- Approval Id
- f791b188332a03c5
- Drug Name
- EPIDUO FORTE GEL 0.3%/2.5%
- Product Name
- EPIDUO FORTE GEL 0.3%/2.5%
- Approval Number
- SIN15460P
- Approval Date
- 2018-04-03
- Registrant
- GALDERMA SINGAPORE PRIVATE LIMITED
- Licence Holder
- GALDERMA SINGAPORE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- GEL
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
<u><strong>Recommended Dose and Dosage Adjustment</strong></u></p>
<p>EPIDUO FORTE Gel (adapalene 0.3%/benzoyl peroxide 2.5%) Gel (patients 12 years of age and older), should be applied to affected areas of the face, chest and back once daily in the evening, after washing gently with a non-medicated cleanser.</p>
<p>A small amount of EPIDUO FORTE Gel should be applied to provide a thin film, avoiding eyes, lips and mucous membranes. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin.</p>
<p>If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers. Discontinue treatment if a severe local inflammatory response is experienced. Reinstitute therapy when the reaction has subsided, initially applying the preparation less frequently (e.g. every other day). Once-daily application may be resumed if it is judged that the patient is able to tolerate the treatment.</p>
<p><u><strong>Missed Dose</strong></u><br>
If a single dose is missed, dosing should continue as per usual the following day, and the usual amount should be applied.</p>
- Route Of Administration
- TOPICAL
- Indication Info
- <p><strong>INDICATIONS AND CLINICAL USE</strong><br>
EPIDUO FORTE Gel (adapalene 0.3%/benzoyl peroxide 2.5%) is indicated for:</p>
<ul>
<li>Treatment of acne vulgaris, characterized by comedones, inflammatory papules/pustules with or without occasional nodules in patients 12 years of age and older. (See Clinical Trials Section – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
</ul>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<ul>
<li>Patients who are hypersensitive to adapalene, benzoyl peroxide or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Application to areas of skin affected by eczema or seborrhoeic dermatitis</li>
<li>Pregnancy</li>
<li>Women planning a pregnancy</li>
</ul>
- Atc Code
- D10AD53
- Atc Item Name
- adapalene, combinations
- Pharma Manufacturer Name
- GALDERMA SINGAPORE PRIVATE LIMITED
- Company Detail Path
- /organization/galderma-singapore-private-limited
