KESTINE TABLET 10 MG [SIN09435P]
Active ingredients: KESTINE TABLET 10 MG
Product Info
KESTINE TABLET 10 MG
[SIN09435P]
Product information
Active Ingredient and Strength | EBASTINE - 10 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | INDUSTRIAS FARMACEUTICAS ALMIRALL (IFA) S.A. - SPAIN |
Registration Number | SIN09435P |
Licence Holder | EURODRUG LABORATORIES SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | R06AX22 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
INDICATION:
10mg: Ebastine (Kestine®) is indicated in the treatment of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis and chronic idiopathic urticaria.
20mg: Ebastine (Kestine®) is indicated in the treatment of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis.
Dosing
DOSAGE AND ADMINISTRATION:
For oral use. Ebastine (Kestine®) 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:
10mg:
Allergic Rhinitis: The usual dose is 10 mg of ebastine once daily. In the event of severe symptoms, the dose may be increased to 20 mg once daily.
Chronic Idiopathic Urticaria: A dose of 10 mg once daily.
20mg:
Allergic Rhinitis: The usual dose is 10 mg of ebastine once daily. In the event of severe symptoms, the dose may be increased to 20 mg once daily.
Children 12 years old and below
The safety of Ebastine (Kestine®) 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 hepatic impairment
not necessary to adjust dose in patients with mild to moderate hepatic impairment. There is no experience with doses greater than 10 mg in patients with severe hepatic impairment.
Therefore, the 10 mg dose should not be exceeded in patients with severe hepatic impairment.
Contraindications
CONTRAINDICATION:
Children under 12 due to a lack of efficacy and safety data
History of hypersensitivity to the active substance or to any of the excipients.
