- Approval Id
- 91a3ce6c019789b4
- Drug Name
- MYDRIACYL STERILE OPHTHALMIC SOLUTION 1%
- Product Name
- MYDRIACYL STERILE OPHTHALMIC SOLUTION 1%
- Approval Number
- SIN04715P
- Approval Date
- 1990-06-13
- Registrant
- ALCON PTE LTD
- Licence Holder
- ALCON PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
<strong>Posology</strong></p>
<ul>
<li>For examination of the fundus: 1 or 2 drops of the 0.5 % solution in the eye(s), 15 or 20 minutes prior to examination.</li>
<li>For refraction: 1 or 2 drops of the 1.0 % solution in the eye(s) repeated in 5 minutes. If the patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong the mydriatic effect.</li>
</ul>
<p><u>Use in patients with hepatic or renal impairment</u><br>
The safety and efficacy of MYDRIACYL Ophthalmic Solution in patients with hepatic and renal impairment have not been established.</p>
<p><strong>Method of administration</strong><br>
For topical ophthalmic use only.<br>
After cap is removed, if tamper evident snap collar is loose, remove before using product.<br>
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.<br>
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. Keep the bottle tightly closed when not in use.<br>
If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart. Eye ointments should be administered last.</p>
- Route Of Administration
- OPHTHALMIC
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
MYDRIACYL Ophthalmic Solution contains tropicamide, which is pharmacologically related to the parasympatholytic (anticholinergic) group. It is a mydriatic and cycloplegic. MYDRIACYL Ophthalmic Solution is indicated for mydriasis and cycloplegia for diagnostic purposes.<br>
The 0.5 % solution is recommended where mydriasis only is desired. For cycloplegic effect in refractions, the 1.0 % solution is necessary.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Hypersensitivity to the active substance 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>Patients with known or suspected angle-closure glaucoma.</li>
</ul>
- Atc Code
- S01FA06
- Atc Item Name
- tropicamide
- Pharma Manufacturer Name
- ALCON PTE LTD
