- Approval Id
- c07c55d3f78e84e5
- Drug Name
- GLAALPHA COMBINATION OPHTHALMIC SOLUTION
- Product Name
- GLAALPHA COMBINATION OPHTHALMIC SOLUTION
- Approval Number
- SIN17265P
- Approval Date
- 2025-06-25
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SOLUTION, STERILE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Posology</strong><br>
<u>Use in adults, including the elderly</u><br>
Instill one drop at a time, twice a day.</p>
<p><u>Use in pediatric population</u><br>
No clinical studies have been conducted to evaluate the efficacy and safety in pediatric patients (see Section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Method of Administration</strong></p>
<ol class="decimal-enclosed">
<li>Route of administration: Instillation only.</li>
<li>When dispending the drug: Instruct patients on the following:
<ol class="decimalparen">
<li>In the instillation, the patient should open the affected eye, instill the drug into the conjunctival sac, close the eyelid for 1 to 5 minutes while compressing the lacrimal part, and open the eye.</li>
<li>Be careful during the instillation to avoid direct contact of the tip of the container with the eye in order to prevent contamination of the drug.</li>
<li>Instill with an interval of at least 5 minutes when using the drug in combination with other ophthalmic solutions.</li>
</ol>
</li>
</ol>
- Route Of Administration
- OPHTHALMIC
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>GLAALPHA is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>GLAALPHA is contraindicated in patients with a history of hypersensitivity to any of the components of GLAALPHA (see Section 2 and 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
GLAALPHA is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.</p>
