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To be used as directed by physician.
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 active or a history of bronchial asthma. [Asthmatic attack may be exacerbated or induced (see Other Precautions as follows).]
(3) Patients with intraocular inflammation (iritis/uveitis). [Elevated intraocular pressure (IOP) has been reported.]
(4) Patients potentially with latent herpes virus infection. [Herpetic keratitis has been reported.]
(5) Pregnant, parturient, nursing women (see Use in Pregnancy & Lactation).
Important Precautions: (1) When this product is administered, the iris pigmentation may occur (due to increased melanin content). Before using this product, patients who receive treatment should be well informed of the possibility of the iris pigmentation and the change in iris color. It is reported that pigmentation is expected to increase gradually and stops after discontinuation of treatment. However, the resultant pigmentation is likely to be permanent. In addition, iris color change due to the iris pigmentation may occur. In particular, the treatment of one eye may cause iris color difference between the right and left eyes. The pigmentation of the iris has been reported predominantly in patients with brown-based irises. The change in iris color is mild and may not be detected clinically. (See Clinically Significant Adverse Reactions under Adverse Reactions.)
(2) Corneal epithelium disorder (superficial punctate keratitis, filamentary keratitis, corneal erosion) may occur during administration of this product. The patients should be adequately instructed to immediately consult a doctor if the subjective symptoms of eye stinging, itching, and eye pain persist.
(3) This product should be administered with special caution in the patients with angle-closure glaucoma due to an insufficient clinical experience.
(4) Since blurred vision may temporarily occur after administration of the product, patients should be warned not to operate machinery or drive a car until the symptom disappears.
Other Precautions: (1) In overseas reports, retinal artery occlusion, detached retina, and vitreous hemorrhage associated with diabetic retinopathy have been reported as adverse events locally in the eyes, and upper respiratory tract infection, common cold, influenza, myalgia, arthralgia, low back pain, chest pain, angina, rash, and allergic skin reaction have been reported as systemic adverse events.
(2) Infused intravenously in doses (2 μg/kg) of latanoprost in monkeys caused transient increased airway resistance. However, it has been reported that instillation of latanoprost in 11 patients with moderate bronchial asthma at 7 times the recommended clinical dose (recommended dose is 1.5 μg/eye) had no effect on lung function.
Use in the Elderly: Generally elderly patients have declined physiological functions and this product should be administered with caution.
Use in Children: The safety of this product in pediatric patients has not been established. (No clinical data are available for premature infants, newborns, and infants. Very limited clinical data are available for children.)
