Restasis eye drops 0.05% allergan increases the ability to produce tears (30 tubes)

Dosage form 30 tube box
Specifications Allergan Sales

Uses

Indications

Restasis ™ is designated to increase tears in patients who are considered to be the loss of tears that have tears due to eye inflammation associated with dry -corn -corn. Increasing tears of tears is not noticeable in patients who are taking anti -inflammatory eye drops or using the rules.

Pharmacokology

Mechanism of action:

Cyclosporine is an immunosuppressant agent when using systemic sugar.

In patients whose tears are thought to be inhibited from eye inflammation associated with dry inflammation - cornea, emulsion cyclosporine is thought to have a local immunosuppressive effect. The exact mechanism of this impact is not known.

Dynamic pharmacokinetics

Cyclosporine A concentration in the blood is quantified by high -performance liquid chromatography. Cyclosporine concentration in the blood, in all samples acquired, after the small Restasis ™ 0.05% 2 times/day in people for 12 months, is below the limit of 0.1 ng/ml. Do not detect the accumulation of drugs in the blood during 12 months of treatment with Restasis ™.

Before taking Restasis eye drops 0.05% allergan increases the ability to produce tears (30 tubes)

How to use

Single -dose single -dose pipe swirls to create uniform white emulsion before use. Small the solution.

Dosage

a drop of Restasis ™ every eye, 2 times a day, about 12 hours.

Series - cornea (dry eye syndrome) is a chronic disease. Patients need advice should not stop treating early.

Restasis ™ can be used simultaneously with artificial tears with a 15 -minute distance between 2 drugs. Should rotate the medicine tube several times to create uniform white emulsion before use. Throw away the medicine tube immediately after use.

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 do

do when using overdose?

Due to the low body absorption cyclosporine concentration after using the eye -catching Restasis ™, therefore is not expected to have a systemic poisoning due to an overdose when using the eye -catching Restasis ™ eye.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

The most common side effect after using Restasis ™ is hot eyes (17%).

Other side effects are reported in 1-5% of patients including:

Nervous system disorders:

Common: headache.

Less: Dizziness.

Very common: hot eyes. Chemistry:

Less: Nausea.

Skin and subcutaneous tissue disorders:

Uncommon: Ban.

After -sales experience:

The rare cases of heavy angioedema, swelling of the face, swelling of the tongue, throat and shortness of breath (Note: These reactions add to the current after -sales event, hypersensitivity reaction).

Notify the doctor with unwanted effects when using the drug.

Warnings

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

contraindicated

Restasis eye drops 0.05% contraindicated in the following cases:

Patients with progressive eye infections and patients who have had a suspicion of hypersensitivity to cyclosporine or any ingredients of the drug.

Be cautious when using

to avoid contamination or the ability to cause eye damage, do not let the tip of the drug touch any surface and avoid contact with the eyes.

Restasis ™ has not been fully studied in patients with a history of relapse of Christmas Indisse.

The emulsion in a disposable medicine tube for a patient should be used immediately after opening it to a small or both sides of the eye, and the excess medicine should be thrown away after the drug.

To avoid the possibility of causing eye damage, be careful not to touch the eye. Do not let the tip of the medication touch the eye or any other surface to avoid contamination.

restasis ™ should not be used when wearing contact lenses. If you are carrying contact lenses, patients should remove before the emulsion.

Can bring glasses back about 15 minutes after the Restasis ™.

Cancer ability, mutations and fertility reduced

Studies on the possibility of body cancer have been conducted on mice and male and female rats.

In a 78 -week study in the mouse, which is given by a diet (according to a diet), a dose of 1.4 and 16mg/kg/day, acknowledged evidence of the statistical significance of the tendency of lymphocytic cells in female mice, and the rate of liver cell cancer significantly exceeds the controlled value in male mice when taking half the dose.

In a 24 -month study in the mouse, drinking (according to a diet) dose of 0.5; 2 and 8mg/kg/day, pancreatic cell gland tumor exceeds significant control at low doses. Cancer of liver cells and pancreatic cell glands are not related to the dose.

Low doses in mice are about 300 times higher and in mice about 80 times higher (standardized by body surface area) compared to daily doses in humans, or another way, low doses in mice are about 1,000 times higher and in rats about 500 times higher than the daily dose in humans is a drop of (28 µl) Restasis ™ 2 times/day on each person's eye 601) The whole dose is absorbed.

Cyclosporine is not considered a gene mutation in the AMES test, V79-HGPRT test, small kernel test in Chinese mice and Chinese hamster rats, testing of chromosomal disorders in Chinese hamster bone marrow, testing dominant death in mice and testing for DNA repair in semen epidemics of being treated.

A chromosome exchange analysis study in the same form (SCE - Sister Chromatid Exchange) causes an induction with cyclosporine by using lymphocytes in Vitro tests that gives signs of positive results (SCE induction method).

There is no decline in fertility in studies in male and female rats when taking Cyclosporine oral doses up to 15 mg/kg/day (about 15,000 daily dose in humans 0.001 mg/kg/day) for 9 weeks (male mice) and 2 weeks (female mice) before mating.

for children

The safety and effectiveness of Restasis ™ has not been verified in children under 16 years old.

for the elderly

Overall, there is no difference in safety and effectiveness between old and young patients.

Women during pregnancy and lactation

Women during pregnancy should take medicine?

Pregnant women group c.

There is no adequate data on the use of Restasis ™ in pregnant women. The 0.05% small cyclosporine eye mixture is not absorbed the whole body after use at the eye and the use of the mother is not expected to lead to the fetus exposure.

Animal studies have shown reproductive toxicity only at high doses of toxic to mother animals.

The teratogenic effect:

Not observing evidence of the teratogenic effect in mice or rabbits taking oral doses of cyclosporine up to 300mg/kg/day during the formation of organs.

This dose in rats and rabbits is about 300,000 times higher than the daily dosage in humans as a drop (28 µl) Restasis ™ 0.05% small 2 times/day on each eye of a person weighing 60 kg (0.001 mg/kg/day), assuming the entire dose is absorbed.

The non -teratogenic effect:

The side effects are observed in reproductive studies in rats and rabbits only at toxic doses for mother objects.

At the toxic dose (in mice is 30 mg/kg/day and in rabbits is 100 mg/kg/day), oral cyclosporine solution meets the US standard toxic to the embryo and fetus manifests itself through the increase in the increase of money - postpartum and reducing the fetal weight combined with slow bone formation.

These doses in rats are 30,000 times higher and in rabbits 100,000 times higher than the daily dosage in humans is a drop (28 µl) Restasis ™ 0.05% small/day into each eye of a person weighing 60 kg (0.001 mg/kg/day), assuming the whole dose is absorbed.

No observations of evidence of embryo toxicity in mice culverts using cyclosporine oral doses up to 17mg/kg/day or rabbits use Cyclosporine oral dosage up to 30mg/kg/day during the formation of agencies.

Dosage in rats is about 17,000 times higher and the dose in rabbits is about 30,000 times higher than the daily dose in humans.

The child's child's life is given Cyclosporine 45 mg/kg/day from the 15th day of pregnancy to the 21st postpartum, at the level of poisoning for the mother rat, showing an increase in post -proliferation; This dose is 45,000 times higher than the daily dosage of human eye (0.001mg/kg/day), assuming the whole dose is absorbed.

There is no side effects observed at oral dose up to 15 mg/kg/day (15,000 times higher than the daily dose in humans).

There is no adequate and well -controlled research on Restasis ™ in pregnant women. Restasis ™ should only be used for pregnant women when really necessary.

Should

Women breastfeeding should take medicine?

Cyclosporine is known to have excretion on breast milk after using systemic sugar, but the excretion of breast milk after local treatment has not been studied. Although the blood concentration has not been detected after using Restasis ™ on the spot, should be cautious when using Restasis ™ for women who are breastfeeding.

The ability to drive and operate machinery

Restasis ™ can cause faint blurring, which can reduce driving or operating machinery. Patients should wait until they are clear before driving or operating machinery.

Drug interaction

While drugs that have been known to the metabolism of P-450 have been known to cause a change of body cyclosporine metabolism, the whole body exposure of Restasis ™ (cyclosporine eye small emulsion) is a minimum. Therefore, it is not sure if any interaction occurs between Restasis ™ eye drops and systemic drugs.

There is little information on the interaction between eye drops when used with cyclosporine eye drops.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

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