Instruction for use: Dexapos

Active substance: Dexamethasone

ATX Code S01BA01 Dexamethasone

Pharmacological group

Glucocorticosteroid for topical use [Glucocorticosteroids]

Glucocorticosteroid for topical use [Ophthalmic products]

The nosological classification (ICD-10)

H10.1 Acute atopic conjunctivitis

Allergic conjunctivitis, Allergic eye disease, Allergic conjunctivitis, Allergic conjunctivitis is caused by chemical and physical factors, Allergic rhinoconjunctivitis,Allergic inflammation of the eye, Spring catarrh, Spring keratitis, Spring conjunctivitis, allergic Conjunctivitis, Perennial allergic conjunctivitis,Exacerbation of pollen allergy in the form of Syndrome rinokonyunktivalnogo, Acute allergic keratoconjunctivitis, Acute allergic conjunctivitis,Superficial bacterial eye infections,rhinoconjunctivitis, Seasonal allergic conjunctivitis, Seasonal conjunctivitis, Sennoz, Chronic allergic keratoconjunctivitis, Chronic allergic conjunctivitis

H10.3 Acute conjunctivitis, unspecified

Acute conjunctivitis

H10.4 Chronic conjunctivitis

Chronic allergic conjunctivitis, Chronic inflammation of the conjunctivam, Papillary conjunctivitis, Phlyctenular keratoconjunctivitis

H10.9 Conjunctivitis, unspecified

Trahomny conjunctivitis, catarrhal conjunctivitis, Giperpapillyarny conjunctivitis, Non-infectious conjunctivitis, purulent conjunctivitis, Purulent conjunctivitis form, Year-round conjunctivitis, purulent conjunctivitis, Subacute conjunctivitis, Secondarily infected with conjunctivitis

H15.0 Sclerite

Acute scleritis, Chronic scleritis, Diffuse scleritis, Sclerite

H16 Keratitis

Adenoviral keratitis, Bacterial keratitis, Spring keratitis, Deep keratitis without epithelial damage, Discoid keratitis, Dendritic keratitis, Keratitis rosacea, Keratitis with destruction of the cornea, Superficial keratitis, Point keratitis, Traumatic keratitis, Superficial point keratitis

H16.2 Keratoconjunctivitis

Chronic allergic keratoconjunctivitis, Bacterial keratoconjunctivitis, Deep forms of adenovirus keratoconjunctivitis, Infectious conjunctivitis and keratoconjunctivitis caused by Chlamydia trachomatis, Acute allergic keratoconjunctivitis, Spring keratoconjunctivitis, Phlyctenular keratoconjunctivitis

H18 Other diseases of the cornea

Keratopathy

H20 Iridocyclitis

recurrent iritis, sympathetic iridocyclitis, Sluggish posterior uveitis, Sluggish posterior uveitis, Posterior uveitis, the posterior segment of the eye Iridocyclitis, Iridocyclitis and other uveitis, Irit, Keratoiridotsiklit, Acute iritis, uveitis, cycle of Acute iridocyclitis, Acute non-infectious uveitis

H20.0 Acute and subacute iridocyclitis

H20.1 Chronic iridocyclitis

Chronic iritis

H20.9 Iridocyclitis Unspecified

Iridocyclitis, Diffuse posterior uveitis, keratouveit, Uveitis middle or rear portion of the eye, Sight-threatening uveitis middle or rear portion of the eye,keratouveitis, Anterior uveitis, Flaccid anterior uveitis, Endogenous uveitis, Inflammation of the ciliary body, Uveitis anterior portion of the eyeball, sympathetic uveitis

H30 Chorioretinal inflammation

Retinitis, Chorioretinitis, Central and peripheral chorioretinal dystrophy

H30.9 chorioretinal inflammation, unspecified

Choroiditis, myopic chorioretinitis, Violation of choroidal circulation, Central retinitis

H44.1 Other endophthalmitis

Ophthalmic sympathetic, Egyptian ophthalmia,Endophthalmitis

H45.1 Endophthalmitis in diseases classified elsewhere

Sympathetic ophthalmitis

S05 Injury of the eye and orbit

Wounds of the eye penetrating, Non-penetrating wound of the eyeball, Superficial injury of the cornea, Post-traumatic keratopathy, Post-traumatic central retinal dystrophy, Penetrating wound of the cornea, Condition after eye injuries, Condition after eyeball injuries, Penetrating corneal wounds, Injuries to eye tissues, Injuries to the cornea, Injury of anterior part of eye

T88 Other complications of surgical and therapeutic interventions, not elsewhere classified

Z98.8 Other specified poslehirurgicheskie state

Suppurative complications in the postoperative period, Suppurative complications of surgery, Postoperative liver dysfunction, Postoperative vomiting, Postoperative complications, The postoperative period, The early postoperative period

Composition

Eye drops 1 ml

active substance:

Dexamethasone sodium metasulfobenzoate 1 mg

Auxiliary substances: thiomersal - 0.05 mg; Hypromellose - 5 mg; Dextrose monohydrate - 50 mg; Water for injection - up to 1 ml

Description of dosage form

Solution: clear, colorless or slightly yellowish.

pharmachologic effect

Pharmacological action - anti-inflammatory, antiallergic, glucocorticoid.

Pharmacodynamics

GCS (glucocorticosteroids), has a pronounced anti-inflammatory, anti-allergic and anti-exsudative action.

Interacting with a specific protein receptor in target tissues, regulates the expression of corticoid-dependent genes and thus affects the synthesis of the protein. Reduces the formation, release and activity of inflammatory mediators (histamine, bradykinin, PG (prostaglandins), lysosomal enzymes). Suppresses the migration of cells to the site of inflammation; Reduces vasodilation and increased vascular permeability in the focus of inflammation. Stabilizes lysosomal enzymes of leukocyte membranes; Suppresses the synthesis of antibodies and disrupts the recognition of the antigen. Inhibits the release of IL (interleukin) -1 and IL (interleukin) -2, γ-interferon from lymphocytes and macrophages. Induces the formation of lipocortin, inhibits the release of eosinophils mediators of inflammation and stabilizes the membranes of mast cells. All these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical or immune damage. The duration of anti-inflammatory action after instillation of 1 drop of solution is 4-8 hours.

Pharmacokinetics

After instillation in 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; With inflammation or damage to the mucous membrane, the penetration rate increases. About 60-70% of dexamethasone entering the systemic circulation is associated with plasma proteins. Metabolised in the liver by the action of cytochrome-containing enzymes; Metabolites are excreted through the intestine. T1 / 2 is an average of 3 hours.

Indications

Acute and chronic inflammatory processes:

- Inflammation of the anterior segment of the eye (nasal conjunctivitis, scleritis, deep keratitis without epithelial damage, iritis, iridocyclitis and other uveitis of various origins);

- inflammation of the posterior segment of the eye (choroiditis, chorioretinitis);

- sympathetic ophthalmia;

Prevention and treatment of inflammatory phenomena in the post-operative and post-traumatic period;

Allergic eye diseases:

- allergic conjunctivitis and keratoconjunctivitis.

Contraindications

Hypersensitivity to any of the components of the drug;

Keratitis caused by Herpes zoster (dendritic keratitis), chicken pox and other viral diseases of the cornea and conjunctiva;

Mycobacterial infections of the eyes;

Fungal diseases of the eyes;

trachoma;

Bacterial infections of the eyes (without concomitant antimicrobial therapy);

Acute purulent diseases of the eyes and eyelids with defeat of the corneal epithelium;

Corneal epitheliopathy;

Increased intraocular pressure;

Immunosuppression;

Children's age till 18 years.

pregnancy and lactation

Dexamethasone can be used during pregnancy and lactation as prescribed by the treating doctor only if the expected curative effect justifies the potential risk to the fetus and the baby. In the first 3 months of pregnancy the drug should be administered with extreme caution, taking into account the risk of possible violations of fetal development in animal experiments (wolf mouth).

Side effects

After instillation of eye drops Dexapos may occur dermatitis, eye irritation, foreign body sensation, tingling, itching and burning sensation in the eye.

In patients with hypersensitivity to the components of the drug may develop allergic conjunctivitis and blepharitis.

Rarely - mydriasis, ptosis and transient disorders of accommodation.

Long-term use of the drug (more than 14 days) can cause increased intraocular pressure, the emergence of secondary glaucoma with optic nerve damage, reduced visual acuity and loss of visual fields. It is also possible to form a posterior subcapsular steric cataract and thinning and perforating the cornea; Occurrence of iritium.

Interaction

When combined with atropine, other cholinergic or mydriatic drugs, an increase in the level of intraocular pressure is possible.

Interaction with other drugs is mainly due to the participation in the excretion of dexamethasone cytochrome P450 (CYP3A4 (cytochrome P450 isoenzyme)) containing enzymes. It induces the enzyme CYP3A4; Reducing the effectiveness of CCB (calcium channel blockers), quinidine and erythromycin. In the usual topical regimen, the dose of the drug is not sufficient to induce induction or saturation of the liver enzymes.

With prolonged use with iodoxuridine, destructive processes in the epithelium of the cornea can be intensified.

Dosing and Administration

In the conjunctival sac.

Pronounced inflammatory process: during the first 24-48 hours of treatment, 1-2 drops every 2 hours, with reduction of inflammation - every 4-6 hours.

The duration of treatment usually does not exceed 2 weeks.

Prevention of inflammatory processes in ophthalmic surgery: during the first 24 hours after eye operations.

Overdose

Unlikely.

special instructions

Before instillation of the drug, it is recommended to remove contact lenses and re-put them no earlier than 20 minutes after instillation.

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.

When treating the drug for more than 10 days, it is necessary to regularly monitor the intraocular pressure and the condition of the cornea.

Drops containing GCS (glucocorticosteroids), with prolonged use, can cause a decrease in the rate of wound healing, bullous changes in the cornea.

Influence on the ability to drive vehicles and work with machinery. Immediately after the application of eye drops Dexapos, a brief disturbance of visual acuity may occur, it is not recommended to drive the car and engage in activities requiring increased attention until its recovery.

Form of issue

Eye drops, 0,1%. In PE (polyethylene) flasks-droppers with a screwed protective cap, equipped with a safety ring, 5 ml each. 1 bottle-dropper in a pack of cardboard.

Terms of leave from pharmacies

On prescription.

storage conditions

At a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life

2 years. After opening - 4 weeks.

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