Regulatory Information
ZUELLIG PHARMA PTE. LTD.
EURODRUG LABORATORIES SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION:** For oral use. EBASTINE (Kestine®) 20 mg film-coated tablets may be taken with or without food. Tablets must be swallowed whole with a small amount of water. **Adults and children over 12 years of age**– The usual dose is 10 mg of ebastine once daily, but some patients may require a dose of 20mg once daily. **Children 12 years old and below**– The safety of ebastine film-coated tablets has not been established for children under 12 years of age. **For Elderly**– not necessary to adjust dose.**For patients with Renal Impairment**– not necessary to adjust dose.**For patients with Liver Impairment**– not necessary to adjust dose but in patients with liver failure a dose of 10 mg/day should not be exceeded.
ORAL
Medical Information
**INDICATION:** EBASTINE (Kestine®) is indicated in the treatment of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis.
**CONTRAINDICATION:** Hypersensitivity to EBASTINE or any of the excipients.
R06AX22
ebastine
Manufacturer Information
EURODRUG LABORATORIES SINGAPORE PTE. LTD.
Industrias Farmaceuticas Almirall. S.A. (IFA)
Active Ingredients
Documents
Package Inserts
Kestine 20mg Film-coated Tablet PI.pdf
Approved: March 12, 2019