Eltrombopag Tablets 25mg
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Eltrombopag Tablets 25mg Technical Specification

Product Name: Eltrombopag Tablets 25mg
Brand Name: Generic
Strength: (25mg), (50mg)
Dosage Form: Tablets (Film-coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Blood Products
Indication: Eltrombopag is an orally bioavailable thrombopoietin-receptor (TPO) agonist. It received FDA approval for use in chronic idiopathic (immune) thrombocytopenia purpura (ITP) in those who have had an insufficient response to corticosteroids, immune globulin, or splenectomy
Storage: Store at 20° to 25°C (68° to 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Eltrombopag Tablets 25mg
    Each Film-coated tablet contains:
    Eltrombopag Olamine
    Eq. to Eltrombopag as a free acid …………….25mg
    Excipients…………………………………………………..q.s.
    Color: Titanium Dioxide USP
  • Eltrombopag Tablets 50mg
    Each Film-coated tablet contains:
    Eltrombopag Olamine
    Eq. to Eltrombopag as a free acid …………….50mg
    Excipients…………………………………………………..q.s.
    Color: Ferric Oxide of Red USP-NF

THERAPEUTIC INDICATIONS:

Eltrombopag is an orally bioavailable thrombopoietin-receptor (TPO) agonist. It received FDA approval for use in chronic idiopathic (immune) thrombocytopenia purpura (ITP) in those who have had an insufficient response to corticosteroids, immune globulin, or splenectomy

CAUTION & WARNING:

CAUTION:  Read enclosed leaflet before use.

Keep medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning:  To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:  Store at 20° to 25°C (68° to 77°F).

Dosage: As directed by the hematologist Doctor of medicine or Oncologist.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Eltrombopag Tablets 25mg
B) Eltrombopag Tablets 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Eltrombopag Tablets 25mg
Each Film-coated tablet contains:
Eltrombopag Olamine
Eq. to Eltrombopag as a free acid …………….25mg
Excipients…………………………………………………..q.s.
Color: Titanium Dioxide USP

B) Eltrombopag Tablets 50mg
Each Film-coated tablet contains:
Eltrombopag Olamine
Eq. to Eltrombopag as a free acid …………….50mg
Excipients…………………………………………………..q.s.
Color: Ferric Oxide of Red USP-NF

THERAPEUTIC INDICATIONS:

Eltrombopag is an orally bioavailable thrombopoietin-receptor (TPO) agonist. It received FDA-approval for use in chronic idiopathic (immune) thrombocytopenia purpura (ITP) in those who have had insufficient response to corticosteroids, immune globulin or splenectomy

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the hematologist Doctor of medicine or Oncologist.