- Approval Id
- 25084a89a4ef4c83
- Drug Name
- CLINDOXYL ONCE DAILY GEL
- Product Name
- CLINDOXYL ONCE DAILY GEL
- Approval Number
- SIN13332P
- Approval Date
- 2007-08-07
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- GEL
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><strong>Adults and Adolescents</strong></p>
<p>Clindoxyl® Once Daily Gel is for topical use only.</p>
<p>Clindoxyl® Once Daily Gel should be applied in a thin film over entire affected area once daily after washing gently with a mild cleanser and fully drying.</p>
<p>If the gel does not rub into the skin easily, too much is being applied.</p>
<p>Hands should be washed after application. Patients may also use a moisturiser as needed.</p>
<p>Two to five weeks of treatment may be required before a therapeutic effect is observed (<em>see Clinical Studies</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The safety and efficacy of clindamycin/benzoyl peroxide have not been studied beyond 12 weeks in acne vulgaris clinical trials. The prescriber should evaluate the benefit of continuing treatment beyond 12 weeks of uninterrupted use.</p>
<p><strong>Children</strong></p>
<p>The safety and efficacy of Clindoxyl® Once Daily Gel have not been established in children less than 12 years of age, therefore clindamycin/benzoyl peroxide is not recommended for use in this population.</p>
<p><strong>Elderly</strong></p>
<p>There are no specific recommendations for use in the elderly.</p>
- Route Of Administration
- TOPICAL
- Indication Info
- <p><strong>Indications</strong></p>
<p>Clindoxyl® Once Daily Gel is indicated for the topical treatment of mild to moderate acne vulgaris.</p>
<p>Clindoxyl® Once Daily Gel has not been demonstrated to have any additional benefit when compared to benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Clindoxyl® Once Daily Gel is contraindicated in:</p>
<ul>
<li><p>patients who have demonstrated hypersensitivity to lincomycin, clindamycin, benzoyl peroxide or any components of the formulation.</p></li>
<li><p>patients with, or with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis).</p></li>
</ul>
- Atc Code
- D10AF51
- Atc Item Name
- clindamycin, combinations
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
