a) Eltrombopag Tablets 12.5mg
b) Eltrombopag Tablets 25mg
c) Eltrombopag Tablets 50mg
d) Eltrombopag Tablets 75mg
e) Eltrombopag Tablets 100mg
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 100mg Technical Specification:
| Product Name: | Eltrombopag Tablets 100mg |
| 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 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- 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.
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 100mg Tablet
1. What is Eltrombopag 100mg Tablet used for?
Eltrombopag 100mg Tablet is primarily used to treat:
Chronic immune thrombocytopenia (ITP) in patients who have not responded to other treatments.
Thrombocytopenia in patients with chronic hepatitis C, allowing for the initiation and maintenance of interferon-based therapy.
Severe aplastic anemia (SAA) in adults who have had an insufficient response to immunosuppressive therapy.
2. How does Eltrombopag work in the body?
Eltrombopag is a thrombopoietin receptor agonist that stimulates the bone marrow to produce more platelets. It binds to and activates the thrombopoietin receptor (TPO-R) on bone marrow progenitor cells, promoting platelet production and reducing the risk of bleeding.
3. Who manufactures Eltrombopag 100mg Tablets in India?
In India, several reputable pharmaceutical companies manufacture Eltrombopag 100mg Tablets, including Taj Pharmaceuticals. The company is known for its WHO-GMP certified facilities and PAN India distribution, including Mumbai and Vapi, Gujarat.
4. Is Eltrombopag a steroid?
No, Eltrombopag is not a steroid. It belongs to a class of medications called thrombopoietin receptor agonists, which specifically target platelet production mechanisms in the body, unlike steroids that work by suppressing the immune system.
5. What are the side effects of Eltrombopag Tablets?
Common side effects include:
Nausea
Headache
Fatigue
Diarrhea
Increased liver enzymes
Rare but serious side effects may include hepatotoxicity, thrombotic complications, and cataracts. Regular monitoring is recommended during treatment.
6. What is the recommended dosage for Eltrombopag 100mg Tablet?
The dosage depends on the indication, patient’s weight, liver function, and platelet count. Typically, the starting dose for adults ranges from 25mg to 50mg once daily, adjusted based on response. A 100mg dose is used in select cases under strict medical supervision.
Always follow your physician’s prescribed dosage.
7. Can Eltrombopag Tablet be taken with food?
Yes, but it is best taken on an empty stomach or with low-calcium foods. Foods high in calcium (like dairy products) may reduce the drug’s absorption. It is advised to avoid antacids and supplements containing calcium, aluminum, magnesium, or iron within 4 hours of taking the tablet.
8. How should Eltrombopag Tablets be stored?
Store the tablets:
At room temperature (below 30°C)
In a cool, dry place
Away from direct sunlight and moisture
Out of reach of children
9. Are there any drug interactions with Eltrombopag?
Yes. Eltrombopag may interact with:
Antacids or supplements containing divalent cations (calcium, magnesium, iron, aluminum)
Certain antibiotics like ciprofloxacin
Drugs metabolized through the CYP1A2 or CYP2C8 enzymes
Always inform your doctor about any other medications or supplements you are taking.
10. Is Eltrombopag safe during pregnancy or breastfeeding?
There is limited data on the use of Eltrombopag during pregnancy. It should only be used if the potential benefits outweigh the risks. It is not recommended during breastfeeding, as it is unknown whether the drug passes into breast milk.
11. Can Eltrombopag cure ITP or SAA?
Eltrombopag is not a cure. It helps to manage platelet counts effectively and improve quality of life. In some cases, platelet levels may normalize, but long-term treatment or monitoring may be necessary.
12. How can I buy Eltrombopag Tablets in India at the best price?
Eltrombopag 100mg Tablets are available at competitive prices through reputed manufacturers and suppliers like Taj Pharmaceuticals. They offer bulk supply, institutional orders, and PCD Pharma Franchise options PAN India.
13. Can I export Eltrombopag 100mg Tablets from India?
Yes, several manufacturers including Taj Pharmaceuticals offer export-quality Eltrombopag Tablets compliant with WHO-GMP, USFDA, and other international regulatory standards. Export support includes custom labeling, product registration documents, and fast logistics.
14. How can I become a PCD Pharma Franchise partner for Eltrombopag Tablets?
You can apply through the manufacturer’s official contact channels. Requirements typically include:
A valid drug license
Experience in pharma marketing
Basic investment
Coverage area (city/state)
Franchise partners receive exclusive marketing rights, promotional support, and attractive margins.
15. Is a prescription required to buy Eltrombopag Tablets?
Yes, Eltrombopag is a prescription-only medication. It should be taken under the supervision of a healthcare professional after proper diagnosis and prescription.
