Офтан® Dexamethasone

General characteristics. Structure:

Active ingredient: 1,32 mg of dexamethasone of sodium of phosphate that corresponds to 1 mg of dexamethasone.

Excipients: a benzalkoniya chloride, boric acid, sodium pyroborate, dinatrium эдетат, water for and.

Pharmacological properties:

The synthetic fluorinated GKS for topical administration in ophthalmology. Drug has the expressed antiinflammatory and antiallergic effect.

Dexamethasone interacts with specific proteinaceous receptors in target tissues, regulating thus an expression of kortikosteroidozavisimy genes and influencing further protein synthesis. Stabilizes lizosomalny enzymes of membranes of leukocytes and slows down release of enzymes. Slows down synthesis of kinin, a mitosis and migration of leukocytes. Inhibits synthesis of antibodies and breaks antigen recognition. All these mechanisms participate in suppression of inflammatory reaction in fabrics in response to mechanical, chemical or immune destruction.

Duration of antiinflammatory action after an instillation of 1 drop of drug makes 4-8 h.

Pharmacokinetics. Absorption. At topical administration system absorption low. An instillation coxa in a conjunctival sac well gets into an epithelium of a cornea and a conjunctiva. At the same time in watery moisture of an eye therapeutic concentration are reached; at an inflammation or injury of a mucous membrane the speed of a penetration increases.

Distribution and metabolism. About 60-70% of the dexamethasone coming to a system blood stream contact proteins of plasma. Метаболизирустся in a liver under the influence of CYP3A4 isoenzyme.

Removal. Metabolites are removed through intestines. T1/2 averages 3.6±0.9 h.

Indications to use:

Acute and chronic inflammatory processes:

— not purulent forms of conjunctivitis, keratitis, keratoconjunctivitis and blepharitis;

— sclerite and episcleritis;

— iritis, iridocyclitis and other uveites of various genesis;

— superficial damages of a cornea of various etiology (chemical, physical or immune mechanisms) after full epithelization of a cornea;

— inflammation of a back segment of an eye (choroiditis, chorioretinitis);

— hypostasis, an inflammation (including in the postoperative period);

— sympathetic ophthalmia.

Allergic diseases of eyes:

— allergic conjunctivitis or keratoconjunctivitis.

Prevention and treatment of the inflammatory phenomena in the postoperative and posttraumatic period.

Route of administration and doses:

At acute states each 1-2 h appoint 1-2 drops in a conjunctival sac.

After reduction of an inflammation drug is dug in on 1-2 drops in a conjunctival sac of 3-5 times/days.

Duration of treatment should not exceed 2-3 weeks.

The decision on duration of treatment is based on the objective data including efficiency of effect of drug, expressiveness of clinical symptoms and possible risk of emergence of side effects.

Features of use:

Use at pregnancy and feeding by a breast. So far data of clinical tests on use of the drug Oftan® Dexamethasone at pregnancy and in the period of a lactation are absent. Офтан® Dexamethasone can be used at pregnancy and during feeding by a breast only to destination of the attending physician if the expected medical effect justifies potential risk for a fruit and for the child. Therapy duration - no more than 7-10 days.

Use for children. It is contraindicated aged up to 18 years (due to the lack of data on efficiency and safety of use of drug for children and teenagers up to 18 years).

Офтан® Dexamethasone contains in the structure preservative a benzalkoniya chloride which can be absorbed by soft contact lenses and cause change of their color and make an adverse effect on eye tissues. If it is necessary to use contact lenses during treatment by the drug Oftan® Dexamethasone, they should be removed before use of drug and if necessary to establish not earlier than in 15 min. after instillation.

If treatment by drug continues more than 2 weeks, it is regularly necessary to control the intraocular pressure and a condition of a cornea.

Corticosteroid therapy can mask the current bacterial or fungal infections. In the presence of an infection it is necessary to combine use of drops with the corresponding antimicrobic therapy.

Influence on ability to driving of motor transport and to control of mechanisms. In view of possible dacryagogue after an instillation drug is not recommended to be used just before control of vehicles or operation of the mechanical equipment.

Side effects:

From an organ of sight: after an instillation perhaps fast-passing burning sensation, allergic reactions. At prolonged use development of secondary glaucoma and steroid cataract, and also an ulceration, opacification, thinning or/and perforation of a cornea is possible; seldom - spread of bacterial or herpetic infections. Drug contains in the structure preservative a benzalkoniya chloride which can cause irritation of eyes.

Interaction with other medicines:

Interaction with other drugs, is generally caused by participation in CYP3A4 isoenzyme dexamethasone removal. Dexamethasone induces CYP3A4 isoenzyme, thus, reducing efficiency of blockers of calcium channels, quinidine and erythromycin. At the usual mode of topical administration the dose of drug is insufficient to cause induction or saturation of liver enzymes.

At prolonged use with yodoksuridiny strengthening of destructive processes in a cornea epithelium is possible.

Contraindications:

— the keratitis associated with a herpes simplex, chicken pox and other viral diseases of a cornea and conjunctiva;

— tuberculosis of eyes;

— mikobakterialny infections of eyes;

— fungus diseases of eyes;

— acute purulent diseases of eyes;

— damage of an epithelium of a cornea (including a state after removal of a foreign body of a cornea);

— cornea epiteliopatiya;

— the increased intraocular pressure;

— glaucoma;

— age up to 18 years (due to the lack of data on efficiency and safety of use of drug for children and teenagers up to 18 years);

— hypersensitivity to drug components.

Overdose:

The overdose at topical administration of eye drops of Oftan® Dexamethasone is improbable.

Symptoms: perhaps local irritation.

Treatment: there is no specific antidote. Drug it is necessary to cancel and appoint symptomatic therapy.

Storage conditions:

List B. Drug should be stored in the place, unavailable to children, at a temperature from 2 °C to 8 °C. A period of validity – 2 years. After opening of a bottle dropper a period of validity – 1 month.

Issue conditions:

According to the recipe

Packaging:

5 ml - a bottle dropper polyethylene (1) - packs cardboard.