Dexamethasone-IES - instructions for use, dose, side effects, contraindications

Active substance:
Dexamethasone sodium phosphate in terms of dry matter	1.0 mg
Excipients:
Boric acid	15.0 mg
Sodium tetraborate decahydrate (sodium tetraborate 10-water)	4.0 mg
Benzethonium chloride	0.04 mg
Disodium edetate (disodium salt ethylenediaminetetraacetic acid)	0.5 mg
1 M sodium hydroxide solution	to pH 7.4-7.8
Purified water	up to 1 ml

Description:Transparent, colorless or slightly colored liquid.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

H.02.A.B.02 Dexamethasone

S.01.B.A.01 Dexamethasone

H.02.A.B Glucocorticoids

S.01.B.A Corticosteroids

Pharmacodynamics:

Dexamethasone is a synthetic fluorinated glucocorticosteroid. Has anti-inflammatory, antiallergic, antiexudative and antipruritic effect. Reduces the permeability of blood vessels, inhibits the migration of leukocytes, phagocytosis, the release of kinins, the formation of antibodies.The anti-inflammatory effect of the drug is 25 times stronger than the action of hydrocortisone.

Pharmacokinetics:

After instillation into the eye it penetrates well into the epithelium of the cornea, therapeutic concentrations are achieved in the aqueous humor of the eye. About 60-70% of dexamethasone entering the systemic circulation is associated with plasma proteins. Dexamethasone when systemic absorption is metabolized in the liver by the action of cytochrome-containing enzymes, metabolites are excreted through the intestine. The half-life period averages 3 hours.

The duration of the local anti-inflammatory effect after instillation of 1 drop of solution into the conjunctival sac is from 4 to 8 hours.

Indications:

Purulent and allergic conjunctivitis, keratitis, keratoconjunctivitis, without damage to the corneal epithelium, iritis, iridocyclitis, Blepharoconjunctivitis, blepharitis, episcleritis, scleritis, inflammation after eye injuries and surgical interventions, sympathetic ophthalmia, corneal transparency reduction and suppression of neovascularization after keratitis, burns (after complete epithelialization cornea).

Contraindications:

Viral, tuberculosis and fungal diseases of the eyes, an acute form of purulent infection in the absence of specific therapy, corneal diseases, accompanied by damage to the integrity of the cornea, hypersensitivity, glaucoma.

Children under 18 years.

Carefully:

Pregnancy, lactation.

Pregnancy and lactation:

Use in pregnant and lactating mothers is possible only for the purpose of the doctor in charge, if the expected therapeutic effect exceeds the risk of developing possible side effects.

Dosing and Administration:

Bury in the conjunctival sac of the affected eye 1 drop 3-5 times a day.

The number of instillations depends on the severity of the inflammatory process.

With severe inflammation, the drug can be used as directed by a doctor for up to several weeks.

Side effects:

Prolonged use of the drug may lead to an increase in side effects.

On the part of the organs of vision: posterior subcapsular cataract; in keratitis with ulceration of the cornea, thinning and perforation of the cornea, development of secondary eye infection, local allergic reactions; increased intraocular pressure,which can lead to the development of glaucoma with optic nerve damage, as well as reduced visual acuity and loss of visual fields.

From the cardiovascular system: arrhythmias, bradycardia, increased blood pressure.

From the nervous system: nervousness, insomnia, dizziness, headache, increased intracranial pressure.

From the digestive system: nausea, vomiting, increased or decreased appetite, exacerbation of chronic diseases of the gastrointestinal tract.

Overdose:

There may be an increase in side effects.

The drug is canceled.

Treatment is symptomatic.

Interaction:

With prolonged use with idoxuridine, it is possible to intensify destructive processes in the corneal epithelium.

Special instructions:

When appointing patients with herpetic keratitis should be borne in mind the possibility of perforation of the cornea.

During treatment (with a duration of more than two weeks), it is necessary to monitor the intraocular pressure and the state of the cornea.

At instillation soft contact lenses should be removed, they can be put on again not earlier than in 15-20 minutes.

Treatment with the drug can mask the picture of a bacterial or fungal infection, so when treating infectious eye diseases the drug should be combined with adequate antimicrobial therapy.

Effect on the ability to drive transp. cf. and fur:Within 30 minutes after instillation, it is necessary to refrain from occupations that require increased attention.

Form release / dosage:Eye drops, 0,1%.

Packaging:

In a tube-dropper for 1.3 ml of 1.5 ml, 2 ml or 5 ml or in bottles of 5 ml.

On 5 tubes-droppers with the instruction on application of a preparation and the instruction on application of a tube-dropper in a pack from a cardboard.

1 bottle with a sterile cap-dropper and instructions for the use of the drug in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 12 to 15 FROM.

Keep out of the reach of children.

Shelf life:

2 years, after opening the bottle - 1 month.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004811/09

Date of registration:18.06.2009 / 20.09.2016

Expiration Date:Unlimited

The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia

Manufacturer: & nbsp

MOSCOW ENDOCRINE FACTORY, FSUE Russia

Information update date: & nbsp21.03.2017

Illustrated instructions

Instructions

Dexamethasone-IES (Dexamethasone-MEZ)