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Careful administration (This product should be administered with care to the following patients.): Patients with right ventricular failure caused by pulmonary hypertension [Symptoms may be aggravated due to negative chronotropic/inotropic effects caused by β-receptor blockage.].
Patients with congestive heart failure [Symptoms may be aggravated due to negative chronotropic/inotropic effects caused by β-receptor blockage.].
Patients with diabetic ketoacidosis or metabolic acidosis [This product may enhance the depression of myocardial contraction caused by acidosis].
Patients with poor-controlled diabetes [Pay attention to the blood glucose level because this product may mask hypoglycemia.].
Patients with aphakia or pseudophakia [Other drugs in this category have been reported to induce macular oedema including cystoid macular oedema, and associated visual acuity reduction.].
Patients with intraocular inflammation (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: This product is a combination ophthalmic solution containing 15 µg/mL of tafluprost and 6.83 mg/mL of timolol maleate equivalent to timolol 5 mg/mL. Use this product appropriately because adverse drug reactions may be induced by both of the previously mentioned active ingredients.
This product may be absorbed systemically, and cause adverse drug reactions similar to those caused by systemic administration of a β-blocker.
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 treatment is discontinued. Symptoms like blepharal pigmentation and hypertrichosis around the eyes can gradually disappear or diminish after administration is discontinued, however, there are reports that iris pigmentation persisted even after administration was discontinued. In such cases, iris color change can be detected clearly in patients with mixed-color 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 their faces in order to prevent blepharal pigmentation or hypertrichosis around eyes.
Corneal epithelium disorder (superficial punctate keratitis, filamentary keratitis or corneal erosion) may occur during treatment. Instruct patients to consult a doctor immediately if symptoms including eye stinging, itching, and eye pain continue.
This product should be administered carefully, because there is no clinical experience in patients with closed angle glaucoma.
Pay close attention when medication is switched from a miotic to this product. This is because the switch from a miotic to timolol maleate may require refraction adjustment due to loss of miotic action.
Precautions concerning use: Priority should be given to monotherapy in principle.
Do not use more than once daily because more frequent administration may lessen the intraocular pressure (IOP) lowering effect.
Route of administration: Ophthalmic use only.
At the time of administration: The following instructions should be given to patients: Be careful not to touch the tip of the bottle to the eye directly in order to avoid contamination of the drug.
In principle, lie supine, the eyelids apart and instill the product into the conjunctival sac, then close the eye and press the lacrimal sac for 1-5 minutes.
Wipe off or wash the face immediately when any excess solution touches the skin around the eye.
When more than one ophthalmic drug is used, at least 5 minutes of intervals should be taken.
Contact lenses should be removed prior to administration because benzalkonium chloride may care discoloration of the lenses. Wait at least 15 minutes before wearing the contact lenses again.
Effects on ability to drive and use machine: Temporary blurred vision may develop after administration of this product. Instruct patients to refrain from activities including driving or operating machinery until the symptom disappears.
Use in Children: The safety of this product in low-birth-weight infants, neonates, infants or children has not been established. (No clinical experience.).
Use in the Elderly: Because physiological function is generally reduced in the elderly, caution should be exercised.
