- Approval Id
- 9ba29eab5df50f96
- Drug Name
- DEXTENZA Ophthalmic Insert 0.4 mg
- Product Name
- DEXTENZA Ophthalmic Insert 0.4 mg
- Approval Number
- SIN17195P
- Approval Date
- 2025-03-05
- Registrant
- EVERARC PHARMACEUTICALS (SG) PTE. LTD.
- Licence Holder
- HASTEN BIOPHARMACEUTICALS (SG) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INSERT, EXTENDED RELEASE
- Dosage
- <p><strong>3. DOSAGE AND ADMINISTRATION</strong><br>
<strong>3.1. General Dosing Information</strong><br>
DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus. A single DEXTENZA insert releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion.</p>
<p>DEXTENZA is resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insert if necessary. DEXTENZA is intended for single-use only.</p>
<p><strong>3.2. Administration</strong><br>
Do not use if pouch has been damaged or opened. Do not re-sterilize.</p>
<ol>
<li>Carefully remove foam carrier and transfer to a clean and dry area.</li>
<li>If necessary, dilate the punctum with an ophthalmic dilator. Care should be taken not to perforate the canaliculus during dilation or insertion of DEXTENZA. If perforation occurs, do not insert DEXTENZA.</li>
<li>After drying the punctal area, using blunt (non-toothed) forceps, grasp DEXTENZA and insert into the lower lacrimal canaliculus by pulling the lid temporally and inserting nasally.</li>
<li>Ensure DEXTENZA is placed just below the punctal opening. Excessive squeezing of DEXTENZA may cause deformation.</li>
<li>To aid in the hydration of DEXTENZA, 1 to 2 drops of balanced salt solution can be instilled into the punctum. DEXTENZA hydrates quickly upon contact with moisture. If DEXTENZA begins to hydrate before fully inserted, discard the product and use a new DEXTENZA.</li>
<li>DEXTENZA can be visualized when illuminated by a blue light source (e.g., slit lamp or hand held blue light) with yellow filter.</li>
</ol>
- Route Of Administration
- OPHTHALMIC
- Indication Info
- <p><strong>2. INDICATIONS AND USAGE</strong><br>
<strong>2.1 Ocular Inflammation and Pain Following Ophthalmic Surgery</strong><br>
DEXTENZA (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery (Refer to Section 12.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>2.2 Itching Associated with Allergic Conjunctivitis</strong><br>
DEXTENZA (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular itching associated with allergic conjunctivitis (Refer to Section 12.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>4. CONTRAINDICATIONS</strong><br>
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis.</p>
- Atc Code
- S01BA01
- Pharma Manufacturer Name
- LABCORP DEVELOPMENT (ASIA) PTE. LTD.
- Company Detail Path
- /organization/labcorp-development-asia-pte-ltd
