy products, antacids, or mineral supplements (containing calcium, iron, magnesium, aluminum) within 4 hours of taking the medication, as they can interfere with absorption.
5. Can Eltrombopag cure thrombocytopenia?
Eltrombopag does not cure thrombocytopenia but helps manage the condition by increasing platelet counts and reducing bleeding risk. It is a chronic therapy in many patients.
6. What are the common side effects of Eltrombopag?
Common side effects include:
Headache
Nausea
Diarrhea
Fatigue
Liver function abnormalities (elevated liver enzymes)
Risk of clotting (thromboembolism) in rare cases
Always consult your doctor for any unusual symptoms.
7. Is monitoring required during Eltrombopag treatment?
Yes, regular blood tests are essential:
Platelet counts
Liver function tests (LFTs)
Complete blood count (CBC)
Monitoring helps adjust the dose and detect any adverse reactions early.
8. Can I take Eltrombopag if I have liver problems?
Caution is advised. Eltrombopag is metabolized in the liver, and patients with liver impairment must be closely monitored. Dose adjustments may be required.
9. Is Eltrombopag 50mg Tablet safe during pregnancy or breastfeeding?
There is limited human data on Eltrombopag use during pregnancy or lactation. It should only be used if the benefits outweigh the risks. Pregnant or breastfeeding women must consult their healthcare provider.
10. How should Eltrombopag be stored?
Store at room temperature below 30°C.
Keep in a dry place, away from direct sunlight and moisture.
Keep out of reach of children.
11. What should I do if I miss a dose?
Take the missed dose as soon as you remember.
If it’s almost time for your next dose, skip the missed dose and continue with your regular schedule.
Do not double the dose to make up for a missed one.
12. Can Eltrombopag be taken long-term?
Yes, in many cases, long-term treatment is required, especially in chronic ITP or aplastic anemia. However, treatment duration is determined by your healthcare provider based on response and tolerance.
13. Is a prescription required for Eltrombopag?
Yes, Eltrombopag is a prescription-only medication. It must be used under the guidance and supervision of a qualified healthcare professional.
14. What is the cost of Eltrombopag 50mg in India?
The cost may vary depending on the manufacturer, location, and packaging, but direct manufacturer supply (like from Taj Pharmaceuticals) offers high-quality Eltrombopag at competitive prices.
15. Can I order Eltrombopag 50mg in bulk or for institutional supply?
Yes, Taj Pharmaceuticals offers bulk supply, PCD franchise partnerships, and institutional procurement options across India and internationally.
