- Approval Id
- 2b41fbf53481674f
- Drug Name
- KESTINE FILM-COATED TABLET 20MG
- Product Name
- KESTINE FILM-COATED TABLET 20MG
- Approval Number
- SIN15644P
- Approval Date
- 2019-03-12
- Registrant
- EURODRUG LABORATORIES SINGAPORE PTE. LTD.
- Licence Holder
- EURODRUG LABORATORIES SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION:</strong><br>
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.</p>
<p><strong>Adults and children over 12 years of age:</strong></p>
<p><strong>10mg:</strong></p>
<ul class="dash">
<li><u>Allergic Rhinitis:</u> 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.</li>
<li><u>Chronic Idiopathic Urticaria:</u> A dose of 10 mg once daily.</li>
</ul>
<p><strong>20mg:</strong></p>
<ul class="dash">
<li><u>Allergic Rhinitis:</u> 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.</li>
</ul>
<p><strong>Children 12 years old and below</strong></p>
<ul class="dash">
<li>The safety of Ebastine (Kestine®) film-coated tablets has not been established for children under 12 years of age.</li>
</ul>
<p><strong>For elderly</strong></p>
<ul class="dash">
<li>not necessary to adjust dose.</li>
</ul>
<p><strong>For patients with renal impairment</strong></p>
<ul class="dash">
<li>not necessary to adjust dose</li>
</ul>
<p><strong>For patients with hepatic impairment</strong></p>
<ul class="dash">
<li>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.<br>
Therefore, the 10 mg dose should not be exceeded in patients with severe hepatic impairment.</li>
</ul>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATION:</strong><br>
<strong>10mg:</strong> Ebastine (Kestine®) is indicated in the treatment of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis and chronic idiopathic urticaria.<br>
<strong>20mg:</strong> Ebastine (Kestine®) is indicated in the treatment of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis.</p>
- Contraindications
- <p><strong>CONTRAINDICATION:</strong><br>
Children under 12 due to a lack of efficacy and safety data<br>
History of hypersensitivity to the active substance or to any of the excipients.</p>
- Atc Code
- R06AX22
- Atc Item Name
- ebastine
- Pharma Manufacturer Name
- EURODRUG LABORATORIES SINGAPORE PTE. LTD.
