Trombola 50 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Eltrombopag olamine |
| Company | Ziska pharmaceuticals ltd |
| Also available as |
Indications
- Treatment of thrombocytopenia in patients with persistent or chronic immune thrombocytopenia
- Treatment of thrombocytopenia in patients with hepatitis C infection
- Treatment of severe aplastic anemia
Pharmacology
Eltrombopag Olamine is a small molecule thrombopoietin (TPO) receptor agonist. It interacts with the transmembrane domain of the human TPO-receptor and induces signaling cascades that lead to increased platelet production.
Dosage & Administration
- Route of administration: Oral
- Administration with meal:
- Can be taken without a meal
- Can be taken with a meal low in calcium (<50 mg)
- Dosage for different conditions:
- Persistent or chronic immune thrombocytopenia:
- Dosage: Use the lowest dose to achieve and maintain a platelet count greater than or equal to 50x10^9/L
- Maximum daily dose: 75 mg
- Adult and pediatric patients with ITP: Initiate at 50 mg once daily, with adjustments for Asian ancestry or hepatic impairment
- Pediatric patients with ITP aged 1 to 5 years: Initiate at 25 mg once daily
- Chronic hepatitis C associated thrombocytopenia: Initiate at 25 mg once daily, with dose adjustments to achieve target platelet count
- First line severe aplastic anemia: Initiate at specific doses based on age and hepatic impairment, with dose modifications based on platelet counts and liver enzymes
- Refractory severe aplastic anemia: Initiate at 50 mg once daily, with dose titration and adjustments to achieve target platelet count
- Persistent or chronic immune thrombocytopenia:
Interaction
- Drug interaction with medication: Take eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids and mineral supplements
- Drug interaction with food and others: Take eltrombopag at least 2 hours before or 4 hours after any calcium rich foods
Contraindications
Eltrombopag is contraindicated in patients with known hypersensitivity to eltrombopag or any components of this product
Side Effects
- Anemia
- Nausea
- Pyrexia
- ALT increased
- Cough
- Fatigue
- Headache
- Diarrhea
Pregnancy & Lactation
No sufficient data is available to assess any drug-associated risks for major birth defects, miscarriage or adverse maternal or fetal outcomes. Breastfeeding is not recommended during treatment.
Precautions & Warnings
In patients with chronic hepatitis C, Trombola in combination with interferon and ribavirin may increase the risk of hepatic decompensation. Monitor liver function before and during therapy. There is an increased risk of death and progression of myelodysplastic syndromes to acute myeloid leukemia.
Use in Special Populations
Safety and efficacy in pediatric patients below the age of 1 year with ITP have not been established.
Overdose Effects
In the event of overdose, platelet counts may increase excessively and result in thrombotic or thromboembolic complications. Consider oral administration of a metal cation containing preparation to limit absorption.
Therapeutic Class
Haemostatic drugs
Storage Conditions
Store in a cool (below 25°C) and dry place protected from light. Keep away from the reach of children.