Dexamethasone eye drops, 10ml

Composition

Active ingredient:

dexamethasone sodium phosphate 1 mg;

Auxiliary substances:

polysorbate 80,

hypromellose (hydroxypropylmethylcellulose 4000),

disodium phosphate dodecahydrate,

citric acid monohydrate,

sodium chloride,

disodium edetate dihydrate,

benzalkonium chloride,

purified water.

Pharmacological action

Dexamethasone is a glucocorticoid drug for topical use in ophthalmology. It has anti-inflammatory, anti-allergic and anti-exudative effects.

In target tissues, it interacts with specific protein receptors, regulates the expression of corticoid-dependent genes, and thus affects protein synthesis. Reduces the formation, release, and activity of inflammatory mediators (including histamine, kinin, prostaglandins, and lysosomal enzymes).

Inhibits cell migration to the site of inflammation. Reduces vasodilation and increased vascular permeability in the focus of inflammation. Stabilizes lysosomal enzymes of leukocyte membranes. Inhibits antibody synthesis and disrupts antigen recognition.

Inhibits the release of interleukin 1 and interleukin 2, gamma-interferon from lymphocytes and macrophages. It induces the formation of lipocortin, inhibits the release of inflammatory mediators by eosinophils, and stabilizes mast cell membranes. All of these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical, or immune damage.

The duration of the anti-inflammatory effect of the drug after instillation of 1 drop of the solution is from 4 to 8 hours

. Pharmacokinetics

After instillation in the conjunctival sac, dexamethasone penetrates well into the corneal epithelium and conjunctiva, while therapeutic concentrations are achieved in the watery moisture of the eye. When the mucous membrane is inflamed or damaged, the rate of penetration increases.

Systemic absorption of the drug is minimal. About 60-70% of dexamethasone entering the systemic circulation binds to plasma proteins.

Dexamethasone is metabolized in the liver by Cytocrom Containing enzymes. Metabolites are excreted in the faeces. T_1/2 averages 3 hours.

Indications

Acute and chronic allergic and inflammatory diseases of the eye (including conjunctivitis, scleritis, deep keratitis without epithelial damage, iritis, iridocyclitis, choroiditis, chorioretinitis, optic neuritis), uveitis, episcleritis, blepharitis, scleritis, prevention and treatment of inflammatory processes in the postoperative and post-traumatic period, restoration of corneal transparency and reduction of neovascularization after keratitis, burns.

Use during pregnancy and lactation

The use of the drug during pregnancy during lactation (breastfeeding) is contraindicated.

Use in children

Contraindication: children under 6 years of age.

Contraindications

Side effects

With short-term therapy: nausea, vomiting, bradycardia, arrhythmias, ulceration of the gastrointestinal mucosa, decreased immunity. For long-term use:  Itsenko-Cushing syndrome, hyperglycemia, pancreatitis, myocardial dystrophy, headache, convulsions, psychosis.

Local reactions:  immediately after instillation of the drug, a rapidly passing burning sensation is possible. With prolonged use, intraocular pressure may increase (therefore, when using drugs containing corticosteroids, intraocular pressure should be measured regularly for more than 10 days). If used for more than 3 months, posterocapsular cataracts may develop. Regeneration processes may slow down.

Interaction

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

Dexamethasone may enhance the effect of barbiturates.

The combined use of phenytoin with dexamethasone leads to a decrease in the concentration of the latter.

Warfarin in combination with dexamethasone increases the risk of bleeding.

With the usual topical regimen, the dose is insufficient to induce induction or saturation of liver enzymes.

Concomitant use of dexamethasone with diuretics (especially thiazide and carbonic anhydrase inhibitors) and amphotericin B may increase the excretion of potassium from the body and increase the risk of heart failure.

Concomitant use of dexamethasone with cardiac glycosides worsens their tolerability and increases the likelihood of ventricular extrasystole (due to induced hypokalemia).

Concomitant use of dexamethasone with ethanol and NSAIDs increases the risk of erosive and ulcerative lesions of the gastrointestinal tract.

Estrogens and oral estrogen-containing contraceptives reduce the clearance of dexamethasone, which may be accompanied by an increase in the severity of its action.

The combined use of antiarrhythmic drugs with dexamethasone may lead to a decrease in the effect of the latter.

How to take, course of use and dosage

Into the conjunctival sac. In acute inflammatory processes

• For adults, the drug is instilled into the conjunctival sac 1-2 drops 4-5 times/day for 2 days; in the future, the drug is used 1-2 drops 3-4 times/day for 4-6 days.

For chronic inflammatory processes

• The drug is instilled 2 times / day for 3-6 weeks.

The maximum duration of use of the drug is 6 weeks.

For allergic eye diseases

• The drug is instilled 1-2 drops 4-5 times / day for 2 days with gradual cancellation within 1-2 weeks.

If the eyeball is damaged as a result of injuries or during surgical interventions after an anti-glaucoma filtering operation, the drug is used on the day of the operation or the next day.

After cataract extraction, strabismus surgery, retinal detachment, as well as after trauma, the drug is used starting from the 8th day. Depending on the severity of the symptoms of inflammation, the drug should be instilled 1-2 drops 2-4 times a day for 2-4 weeks.

Children aged 6-12 years in the treatment of allergic and inflammatory conditions are instilled 1 drop 2-3 times a day for 7-10 days. If necessary, treatment is continued after conducting a fluorescein test on day 10 (to check the integrity of the corneal epithelium).

Overdose

Overdose when used in ophthalmology is unlikely.

Symptoms: local manifestations are possible. There is no specific antidote. The drug should be discontinued and symptomatic therapy should be prescribed.

Long-term use of the drug or use in large doses may increase the systemic absorption of dexamethasone, as well as the development of ocular hypertension and certain diseases of the cornea or lens.

Special instructions

The drug should not be used for intraocular injection.

It is intended for topical use only.

Before direct use, the drug should be shaken.

If there is no improvement after 3-4 days of treatment, additional local or systemic treatment should be prescribed.

Do not use the product while wearing soft contact lenses. The drug contains an antimicrobial preservative benzalkonium chloride, which can be adsorbed by soft contact lenses. It is necessary to remove the lenses before applying the drug and install them no earlier than 15 minutes after instillation.

When using the drug in combination with other ophthalmic drops, it is necessary to maintain the interval between instillations of at least 15 minutes.

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

Dexamethasone may result in a false positive doping test result.

Influence on the ability to drive motor vehicles and manage mechanisms

Taking into account the possibility of lacrimation after instillation of the drug, it should not be used immediately before driving vehicles or working with mechanisms. Within 30 minutes after instillation of the drug, it is necessary to refrain from activities that require increased attention.

Form of production

Dexamethasone. Eye drops

Storage conditions

The drug should be stored in a place protected from light, out of the reach of children at a temperature of 15° to 25°C.

Shelf

life is 3 years. After opening the bottle, the drug should be stored for no more than 4 weeks.

Active ingredient

Dexamethasone

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

For adults as directed by your doctor

Indications

Iridocyclitis, Inflammatory eye diseases, Blepharitis, Allergies, Conjunctivitis