- Approval Id
- de5cdc87fd106b42
- Drug Name
- ADLARITY TRANSDERMAL SYSTEM 5 mg/24 hours
- Product Name
- ADLARITY TRANSDERMAL SYSTEM 5 mg/24 hours
- Approval Number
- SIN17381P
- Approval Date
- 2025-11-03
- Registrant
- LOTUS INTERNATIONAL PTE. LTD.
- Licence Holder
- LOTUS INTERNATIONAL PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- PATCH, EXTENDED RELEASE
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Recommended Dosage</strong></p>
<p>The recommended starting dosage of ADLARITY is 5 mg/day. After 4 to 6 weeks, the dosage may be increased to the maximum recommended dosage of 10 mg/day. Administer ADLARITY as one transdermal system applied to the skin once weekly <em>[see Dosage and Administration (2.3)]</em>.</p>
<p>Doses of the transdermal system higher than the 10 mg/day equivalent have not been evaluated.</p>
<p><strong>2.2 Switching to ADLARITY from Donepezil Hydrochloride Tablets or Donepezil Hydrochloride ODT</strong></p>
<p>Patients treated with donepezil hydrochloride 5 mg or 10 mg tablets may be switched to ADLARITY:</p>
<ul>
<li><p>A patient who is being treated with a total daily dose of 5 mg of oral donepezil hydrochloride can be switched to the once weekly 5 mg/day ADLARITY transdermal system. If a patient has been on 5 mg oral donepezil hydrochloride for at least 4–6 weeks, the patient may be switched immediately to the once weekly 10 mg/day transdermal system.</p></li>
<li><p>A patient who is being treated with a total daily dose of 10 mg of oral donepezil hydrochloride can be switched to the once weekly 10 mg/day ADLARITY transdermal system.</p></li>
</ul>
<p>Instruct patients or caregivers to apply the first transdermal system with the last administered oral dose.</p>
<p><strong>2.3 Administration Information</strong></p>
<p>Each ADLARITY transdermal system delivers either 5 mg or 10 mg of donepezil daily for 7 days (one-week cycle). At the end of 7 days, the used transdermal system is removed, and a new transdermal system is applied. Only one transdermal system should be applied at a time.</p>
<p>See the Instructions for Use for step-by-step instructions.</p>
<p><u>Preparation</u></p>
<ul>
<li>Remove one ADLARITY transdermal system from the refrigerator and allow the pouch to reach room temperature before opening.
<ul class="circle">
<li>Do not use external heat sources to warm ADLARITY.</li>
<li>Do not apply a cold transdermal system.</li>
<li>Use within 24 hours of removing from the refrigerator.</li>
</ul></li>
<li><p>Ensure the ADLARITY pouch seal has not been broken. Do not use ADLARITY if the transdermal system is damaged, cut, or altered in any way.</p></li>
<li>Select application site:
<ul>
<li>The recommended application site is the back (avoiding the spine). If needed, the upper buttocks or the upper outer thigh may be used <em>[see Clinical Studies (14.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. Use a location that will not be rubbed by tight clothing.</li>
<li>Do not use the same location of an application site for at least 2 weeks (14 days) after removal of a transdermal system from that location.</li>
<li>Do not apply to an area on skin where medication, cream, lotion, or powder has recently been applied.</li>
<li>Do not apply to skin that is red, irritated, or cut.</li>
<li>Do not shave the site.</li>
</ul></li>
</ul>
<p><u>Application</u></p>
<ul>
<li>Apply ADLARITY to skin immediately after removing from the pouch.</li>
<li>Apply to clean, dry, intact healthy skin with no to minimal hair <em>(see Preparation)</em>.</li>
<li>Press down firmly for 30 seconds to ensure good contact with skin at the edges of the transdermal system.</li>
<li>ADLARITY use does not need to be interrupted due to bathing or hot weather. Avoid long exposure to external heat sources (e.g., excessive sunlight, saunas, solariums or heating pads).</li>
</ul>
<p><strong>2.4 Missed Dose</strong></p>
<p>If an ADLARITY transdermal system falls off, or if a dose is missed, apply a new transdermal system immediately and then replace this transdermal system 7 days later to start a new one- week cycle <em>[see Dosage and Administration (2.3)]</em>.
- Route Of Administration
- TRANSDERMAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>ADLARITY is indicated for the symptomatic treatment of mild, moderate, and severe dementia of the Alzheimer’s type.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>ADLARITY is contraindicated in:</p>
<ul>
<li><p>Patients with known hypersensitivity to donepezil or to piperidine derivatives</p></li>
<li><p>Patients with a history of allergic contact dermatitis with use of ADLARITY <em>[see Warnings and Precautions (5.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em></p></li>
<li><p>Patients who are pregnant</p></li>
</ul>
