Relestat Allergan solution for treatment and prevention of itchy eye (5ml)

Dosage form Bottle x 5ml
Specifications Epinastine hydrochloride

Ingredient

Composition information	Content
Epinastine hydrochloride	0.5mg/ml

Uses

Indications

Relestat pills are indicated in the following cases:

Treatment and/or prevention of itchy eye related to allergic conjunctivitis in adolescents (12 years old) & adults.

Pharmacokology

Medicines used in scientific eye; Drugs that reduce congestion and anti -allergy drugs; Other anti -allergic drugs.

Epinastine is a direct, locally active and active receptor receptor and is a histamine release inhibitor from moisturizing. Epinastine has a selective activity for H1 histamine receptor and has a affinity for H2 H2 receptor. Epinastine also has affinity for receptors α1-, α2-, and 5-HT2. Epinastine does not absorb through the brain barrier, therefore, there is no ability to cause side effects on the central nervous system.

pharmacokinetics

14 people with allergic conjunctivitis are 1 drops of relatat eye solution every eye, 2 times/day for 7 days. On the 7th, the maximum maximum epinastine concentration in plasma is 0.04 ± 0.014 ng/ml after about 2 hours, showing the concentration of the drug in the whole body is low. While these concentrations show an increase than the concentrations recorded after using a single dose, the value of the area under the curve (AUC) on the 1st and 7th day does not change indicates that there is no increase in body absorption when using multi -dose. Epinastine connects 64% to plasma proteins. The whole body clearance is about 56 liters/hour and the last half -life of plasma is about 12 hours. Epinastine is excreted mainly in constant form. About 55% of the intravenous dosage is found in the form of unchanged urine with about 30% in feces. Under 10% Epinastine is metabolized. Elimination through the kidneys mainly through active excretion in the renal tubules.

Clinical studies

Epinastine HCl 0.05% has shown a clearer substance in improving eye itching in patients with allergic conjunctivitis in clinical studies using two different models:

The model of using conjunctivals (CAC) in which the patient is smaller and then small antigen in the pocket in the same conjunctiva. The results have shown that Epinastine HCl 0.05% has a quick onset within 3 to 5 minutes after using the conjunctiva antigen. The effect time shows that 8 hours, creating the appropriate treatment regime is 2 times/day. This medication mode shows that it is safe and effective for up to 8 weeks without showing signs of a decrease in level.

Before taking Relestat Allergan solution for treatment and prevention of itchy eye (5ml)

How to use

Relestat pills are used in small eyes.

Dosage

recommended dose is a drop in each eye, 2 times/day.

Should continue treatment during the exposure stage (that is, until the pollen season is over or until the exposure to allergens has gone), even without symptoms.

Relestat can be used for teenagers (12 years and older) with the same indications for adults.

There is no experience on clinical research on the use of Relestat for more than 8 weeks. If the patient uses another eye medication, it is advisable to use at least 10 minutes apart.

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?

5 ml relessat bottles contain 2.5 mg of epinastine hydrochloride. The type of tablet has been marketed with oral doses of up to 20 mg of epinastine hydrochologord, 1 time/day, so it is not likely to be poisoned after taking small eye form, even after taking the whole drug in a bottle.

There is no case of overdose.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using relestat drugs, you may experience unwanted effects (ADR).

In clinical studies with Epinastine hydrochloride small eye solution 0.05%, most of the harmful reactions are in the eye and at a mild and serious level.

Side effects ≥ 1.0% from studies with at least 2 weeks of treatment listed below

Side effects related to treatment: eye disorders (burning sensation, eye irritation): 18/489 (3.7%).

Common side effects: eye disorders (burning sensation, eye irritation): 22/489 (4.5%).

Side effects

The ratio of side effects related to treatment and common side effects on 489 patients respectively:

Central nervous system disorders: headache: 3 (0.6%) - 16 (3.3%).

Eye disorders:

conjunctiva conjunctiva: 2 (0.4%) - 4 (0.8%).

Itchy eye: 2 (0.4%) - 3 (0.6%).

visual disorders: 2 (0.4%) - 2 (0.4%). Eye: 1 (0.2%) - 2 (0.4%). dry eyes: 1 (0.2%) - 3 (0.6%).

Respiratory, chest and mediastinum disorders:

Asthma: 2 (0.4%) - 3 (0.6%).

Nose irritation: 1 (0.2%) - 3 (0.6%).

Rhinitis: 1 (0.2%) - 10 (2.0%).

Gastrointestinal disorders:

Change taste: 3 (0.6%) - 3 (0.6%).

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

Relicatch is indicated in the following cases:

Patients with hypersensitivity to epinastine or any ingredients of the drug.

Caution when using

It is necessary to recommend that patients do not carry contact lenses if they are red. Do not use relatat small eye solution to treat eye irritation due to contact lenses. Benzalkonium chloride preservatives in relatat can be absorbed by soft contact lenses.

Patients with soft (water -loving) contact lenses should be instructed on removing contact lenses before relatat and waiting for 10-15 minutes for the solution to penetrate before wearing contact lenses.

The patient should be directed to avoid the head of the vial in contact with the eyes, the area around the eyes, fingers or any other surface to avoid the contamination of the solution due to the common bacteria that cause eye infections. Serious eye damage and vision loss may later be due to the use of contaminated solutions.

Should keep the vials closed when not in use.

Cancer effects, mutations, decline in fertility

In cancer studies according to a diet for 18 months on mice or 2 years on rats, Epinastine does not cause cancer at a dose of up to 40mg/kg (about 30,000 times higher than the maximum recommended dose for eye users is 0.0014 mg/kg/day (MROHD) calculated by mg/kg heavy weight, assuming 100% is absorbed in humans and in animals).The newly synthesized new epinastine logo is not causing mutations in the Ames/Salmonella solution and the In vitro chromosomal trial uses lymphocytes in humans. Recorded positive results with the first epinastine lots in two studies of In vitro chromosomes were conducted in the 1980s using peripheral lymphocytes and V79 cells in humans, respectively. Epinastine produces negative results in chromosomal fractures on live body (in vivo), including small multiplication tests in mice and chromosomal abnormalities in Chinese hamster. Epinastine also produces negative results in the test of cell change using Hamster mouse embryo cells Syrian, mutant testing for using V9/HGPRT mammals cells and DNA synthesis tests without predetermination in Vivo/In vitro using primitive liver cells of mice.

Epinastine does not work on the fertility of male rats. Observed, reducing the fertility in Cai rats when taking oral dose is about 90,000 times the maximum recommended dose for eye users (MROHD).

used in pediatrics

There are no adequate and controlled studies on the effects of relestat on children under 3 years old. Safety in the prescription of Epinastine eye solution has been tested over 96 children aged 3 to 12 years old, and the result is safe & good tolerance. Safety and effectiveness of epinastine for patients> 12 years old have been determined.

Used for the elderly

Relestat has not been studied in patients greater than 65 years old. Research data on safety after the drug is circulated for the form of epinastine hydrochloride tablets (up to a dose of 20 mg once a day) has shown that there is no special problem on safety in elderly patients compared to young adults; Therefore, there is no need to adjust the dose.

The ability to drive and operate machinery

As with any eye drops, if the glimpse is faded at a small drug, the patient should wait until it is clear before driving or using machines.

Pregnancy

In a study of embryo development on pregnant mice, observing toxicity in the mother mouse without effect on embryos at the dose of oral oral content is about 150,000 times the maximum recommended dose for eye users (MROHD). All fetus and miscarriage recorded in an embryo study on pregnant rabbits at an oral dose is about 55,000 times the maximum recommended dose for eye users (MROHD). In both studies, there is no teratogenic effect due to drugs.

Epinastine reduces weight in the child mice after the mother's rats use the dosage of about 90,000 times the doses of recommendations for the maximum of the eye for the eye (MROHD).

However, there are no adequate and well -controlled studies in pregnant women. The safety of Epinastine hydrochloride tablets (10 or 20 mg once a day) has been assessed over 11 pregnant women. No observations of any harmful effects of the drug and no influence of epinastine on pregnant women, giving birth or babies. Because animal reproduction studies do not always be predicted to be met in humans, only small relatat eye solution during pregnancy if the estimated benefits are higher than the risk that may be available to the fetus.

Breastfeeding period

A study on nursing mice has found that epinastine is found through the mother's milk. It is not clear whether this drug is excreted in human milk or not. Because there are many drugs excreted in breast milk, it is necessary to be careful when using a relatat eye solution for breastfeeding women.

Drug interaction

There are no drug interactive studies conducted.

There are no drug -medications that are predicted in humans because of the low -body epinastine level after eye drops. Moreover, in humans, Epinastine is mainly eliminated in a constant form showing a minimum metabolism.

Storage

Store under 30 ° C. Avoid light. Keep the vials closed.

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