Dexamethasone treatment - instructions for use, doses, side effects, contraindications

Excipients: Benzalkonium chloride 0.1 mg, potassium chloride 1.4 mg, sodium chloride 3.6 mg, disodium edetate dihydrate 0.5 mg, hypromellose 3 mg, potassium dihydrogen phosphate 3.63 mg, sodium hydrogen phosphate dodecahydrate 7.13 mg, macrogol 4000 30.0 mg, water purified to 1.0 ml.

Description:Transparent, colorless or slightly yellowish 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 a pronounced anti-inflammatory, anti-allergic and anti-exsudative action.

Interacting with the glucocorticoid receptors in the nucleus of the cell, regulates the expression of corticoid-dependent genes and thus influences the synthesis of proteins. Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, prostaglandin, lysosomal enzymes).Suppresses the migration of cells to the site of inflammation; reduces vasodilation and increased vascular permeability in the focus of inflammation. Stabilizes the lysosomal enzymes of leukocyte membranes, inhibits the synthesis of antibodies and disrupts the recognition of the antigen. It inhibits the release of interleukin 1 and interleukin 2, interferon gamma from lymphocytes and macrophages. It induces the formation of lipocortin, inhibits the release of eosinophils by inflammatory mediators and stabilizes the membranes of mast cells. All these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical and immune damage.

The duration of anti-inflammatory action after instillation of 1 drop of solution is from 4 to 8 hours.

Pharmacokinetics:

With topical application, systemic absorption is low. After instillation into the conjunctival sac it penetrates well into the epithelium of the cornea and conjunctiva; while in the aqueous humor of the eye, therapeutic concentrations are achieved; When inflammation or damage to the mucosa, the penetration rate increases. About 60-70% of dexamethasone entering the systemic circulation communicates with plasma proteins.Metabolised in the liver by the action of microsomal liver enzymes; metabolites are excreted through the intestine. The half-life period averages 3 hours.

Indications:

Allergic eye diseases:

- allergic conjunctivitis or keratoconjunctivitis.

Acute and chronic inflammatory eye diseases:

- non-nasal forms of conjunctivitis, keratoconjunctivitis, keratitis (without epithelial damage);

- scleritis, episcleritis;

- blepharitis, blepharoconjunctivitis;

- irit, iridocyclitis and other uveitis of various genesis;

- superficial injuries of the cornea of various etiologies (after complete epithelialization of the cornea);

- sympathetic ophthalmia.

Prevention of inflammation after surgery.

Contraindications:

- Hypersensitivity to individual components of the drug;

- viral and fungal diseases of the cornea and conjunctiva;

- acute purulent diseases of the eyes with defeat of the corneal epithelium;

- trachoma;

- glaucoma;

- damage to the integrity of the corneal epithelium;

- tuberculosis of the eye;

- condition after removal of the foreign body of the cornea;

- Children's age under 18 years (due to the lack of data on the effectiveness and safety of the drug in children and adolescents under 18 years).

Pregnancy and lactation:

Dexamethasone lang® can be used during pregnancy and lactation as prescribed by the doctor if the expected therapeutic effect for the mother justifies the possible risk to the fetus and the baby.

Dosing and Administration:

With severe allergic eye diseases or a pronounced inflammatory process - during the first 24-48 hours of treatment, 1-2 drops of 0.1% solution are injected into the conjunctival bag every 2 hours, with a decrease in inflammation - every 4-6 hours.

For the prevention of inflammatory processes after eye operations and injuries during the first 24 hours after the operation, the drug is digested 4 times a day, then for 2 weeks - 3 times a day.

The duration of treatment should not exceed 2-3 weeks.

Side effects:

Immediately after instillation, there may be an unclear vision.

With prolonged use of the drug (more than 3 weeks), it is possible to increase intraocular pressure, the development of glaucoma with optic nerve damage, decreased visual acuity and loss of visual fields, as well as the formation of posterior subcapsular cataracts, and possibly thinning and perforation of the cornea; spread of herpetic and bacterial infection.

In patients with hypersensitivity to dexamethasone or benzalkonium, chloride may develop allergic conjunctivitis and blepharitis.

Irritation, itching and burning of the skin around the eyes; dermatitis of the eyelid skin.

Overdose:

With topical application of the drug, an overdose is unlikely.

Symptoms: possibly local irritation.

There is no specific antidote. The drug should be canceled and symptomatic therapy prescribed.

Interaction:

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

Special instructions:

During treatment (with a duration of more than 2 weeks), it is necessary to monitor the intraocular pressure and the condition of the cornea.

Treatment with the drug can mask the picture of a bacterial or fungal infection.

Contact lenses are removed before the instillation of the drug and set again no earlier than 15-20 minutes after instillation.

Effect on the ability to drive transp. cf. and fur:Within 30 minutes after instillation of the drug, it is necessary to refrain from occupations requiring increased attention, including driving.

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

Packaging:

For 5 and 10 ml in plastic bottles with a dispenser - a dropper.

1 bottle with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

2 years.

The opened vial should not be stored for more than 30 days.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-002124

Date of registration:04.07.2013

Expiration Date:04.07.2018

The owner of the registration certificate:FIRN M, ZAO FIRN M, ZAO Russia

Manufacturer: & nbsp

FIRN M, ZAO Republic of Belarus

Information update date: & nbsp22.03.2017

Illustrated instructions

Instructions

DexamethasoneLong® (DexamethasonLong®)