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Careful Administration: This product should be administered with special caution in the following patients: (1) Aphakic patients, pseudophakic patients with a torn posterior lens capsule. Macular edema, including cystoid macular edema and the decreased visual acuity associated with macular edema, have been reported.
(2) Patients with intraocular inflammation (iritis/uveitis). Elevated intraocular pressure (IOP) has been reported.
(3) Pregnant, parturient, nursing women. See Use in Pregnancy & Lactation.
Important Precautions: When this product is administered, the color change of the iris or eyelids may occur due to pigmentation (increased melanin); hypertrichosis around eyes may also occur. These changes progress gradually while continuously using this product and stop upon discontinuation of use. The change in eyelid color and periocular hypertrichosis may gradually disappear or subside after discontinuation. On the other hand, it has been reported that the iris color change does not disappear even discontinuation of use. In patients with a multi-colored iris, the iris color change is clearly noticeable; in patients with a mono-colored dark-brown iris (many of the Japanese people), such change has been observed as well. In particular, the treatment of one eye may cause iris color difference between the right and left eyes. With regard to these symptoms, since there is no sufficient long-term data, the patients should be regularly examined by a physician and observed closely. Patients should be fully informed of these symptoms before use. In addition, to prevent or reduce the discoloration of eyelids and periocular hypertrichosis, patients should be instructed to remove the product liquid in case of contact with the eyelids or skin by wiping off or washing the face.
Corneal epithelium disorder (superficial punctate keratitis, filamentary keratitis, corneal erosion) may occur during administration of this product. The patients should be adequately instructed to seek medical attention immediately if the subjective symptoms of eye stinging, itching, and eye pain persist.
This product should be administered with special caution in the patients with angle-closure glaucoma due to an insufficient clinical experience.
Since blurred vision may temporarily occur after administration of the product, patients should be advised to refrain from operating machinery or driving a car until the symptoms recover.
Other Precautions: High frequency of occurring deepening of the eyelid sulcus has been reported in many studies.
Use in the Elderly: In general, elderly patients often have decreased physiological functions; therefore, this product should be administered with caution.
Use in Children: The safety of this product has not been established in low birth-weight infants, neonates, infants, and children (no sufficient clinical data).
