- Approval Id
- 4eb2ae8e154c2d6d
- Drug Name
- LAMISIL TABLET 250 mg
- Product Name
- LAMISIL TABLET 250 mg
- Approval Number
- SIN06932P
- Approval Date
- 1992-04-13
- Registrant
- NOVARTIS (SINGAPORE) PTE LTD
- Licence Holder
- NOVARTIS (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE REGIMEN AND ADMINISTRATION</strong></p>
<p><strong>Dosage Regimen</strong></p>
<p>The duration of treatment varies according to the indication and the severity of the infection.</p>
<p><strong>Adults</strong></p>
<p>250 mg once daily.</p>
<p><strong>Skin infections</strong></p>
<p>Recommended duration of treatment:</p>
<ul>
<li>Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks.</li>
<li>Tinea corporis, T. cruris: 2 to 4 weeks.</li>
<li>Cutaneous candidiasis: 2 to 4 weeks.</li>
</ul>
<p>Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.</p>
<p><strong>Hair and scalp infections</strong></p>
<p>Recommended duration of treatment:</p>
<ul><li>Tinea capitis: 4 weeks.</li></ul>
<p>Tinea capitis occurs primarily in children.</p>
<p><strong>Onychomycosis</strong></p>
<p>For most patients the duration of successful treatment is 6 to 12 weeks.</p>
<p><strong>Fingernail onychomycosis</strong></p>
<p>Six weeks of therapy is sufficient for fingernail infections in most cases.</p>
<p><strong>Toenail onychomycosis</strong></p>
<p>Twelve weeks of therapy is sufficient for toenail infections in most cases.</p>
<p>Some patients with poor nail outgrowth may require longer treatment. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.</p>
<p><strong>Special populations</strong></p>
<p><strong>Hepatic impairment</strong></p>
<p>Lamisil tablets are contraindicated for patients with chronic or active hepatic disease (see sections CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Renal impairment</strong></p>
<p>The use of Lamisil tablets has not been adequately studied in patients with renal impairment and is therefore not recommended in this population (see section WARNINGS AND PRECAUTIONS and section PHARMACOKINETICS (PK) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Geriatric Patients</strong></p>
<p>There is no evidence to suggest that elderly patients (aged 65 years and above) require different dosages or experience different side effects than younger patients. When prescribing Lamisil tablets for patients in this age group, the possibility of pre-existing impairment of liver or kidney function should be considered (see section WARNINGS AND PRECAUTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Pediatric Patients</strong></p>
<p>No data are available in children under two years of age (usually <12 kg).</p>
<table class="borderless-100">
<tbody>
<tr>
<td>Children weighing</td>
<td><20 kg</td>
<td>62.5 mg</td>
<td>(half a 125 mg tablet) once daily</td>
</tr>
<tr>
<td>Children weighing</td>
<td>20 to 40 kg</td>
<td>125 mg</td>
<td>(one 125 mg tablet) once daily</td>
</tr>
<tr>
<td>Children weighing</td>
<td>>40 kg</td>
<td>250 mg</td>
<td>(two 125 mg tablets) once daily</td>
</tr>
</tbody>
</table>
<p><strong>Method of administration</strong></p>
<p>The scored tablets are taken orally with water. They should preferably be taken at the same time each day and can be taken on an empty stomach or after a meal.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong></p>
<p>Treatment of:</p>
<ul>
<li><p>Onychomycosis (fungal infection of the nail) caused by dermatophyte fungi.</p></li>
<li><p>Tinea capitis.</p></li>
<li><p>Fungal infections of the skin (Tinea corporis, Tinea cruris, Tinea pedis) and yeast infections of the skin caused by the genus Candida (e.g. Candida albicans) where oral therapy is generally considered appropriate owing to the site, severity or extent of the infection.</p></li>
</ul>
<p>Note: In contrast to topical Lamisil, oral Lamisil is not effective in Pityriasis versicolor (also known as <em>Tinea versicolor</em>).</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<ul>
<li><p>Known hypersensitivity to terbinafine or to any of the excipients of Lamisil tablets.</p></li>
<li><p>Chronic or active hepatic diseases</p></li>
</ul>
- Atc Code
- D01BA02
- Atc Item Name
- terbinafine
- Pharma Manufacturer Name
- NOVARTIS (SINGAPORE) PTE LTD
