Taflotan

Taflotan

tafluprost

Manufacturer:

Santen

Distributor:

Metro Drug
Full Prescribing Info
Contents
Tafluprost.
Description
Tafluprost (Taflotan) ophthalmic solution is a clear, colorless, sterile aqueous ophthalmic solution containing 15 mcg of tafluprost as an active ingredient in each mL. It also contains polysorbate 80, concentrated glycerin, disodium edetate hydrate, sodium dihydrogen phosphate dihydrate and benzalkonium chloride as additives.
Action
Pharmacology: Pharmacodynamics: Clinical studies: In a randomized blind comparative study in 109 patients with primary open angle glaucoma or ocular hypertension using latanoprost ophthalmic solution as a comparator, the decrease in intraocular pressure (IOP) for this product was 6.6 mmHg (95% confidence interval: 5.8-7.3 mmHg), which demonstrated non inferiority to the comparator. (See Table 1.)

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In a randomized blind comparative study in 94 patients with normal tension glaucoma using placebo ophthalmic solution as a comparator, the decrease in IOP for this product was 4.0 mmHg (95% confidence interval: 3.5-4.5 mmHg), which showed significant IOP lowering effect compared with placebo. (See Table 2.)

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In a long-term administration study in 351 patients with open angle glaucoma including normal tension glaucoma, or patients with ocular hypertension, the decrease in IOP for this product remained between 4.9 and 5.7 mmHg for 52 weeks, which demonstrated stable IOP lowering effect in long-term administration. IOP decrease was 6.0-6.9 mmHg in cohort 1* and 3.4-4.0 mmHg in cohort 2 over 52 weeks. (See figure.)

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Indications/Uses
Glaucoma and ocular hypertension.
Dosage/Direction for Use
Instill 1 drop in the affected eye(s) once daily.
Contraindications
This product is contraindicated in the patients with a history of hypersensitivity to any of the ingredients of this product.
Special Precautions
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 during Pregnancy, Delivery or Lactation as follows).
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 the cases that the symptom of iris pigmentation lingers 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 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 eyelid pigmentation or hypertrichosis around eyes.
Corneal epithelium disorder (superficial punctate keratitis, filamentary keratitis or corneal erosion) may occur during the treatment. Instruct the patients to consult a doctor immediately if subjective symptoms including smarting pain, itching and 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 during Pregnancy, Delivery or 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 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 effect on fetal development (low body weight and unossification of breast bone in fetuses) was observed. In an intravenous administration in pregnant rabbits at 0.1 mcg/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 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 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 mcg/kg/day) when one drop (30 mcL) 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 the Elderly: Because physiological function is generally reduced in the elderly, caution should be exercised.
Use In Pregnancy & Lactation
Use during Pregnancy, Delivery or 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 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 effect on fetal development (low body weight and unossification of breast bone in fetuses) was observed. In an intravenous administration in pregnant rabbits at 0.1 mcg/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 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 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 mcg/kg/day) when one drop (30 mcL) 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.]
Adverse Reactions
Adverse drug reactions (including abnormal change in laboratory test values) were reported in 326 of 483 patients (67.5%). The major adverse reactions were conjunctival injection in 151 patients (31.3%), abnormality in eyelashes in 93 patients (19.3%), itching in 85 patients (17.6%), eye irritation in 65 patients (13.5%), and iris pigmentation in 39 patients (8.1%) etc. (Before approval.)
Clinically significant adverse reaction: Iris pigmentation (8.1%): Since iris pigmentation may occur, patients should be examined periodically, and administration should be discontinued depending on the clinical status when iris pigmentation is observed.
Other: If the following adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See Table 3.)

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Caution For Usage
Precautions concerning Use: Do not use more than once daily because more frequent administration may lessen the IOP lowering effect.
At the time of administration, followings should be instructed 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.
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 as benzalkonium chloride contained may cause discoloration of the lenses. Wait for at least 15 minutes before wearing the contact lenses again.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Antiglaucoma Preparations
ATC Classification
S01EE05 - tafluprost ; Belongs to the class of prostaglandin analogues. Used in the treatment of glaucoma.
Presentation/Packing
Ophth soln 15 mcg/mL x 2.5 mL.
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