- Approval Id
- 74f8ffcc9d2d6489
- Drug Name
- BRITIL EYE DROPS, SUSPENSION 1% w/v
- Product Name
- BRITIL EYE DROPS, SUSPENSION 1% w/v
- Approval Number
- SIN17215P
- Approval Date
- 2025-04-08
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SUSPENSION, STERILE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Posology/administration frequency and period:</strong><br>
<p>When used as monotherapy or adjunctive therapy, BRITIL is administrated as one drop twice a day to the conjunctival sac of the affected eye(s). Some patients may have a better response with one drop three times a day.</p>
<p>When substituting another ophthalmic antiglaucoma agent with BRITIL, discontinue the other agent and start the following day with BRITIL eye drops.</p>
<p>If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.</p>
<p><strong>Method of administration</strong></p>
<p>For ocular use.</p>
<p>Nasolacrimal occlusion or gently closing the eyelid for 2 minutes after instillation is recommended. This may result in a decrease in systemic side effects and an increase in local activity.</p>
<p>Shake well before use. To prevent contamination of the dropper tip and suspension, care must be taken not to touch dropper tip of the bottle to eyelids, surrounding areas or other surfaces. Keep the bottle tightly closed when not in use.</p>
<p>Patients must be instructed to remove soft contact lenses prior to application of BRITIL, and to wait 15 minutes after instillation of the dose before reinsertion.</p>
<p><strong>Additional information to special populations:</strong></p>
<p><strong>Renal/Liver Impairment:</strong></p>
<p>Brinzolamide has not been studied in patients with liver impairment and is therefore not recommended in such patients.</p>
<p>Brinzolamide has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m<sup>2</sup>) or in patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted predominantly by the kidney, BRITIL is therefore contra-indicated in such patients (see also section 4.3). In patients with moderate renal impairment (creatinine clearance 30–60 mL/min/1.73 m<sup>2</sup>) there is no need for dose adjustments with topical administration of brinzolamide 1%.</p>
<p><strong>Paediatric population</strong></p>
<p>The safety and efficacy of Brinzolamide has not been established in patients under 18 years and usage of it in these patients is not recommended.</p>
<p><strong>Geriatric Population:</strong></p>
<p>Dosage alteration is not required in elderly patients.</p>
- Route Of Administration
- OPHTHALMIC
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong></p>
<p>BRITIL is indicated to decrease elevated intraocular pressure in adult patients with:</p>
<ul>
<li>ocular hypertension,</li>
<li>open-angle glaucoma,</li>
</ul>
<p>as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers. (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Hypersensitivity to Brinzolamide or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Known hypersensitivity to sulphonamides (see also section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Severe renal impairment.</li>
<li>Hyperchloraemic acidosis.</li>
</ul>
- Atc Code
- S01EC04
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
