- Approval Id
- 3ffa2b64dd11930b
- Drug Name
- ALERCHEK OPHTHALMIC SOLUTION 0.2%
- Product Name
- ALERCHEK OPHTHALMIC SOLUTION 0.2%
- Approval Number
- SIN15526P
- Approval Date
- 2018-08-17
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION, STERILE
- Dosage
- <p>DOSAGE AND ADMINISTRATION<br>
<u>Dosage</u><br>
<em>Adults :</em> One drop in each affected eye once daily.<br>
<em>Elderly :</em> No dosage adjustment in elderly patients is necessary.</p>
<p><em>Pediatric population</em><br>
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.</p>
<p><em>Special populations</em></p>
<ul>
<li>Olopatadine Eye Drops, Solution has not been studied in patients with renal or hepatic disease. However, no dosage adjustment is expected to be necessary in hepatic or renal impairment.</li>
</ul>
<p><u>Method of administration</u></p>
<ul>
<li>For topical ocular use only. Not for injection or oral use.</li>
<li>After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the product.</li>
<li>To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle.</li>
<li>Keep the bottle tightly closed when not in use.</li>
<li>In case of concomitant therapy with other topical ocular medicines, an interval of 5 minutes should be allowed between successive applications. Eye ointments should be administered last.</li>
<li>Patients should be advised not to wear a contact lens if their eye is red.</li>
<li>ALERCHEK Eye Drops, Solution 0.2% should not be used to treat contact lens related irritation.</li>
</ul>
- Route Of Administration
- OPHTHALMIC
- Indication Info
- <p><strong>INDICATIONS</strong><br>
Treatment of ocular itching associated with allergic conjunctivitis.<br>
Results from clinical studies up to 12 weeks duration demonstrate that ALERCHEK 0.2% solution when dosed once a day is effective in the treatment of the ocular signs and symptoms of allergic conjunctivitis and rhinoconjunctivitis, and the nasal symptoms of allergic rhinoconjunctivitis. Conjunctival allergen challenge studies demonstrated that ALERCHEK 0.2% solution is significantly more effective than its vehicle within 3 minutes after antigen challenge and up to 24 hours after dosing.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Hypersensitivity to the active substance or to any of the excipients.</p>
- Atc Code
- S01GX09
- Atc Item Name
- olopatadine
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
