Eltrombopag Tablets 25mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Eltrombopag Tablets 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Eltrombopag Tablets 25mg
  Each film-coated tablet contains:
  Eltrombopag Olanine equivalent to
  Eltrombopag ……………25mg
  Excipients…………………q.s.
  Colours: Iron Oxide Red

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) for Eltrombopag 25mg Tablet

Eltrombopag 25mg Tablet is a prescription medication used primarily to increase platelet counts in specific medical conditions. Manufactured under stringent quality protocols by Taj Pharmaceuticals, this medication is widely trusted across India and global markets. Below are the most frequently asked questions by patients, caregivers, and healthcare professionals regarding Eltrombopag 25mg Tablet.

1. What is Eltrombopag 25mg Tablet used for?

Eltrombopag 25mg Tablet is primarily used to treat:

• Chronic Immune Thrombocytopenia (ITP) in adults and children who have not responded to other treatments like corticosteroids or immunoglobulins.

• Thrombocytopenia in Hepatitis C Virus (HCV) patients to allow for the initiation and maintenance of interferon-based therapy.

• Severe Aplastic Anemia (SAA) in patients who are unresponsive to immunosuppressive therapy.

2. How does Eltrombopag work in the body?

Eltrombopag works by stimulating the thrombopoietin receptor (TPO-R), which increases the production of platelets from the bone marrow. It mimics the action of natural thrombopoietin, a hormone involved in platelet production.

3. What is the recommended dosage of Eltrombopag 25mg Tablet?

The dosage varies based on the medical condition and individual patient response:

• For ITP: Adults typically start with 50 mg once daily; dose adjustments are made based on platelet count. Pediatric doses may begin at 25 mg daily.

• For Hepatitis C-related thrombocytopenia: Typically initiated at 25 mg once daily.

• For Severe Aplastic Anemia: Doses may start at 50 mg once daily and are adjusted based on platelet response and liver function.

Note: Dosage must be personalized under a healthcare provider’s supervision.

4. How should I take Eltrombopag 25mg Tablet?

• Take the tablet exactly as prescribed.

• Take on an empty stomach, at least 1 hour before or 2 hours after meals.

• Avoid taking it with dairy products, antacids, or mineral supplements that contain calcium, magnesium, aluminum, iron, or zinc, as these can interfere with absorption.

5. What are the possible side effects of Eltrombopag 25mg Tablet?

Common side effects may include:

• Headache

• Nausea

• Fatigue

• Diarrhea

• Upper respiratory tract infections

Serious side effects can include:

• Liver toxicity (elevated liver enzymes)

• Thrombotic complications (blood clots)

• Cataract formation (long-term use)

Always report any unusual symptoms to your doctor immediately.

6. Can Eltrombopag cure ITP or aplastic anemia?

No, Eltrombopag does not cure these conditions. It helps manage platelet levels to reduce the risk of bleeding. The underlying condition may persist and require ongoing treatment or monitoring.

7. Is Eltrombopag a steroid or chemotherapy drug?

No, Eltrombopag is not a steroid or a chemotherapy agent. It is a thrombopoietin receptor agonist (TPO-RA) designed specifically to stimulate platelet production in the bone marrow.

8. What precautions should I take while on Eltrombopag?

• Regular blood tests are necessary to monitor platelet levels and liver function.

• Avoid alcohol to reduce liver stress.

• Inform your doctor about all current medications, supplements, and pre-existing health conditions.

• Avoid high-risk activities that may cause bleeding or bruising.

9. Can Eltrombopag be taken during pregnancy or breastfeeding?

Eltrombopag is not recommended during pregnancy or breastfeeding, unless clearly necessary and prescribed by a physician. Its safety profile in pregnant women and nursing infants is not well established.

10. What should I do if I miss a dose?

If you miss a dose:

• Take it as soon as you remember, unless it’s near the time for the next dose.

• Do not double the dose to catch up.

• Maintain a consistent daily schedule to avoid missing doses.

11. Can I stop taking Eltrombopag suddenly?

Do not stop taking Eltrombopag abruptly without consulting your doctor. Sudden discontinuation can lead to a dangerous drop in platelet count, increasing the risk of severe bleeding.

12. Where can I buy Eltrombopag 25mg Tablet in India?

Eltrombopag 25mg Tablet is manufactured and supplied by Taj Pharmaceuticals Ltd., headquartered in Vapi, Gujarat with supply across Mumbai, Maharashtra, and PAN India. It is available through:

• Authorized medical stores

• Hospital pharmacies

• Online pharmacies with a valid prescription

• PCD Pharma Franchise and Distributor Network

13. Is Eltrombopag available for export outside India?

Yes, Taj Pharmaceuticals is a global exporter of Eltrombopag Tablets, supplying to markets across:

• Africa

• Middle East

• Southeast Asia

• Latin America

• CIS countries

We offer custom packaging, documentation, and regulatory support for international buyers and institutions.

14. Can Eltrombopag be used in children?

Yes, Eltrombopag is approved for pediatric use in children over the age of 1 year with chronic ITP, but only under specialist supervision. Dosage varies depending on age, weight, and clinical condition.

15. Is Eltrombopag safe for long-term use?

Eltrombopag can be used long-term under strict medical monitoring. Prolonged use requires regular checks for liver function, eye health (for cataracts), and thrombotic risks.