TAPCOM Tafluprost / Timolol Maleate 15mcg / 5mg per mL Ophthalmic Solution 2.5mL 1's

Reduction of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues and require a combination therapy.

 

Instill 1 drop in the affected eye(s) once daily.

Patients with bronchial asthma or a history of bronchial asthma, bronchospasm, or severe chronic obstructive pulmonary disease [Asthmatic attack may be aggravated or induced due to bronchial smooth muscle contraction caused by β-receptor blockage.]
Patients with poor-controlled cardiac failure, sinus bradycardia, second- or third-degree atrioventricular block, or cardiogenic shock [These symptoms may be aggravated due to negative chronotropic/inotropic effects caused by β-receptor blockage.]
Patients with a history of hypersensitivity to any of the ingredients in this product.

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. [This product has 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 mcg/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 above 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 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 the 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 cause discoloration of the lenses. Wait at least 15 minutes before wearing the contact lenses again.
Use in Pregnancy & Lactation: This product should be used for 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 a dose of 30 mcg/kg/day (2000 times the clinical dose*), teratogenicity and post-implantation embryonic mortality rate increased; at 10 mcg/kg/day (about 670 times the clinical dose*) adverse effects on fetal development (low body weight and unossification of breast bone in fetuses) was observed. In intravenous administration in pregnant rabbits at 0.1 mcg/kg/day (about 6.7 times the clinical dose*), the miscarriage and mortality rate after implantation increased, and luteal body and implantation decreased; at 0.03 mcg/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 mcg/kg/day (about 67 times the clinical dose*), mal-nursing of dams was observed and the 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 the protein binding ratio, estimated after ocular administration of the clinical dosage.]
*Dosage (0.015 mcg/kg/day) when one drop (30 mcL) of tafluprost ophthalmic solution 0.0015% 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 in rats. Timolol maleate may be excreted in human breast milk.]
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 Elderly: Because physiological function is generally reduced in the elderly, caution should be exercised.

 

Use In Pregnancy & Lactation

Adverse drug reactions (including abnormal change in laboratory test values) were reported in 94 of 379 patients (24.8%) in clinical studies in Japan. The major adverse drug reactions were abnormality in eyelashes in 35 patients (9.2%), conjunctival injection in 32 patients (8.4%), corneal epithelium disorder including punctate keratitis in 21 patients (5.5%), blepharal pigmentation in 9 patients (2.4%), eye irritation in 8 patients (2.1%), etc.
Clinically significant adverse reaction: Iris pigmentation (incidence unknown)*: Iris pigmentation may occur. Patients should be examined periodically, and administration should be discontinued depending on clinical status when iris pigmentation is observed.
Ocular pemphigoid (incidence unknown)*: Ocular pemphigoid may occur. Discontinue administration and treat the patient appropriately when symptoms including conjunctival injection, corneal epithelium disorder, keratoconjunctivitis sicca, conjunctival atrophy, ciliary entropion or symblepharon are observed.
Bronchospasm, dyspnea, respiratory failure (incidence unknown)*: Bronchospasm, dyspnea or respiratory failure may occur. Discontinue administration and treat the patient appropriately if such symptoms are observed.
Heart block, congestive heart failure, cerebral ischemia, cardiac arrest, cerebrovascular disorder (incidence unknown)*: Heart block, congestive heart failure, cerebral ischemia, cardiac arrest or cerebrovascular disorder may occur. Discontinue administration and treat the patient appropriately if such symptoms are observed.
Systemic lupus erythematosus (incidence unknown)*: Systemic lupus erythematosus may occur. Discontinue administration and treat the patient appropriately if such symptom is observed.
*Adverse drug reactions which have been reported in use of tafluprost or timolol maleate.
Other adverse drug reactions: If an adverse drug reaction is observed, appropriate measures including discontinuing administration should be taken. (See Table 4.)

Storage

Action

Antiglaucoma Preparations