Eltrombopag INN
Composition: Olapag 25 : Each film coated tablet contains Eltrombopag Olamine INN 25 mg.
Olapag 50 : Each film coated tablet contains
Eltrombopag Olamine INN 50 mg.
Indications : Eltrombopag is indicated for the treatment
of thrombocytopenia in adult and pediatric patients 1 year and older with
chronic immune Idiopathic Thrombocytopenia (ITP) who have had an insufficient
response to corticosteroids, immunoglobulin, or splenectomy. Eltrombopag is
indicated for the treatment of thrombocytopenia in patients with chronic
hepatitis C to allow the initiation and maintenance of interferon- based
therapy. Eltrombopag is indicated for the treatment of patients with severe
aplastic anemia who have had an insufficient response to immunosuppressive
therapy.
Dosage & Administration : Take orally on
an empty stomach ( 1 hours before or 2 hours after a meal).
Chronic ITP : Adult and
Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose
of 50 mg once daily. For Pediatric Patients with ITP Aged 1 to 5 Years:
Initiate Eltrombopag at a dose of 25 mg
once daily. Adjust to maintain platelet count greater than or equal to
50x109/L. Do not exceed 75mg per day.
Chronic
Hepatitis C-Associated Thrombocytopenia : Initiate Eltrombopag at a dose of
25 mg once daily for all patients. Adjust to achieve target platelet
count required to initiate antiviral therapy. Do not exceed a daily dose
of 100 mg.
Severe Aplastic
Anemia : Initiate
Eltrombopag at 50 mg once daily. Adjust to maintain platelet count greater than
50 x 109/L. Do not exceed 150mg per day. Or, as directed by the registered
physician.
Use in pregnancy and lactation : Pregnancy : Pregnancy
category C. Nursing mother : It is not known whether Eltrombopag
is excreted in human milk.A decision should be made whether to
discontinue nursing or to discontinue Eltrombopag taking into account
the importance of Eltrombopag to the mother.
Packing:
Olapag-25 : Each
box contains 10’s tablets in blister pack.
Olapag-50 : Each box contains 10’s tablets in blister pack.
