Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SOLUTION
**DOSAGE AND ADMINISTRATION** Apply LUCONAC®, External Solution for Nails 5% w/w once daily to the whole affected nail. **<Precautions (Related to Dosage and Administration)>** 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. 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. The safety and efficacy of using LUCONAC®, 5% daily for greater than 48 weeks have not been established.
TOPICAL
Medical Information
**INDICATION** <Susceptible strains> Dermatophyte ( _Trichophyton_ spp.) <Indication> As topical treatment in adult patients with mild to moderate tinea unguium with symptoms of distal and lateral subungual onychomycosis **<Precautions (Related to Indications)>** 1. 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. 2. The efficacy and safety of LUCONAC®, External Solution for Nails 5% w/w have not been established in severe patients (See "CLINICAL STUDIES" – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**Contraindication (LUCONAC®, External Solution for Nails 5% w/w is contraindicated in the following patients)** Patients with a past history of hypersensitivity to any of the ingredients of LUCONAC®, External Solution for Nails 5% w/w.
D01AC18
luliconazole
Manufacturer Information
ZUELLIG PHARMA PTE. LTD.
Sato Pharmaceutical Co., Ltd. Kazusa Akademia Factory
Active Ingredients
Documents
Package Inserts
Luconac PI_Approved.pdf
Approved: July 29, 2022