- Approval Id
- ed09f1759e550244
- Drug Name
- LUCONAC EXTERNAL SOLUTION FOR NAILS 5% W/W
- Product Name
- LUCONAC EXTERNAL SOLUTION FOR NAILS 5% W/W
- Approval Number
- SIN16428P
- Approval Date
- 2022-02-14
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
Apply LUCONAC®, External Solution for Nails 5% w/w once daily to the whole affected nail.</p>
<p><strong><Precautions (Related to Dosage and Administration)></strong><br>
Treatment should be continued without interruption until the nail is regenerated and the affected area are finally cured. The required duration of treatment depends essentially on intensity and the localization of the infection and on the growth rate of nails.<br>
LUCONAC®, External Solution for Nails 5% w/w should not be used for a long period of time without a specific reason. Treatment discontinuation and appropriate therapy should be considered if long-term treatment with this product shows no effect.<br>
The safety and efficacy of using LUCONAC®, 5% daily for greater than 48 weeks have not been established.</p>
- Route Of Administration
- TOPICAL
- Indication Info
- <p><strong>INDICATION</strong><br>
<Susceptible strains><br>
Dermatophyte (<em>Trichophyton</em> spp.)<br>
<Indication><br>
As topical treatment in adult patients with mild to moderate tinea unguium with symptoms of distal and lateral subungual onychomycosis</p>
<p><strong><Precautions (Related to Indications)></strong></p>
<ol>
<li>LUCONAC®, External Solution for Nails 5% w/w should be used in patients with a confirmed diagnosis of tinea unguium based on the results from direct microscopy or culture, etc.</li>
<li>The efficacy and safety of LUCONAC®, External Solution for Nails 5% w/w have not been established in severe patients (See "CLINICAL STUDIES" – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ol>
- Contraindications
- <p class="boxed"><strong>Contraindication (LUCONAC®, External Solution for Nails 5% w/w is contraindicated in the following patients)</strong><br>
Patients with a past history of hypersensitivity to any of the ingredients of LUCONAC®, External Solution for Nails 5% w/w.</p>
- Atc Code
- D01AC18
- Atc Item Name
- luliconazole
- Pharma Manufacturer Name
- ZUELLIG PHARMA PTE. LTD.
