Taflotan Santen eye drops reduce high eye pressure (2.5ml)

Dosage form Box X 2.5ml
Specifications Tafluprost

Ingredient

Composition information	Content
Tafluprost	0.0015%

Uses

Indications

Taflotan® drugs are indicated in cases of reducing high -labeled pressure in patients with open angle Glaucoma or glaucoma.

Pharmacokological

Mechanism of action: Tafluprost acid, a prostaglandin coin is a selective FP of Prustenoidal Translation, which is said to reduce intraocular pressure by increasing fluid flow flow. The exact mechanism of action is not known at this time.

pharmacokinetic pharmacokinetics

plasma concentrations when using Tafluprost solution concentration of 0.0025% or 0.005% 1 drop once a day for 7 days on both eyes for 7 healthy volunteers, plasma concentrations of tafluorost and its active transformation is Tafluorost acid, under the level of amount of quantity. 0.2 ng/mL, Tafluprost acid: 0.1 ng/ml) At any time, except for a volunteer in the group using a concentration of 0.0025% after eyeed 15 minutes on the first day, with the concentration of Talluprost acid is 0.144 ng/mL. (Note: The concentration of this drug is 0.0015%).

Before taking Taflotan Santen eye drops reduce high eye pressure (2.5ml)

How to use

There is no more than once a day, because more often can reduce the effect of lowering internal pressure (IOP).

about 2 hours to 4 hours after the first drug, the internal pressure begins to decrease, with the maximum effect achieved after 12 hours.

Taflotan® can be used with other eye medications to make the internal pressure lower. If you need to use more than one eye drops, each medication will be at least 5 minutes apart.

When used:

(1) Be careful not to touch the jar directly into the eyes to avoid pills.

(2) Wipe off or wash your face as soon as there is any excess drug that spills into the skin around the eyes.

(3) When taking more than one eye drops, at least 5 minutes from the use of eye drops.

(4) must remove contact lenses before the drug is small because the benzalkonium chloride in the drug can change the color of the lens. Must wait at least 15 minutes before bringing contact lenses back.

Dosage

Put a drop in the eyes, once a day in the evening.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Overdose does not occur when using the drug to shrink eyes. If an overdose occurs, symptomatic treatment.

What to do when forgetting a dose?

Side Effects

When using Taflotan®, you may experience unwanted effects (ADR).

In clinical research, a total of 483 patients participated in clinical research were conducted before the product was approved in Japan. The unwanted effects of the drug (including abnormal changes in testing values) have been reported at 326 out of 483 patients (67.5%). Details are as follows:

Common, ADR> 1/100

Neurological disorders: headache.

Eye disorders: conjunctival conjunctiva, abnormal eyelashes (increase length, thickness and number of eyelashes, etc.), itchy eye, eye irritation, iridal irritation, strange sensation in the eyes, eyelid cell infection, corneal disorders including corneal inflammation, shallow dots, abnormal sensations in the eyes (uncomfortable eyelids, sensation, etc. Phu, V, V ...), eye secretion, fear of light, heavy feeling in the eyes, watery eyes, blurred vision, conjunctiva.

Skin and subcutaneous tissue disorders: Increasing hair growth in the eyelids, erythema.

Testing: Increasing the concentration of potassium in serum, positive proteinuria test, increasing AST (GOT) concentration.

Uncommon, 1/1000

Eye disorders: bleeding under conjunctiva, conjunctivitis, iritis, conjunctivitis, itchy eyelash inflammation (red -eyelid, coverage, etc.), Eye inflammation - Dry corneal, eye irritation, eye pain, abnormal sensation in the eyes (uncomfortable, dry sensation, etc.) above.

Testing, testing: Increasing ALT (GPT), eosinophilia loves EOSIN, reducing the number of white blood cells, increasing gamma-giP concentration, positive urinary tract, increasing uric acid.

After the drug is marketed (at the 5th update of the periodic report on drug safety). A total of 3,260 patients participated in the temporary analysis after the drug was launched in Japan at the 5th update of the periodic report on drug safety. The unwanted effects of the drug have been reported in 396 out of 3,260 patients (12.1%). Details are as follows:

Common, ADR> 1/100

Eye disorders: eyelid pigmentation, conjunctival congestion, corneal disorders include corneal erosion, abnormal eyelashes (increasing length, thickness and quantity of eyelashes, etc.), irisectomy.

Skin and subcutaneous tissue disorders: Increased eyelid growth.

Uncommon, 1/1000

Neurological disorders: headache

Eye disorders: conjunctivitis, itchy eye, lash inflammation (red eyelids, coverage, etc.), Concluding - dry cornea, eye irritation, eye pain, abnormal sensation in the eyes (discomfort, sticky feeling, dry sensation, etc

Rare, 1/10000

Neurological disorders: Dizziness.

Eye disorders: Feeling of strange objects in the eyes, blurred vision, bleeding under conjunctiva, eyelid dermatitis, fear of light, deep eyelid groove, eye extract, conjunctival edema, eye secretion, conjunctiva.

Skin and subcutaneous tissue disorders: rash.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Taflotan® drugs are contraindicated in cases where patients have a history of hypersensitivity to any component of the drug.

Be cautious when using

When using Taflotan® eye drops, you should note the following:

1. Divine infection

Taflotan eye drops have been reported to change pigment tissue. The changes that are often reported are increased iris, eye -catching tissue (eyelid) and eyelashes. The pigment is thought to increase in the use of taflotan® pigmentation changes due to increased amount of melamine in epidermal cells to form melanoma rather than increasing the number of epidermal cells to form dark pigments. After stopping Taflotan®, the pigment of iris is likely to be unchanged, while the pigment changes around the eyes (eyelids) and eyelashes have been recovered and reported in several patients.

Patients treated with taflotan must be told about hyperpigmentation. The long -term effects of hyperpigmentation are not identified. The color change of iris may not be noticeable in months to several years. Typically, the brown pigment around the pupil spreads concentrated towards the peripheral of the iris and the entire iris or part of the iris becomes more brown. Without the pigment, there is no pigment spot of the iris sufficient due to treatment. During treatment, Taflotan® can continue to be used in patients with progressive iris hyperpigmentation, these patients will be examined regularly.

2. Changes of eyelashes

Taflotan® may gradually change eyelashes and fluff in eye treatment. These changes include increasing the length, color, dense, shape and quantity of eyelashes. The changes of eyelashes often disappear completely after stopping the drug.

3. Inflammation

Taflotan® is used cautiously in patients with intraocular infections (such as irocyllitis, uveitis) because inflammation can become more serious.

4. Phu Hoang Diem

The royal switch, including the follicle -shaped point, was reported while treating with Prostaglandin F2A. Taflotan® is used cautiously in patients with a lack of lens, with fake lens with the torn of the following, or patients with risk factors of Phu Hoang Diem.

Do not use taiulost for children because of concerns about safety associated with hyperpigmentation after long -term use.

The ability to drive and operate machinery

Symptoms of temporary blurred vision may occur after taking this drug. It is necessary to guide patients to stop activities such as driving or operating machinery until this symptom is lost.

Pregnancy

Only prescribe this drug for pregnant women or are likely to be pregnant if the estimated treatment benefits are thought to be greater than the risk when taking the drug. [Safety of this drug when used during pregnancy has not been determined]. In animal studies, when using Tafluorost solution, intravenously for rats of pregnancy rats at a dose of 30mg/kg/day (2000 times the clinical dose "), the rate of monitoring and embryo death after the pregnancy increases; at 10mg/kg/day (670 times the clinical dose of clinical doses*), observed the side effect on the development of the fetal fetus). 0.1mg/kg/day (about 6.7 times the clinical dose*), the rate of death and miscarriage after the infection increased, the bodies and the rate of pregnancy decrease; at the dose of 0.03 µg/kg/day (2 times the dose of clinical use*), there was a monster.

In a study of intravenous injection for rats of pregnancy or nursing mothers at a dose of 1mg/kg/day (about 67 times the clinical dose "), the mother rats have been breastfeeding poorly and the survival rate after 4 days decreases. On the other hand, in a study on the culverts of the culverts isolated, observing the uterus at the concentration of about 3.3 times the concentration Tafluorost is not cohesive in plasma (

* Dosage (0.015 mg/kg/day) when dripping (30 Al) this drug in both eyes once for a patient weighs 60 kg.

breastfeeding period

Avoid for women who are breastfeeding. If the drug is considered necessary, it is necessary to guide the patient to stop breastfeeding during treatment. [A study on rats has shown that Tafluprost has gone into breast milk after small eyes.

Drug interaction

There is no interaction that is predicted in humans, when the concentration of tafluprost in the body is very low after the eye small. Therefore, special studies on Tafluorost's interaction with other drugs have not been done. In clinical studies, there is no clear interaction at all when tafluprost has been used simultaneously with Timolol.

Storage

Store at a temperature of not more than 30 ° C in the bottle is closed. Cancel medicine after 1 month.

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