Taflotan Special Precautions

Benzalkonium chloride, which is commonly used as a preservative in ophthalmic product, has been reported to have cytotoxicity. Since this product contains benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Contact Lenses: The preservative in this product, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses should be instructed to wait at least 10 minutes after instilling this product before they insert their contact lenses.
Careful administration (This product should be administered with care to the following patients.): Patients with aphakia or pseudophakia [other drugs in this category have been reported to induce macular oedema including cystoid macular oedema, and the associated visual acuity reduced].
Patients with bronchial asthma or a history of bronchial asthma [this product may aggravate or induce asthmatic attack].
Patients with endophthalmitis (iritis, uveitis) [other drugs in this category have been reported to cause elevation of intraocular pressure].
Pregnant, parturient and lactating women [see Use in Pregnancy & Lactation].
Important precautions: Pigmentation in iris and eyelid (increased melanin content), or hypertrichosis around the eyes may occur. These symptoms gradually progress with continued administration, and stops when the treatment is discontinued. The symptoms like eyelid pigmentation and hypertrichosis around the eyes can gradually fade away or diminish after the administration is discontinued, however, there are reports of cases that symptom of iris pigmentation lingers even after the administration is 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 the 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 eyelid pigmentation or hypertrichosis around the eye.
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 or eye pain, continue.
This product should be administered with care because there is no clinical experience in patients with closed angle glaucoma.
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 Pregnancy & Lactation: This product should be used in pregnant women or women who may possibly be pregnant only if the expected therapeutic benefits are judged to outweigh the possible risks associated with the treatment. [The safety of this product for use during pregnancy has not been established. In animal studies, when tafluprost solution was administered intravenously to pregnant rats at doses of 30 μg/kg/day (2000 times the clinical dose*), teratogenicity and post-implantation embryonic mortality rate increased; at 10 μg/kg/day (about 670 times the clinical dose*) adverse effect on fetal development (low body weight and unossification of breast bone of fetuses) was observed. In an intravenous administration in pregnant rabbits at 0.1 μg/kg/day (about 6.7 times the clinical dose*), miscarriage and mortality rate after implantation increased, and luteal body and implantation decreased; at 0.03 μg/kg/day (2 times the clinical dose*) teratogenicity was observed. In an intravenous administration study in pregnant and lactating rats at a dose level of 1 μg/kg/day (about 67 times the clinical dose*), mal-nursing of dams was observed and 4-day survival rate of new born baby decreased. On the other hand, in the study using uteri isolated from rats, uterine contraction was observed at about 3.3 times the plasma concentration of tafluprost (less than 30 pg/mL) or about 420 times the plasma concentration of unbound tafluprost (less than 0.24 pg/mL), calculated based on protein binding ratio, estimated after ocular administration of the clinical dosage.]
*Dosage (0.015 μg/kg/day) when one drop (30 μL) of this product is instilled into both eyes at a time for a 60 kg patient.
Avoid administration to nursing mothers. If administration is judged to be essential, the patients should be instructed to stop breast-feeding during the treatment. [A study in rats has shown excretion of tafluprost in breast milk after ocular instillation.]
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.