Avetaprost Special Precautions

Warnings: The product has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes, and growth of eyelashes. Pigmentation of the iris is likely to be permanent.
The colour change is due to increased melanin content in the stromal melanocytes of the iris and not to an increase in number of melanocytes. The long-term effect on the melanocytes and the consequences of potential injury to the melanocytes and/or deposition of pigment granules to other areas of the eye are currently unknown. The iris colour change is slightly in the majority of cases and often not observed clinically. Patients who receive treatment should be informed of the possibility of increased pigmentation.
Eyelid skin darkening, which may be reversible, has been reported in association with the use of this medication.
The product may gradually change eyelashes, and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment.
Patients should be informed of the possibility of a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth.
Do not use the product if the patient is allergic (hypersensitive) to latanoprost, benzalkonium chloride or any of the other ingredients of the product.
Take special care with the product: There is no experience of the product in inflammatory and neovascular glaucoma, inflammatory ocular conditions, or congenital glaucoma. Therefore, it is recommended that the product should be used with caution in these conditions until more experience is obtained.
In patients with known predisposing risk factors for iritis/uveitis, the product can be used with caution.
This medication should be used with caution in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
This medication should be used with caution in patients with renal or hepatic impairment.
Pediatric Population: Efficacy and safety data in the age group <1 year are very limited. No data are available for preterm infants (less than 36 weeks gestational age).
Precautions during administration: Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye. Patients developed an intercurrent ocular condition (e.g., trauma, or infection) or had ocular surgery should take special care with this drug product.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart
Latanoprost should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues.