Taflotan-S Special Precautions

Do not use more than once daily because more frequent administration may lessen the IOP lowering effect.
Careful administration (This product should be administered with care to the following patients): 1) Patients with aphakia or pseudophakia [this product may induce macular oedema including cystoid macular oedema, and the associated visual acuity reduced.]
2) Patients with bronchial asthma or a history of bronchial asthma [this product may aggravate or induce asthmatic attack.]
3) Patients with endophthalmitis (iritis, uveitis) [other drugs in this category have been reported to cause elevation of intraocular pressure.]
4) Pregnant, parturient and lactating women [see Use in Pregnancy & Lactation].
Important precautions: 1) Pigmentation in iris and eyelid (increased melanin content), or hypertrichosis around the eyes may occur. These symptoms gradually progress with continued administration, and stop when the treatment is discontinued. The symptoms like blepharal pigmentation and hypertrichosis around the eyes can gradually disappear or diminish after the administration is discontinued, however, there are reports of the cases that the symptom of iris pigmentation persists even after the administration was discontinued. In such cases, iris color change can be detected clearly in patients with mixed-colored irises and even in patients with single-color dark brown irises (seen among most Japanese) as well. The difference in iris color between right and left eyes could be noted particularly in the case of unilateral administration. As long-term observation data about these symptoms are not yet available, doctors are required to closely observe patients through periodic checkups. Patients should be well informed of the possibility of these symptoms and instructed to wipe off any excess solution from the skin around the eye or to wash the face in order to prevent blepharal pigmentation or hypertrichosis around eyes.
2) Corneal epithelium disorder (superficial punctate keratitis, filamentary keratitis or corneal erosion) may occur during the treatment. Instruct patients to consult a doctor immediately if subjective symptoms including smarting pain, itching and eye pain continue.
3) This product should be administered with care because there is no clinical experience in patients with closed angle glaucoma.
4) Temporary blurred vision may develop after administration of this product. Patients should be instructed to refrain from activities like driving or operating machines until the symptom disappears.
Use in children: The safety of this product to low birth weight infants, neonates, infants or children has not been established. (No clinical experience.)
Use in elderly: Because physiological function is generally reduced in the elderly, caution should be exercised.