- Approval Id
- 794758e174ba6c92
- Drug Name
- ARISTO-LATA LATANOPROST EYE DROPS 0.005% W/V
- Product Name
- ARISTO-LATA LATANOPROST EYE DROPS 0.005% W/V
- Approval Number
- SIN17024P
- Approval Date
- 2024-06-11
- Registrant
- APEX PHARMA MARKETING PTE. LTD.
- Licence Holder
- APEX PHARMA MARKETING PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>4.2 Dosage and route of administration</strong></p>
<p><u>Dosage</u></p>
<p><em>Adults (including elderly people):</em></p>
<p>The recommended dose is one eye drop in the affected eye or eyes, once daily. The best effect is achieved when Latanoprost is administered in the evening.</p>
<p>Aristo-LATA should not be administered more than once daily as more frequent administration reduces the IOP reduction effect.</p>
<p>If a dose is missed, treatment is continued with the next dose as usual.</p>
<p>Paediatric population:<br>
Aristo-LATA eye drops can be used in paediatric patients, with the same dosage as in adults. No data are available for premature infants (with a gestational age of less than 36 weeks). Data from the age group < 1 year (4 patients) are limited (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
<u>Methods of administration</u><br>
As with all eye drops, to reduce potential systemic absorption, it is recommended that the lacrimal sac be compressed at the medial canthus (lacrimal punctal occlusion) for one minute. This should be performed immediately after instillation of each drop.</p>
<p>Contact lenses should be removed before instillation of eye drops and can be put back in after 15 minutes.</p>
<p>If more than one topical ophthalmic medicinal product is administered, the medicinal products should be administered at least five minutes apart.</p>
- Route Of Administration
- OPHTHALMIC
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Reduction of increased intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension in adults (including the elderly). It may also be used for the reduction of elevated intraocular pressure as an adjunct medical therapy in patients with primary chronic angle closure glaucoma.</p>
<p>Reduction of increased IOP in paediatric patients with increased IOP and paediatric glaucoma.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to Latanoprost 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>.</p>
- Atc Code
- S01EE01
- Pharma Manufacturer Name
- APEX PHARMA MARKETING PTE. LTD.
