Dexamethasone Bufus of 0,1%

General characteristics. Structure:

Active ingredient: 1 mg of dexamethasone of sodium of phosphate.

Excipients: boric acid, pyroborate sodium decahydrate (sodium tetraborate 10-water), dinatrium эдетат (Trilonum of B), a benzalkoniya chloride, water for injections.

The fluorinated glucocorticosteroid, renders the expressed antiinflammatory, antiallergic and anti-exudative action.

Pharmacological properties:

Pharmacodynamics. Interacting with a specific proteinaceous receptor in target tissues, regulates an expression of kortikoidzavisimy genes and influences, thus, protein synthesis. Reduces education, release and activity of mediators of an inflammation (a histamine, bradikinin, prostaglandins, lizosomalny enzymes). Suppresses migration of cells to the place of an inflammation; reduces a vazodilatation and a hyperpermeability of vessels in the inflammation center. Stabilizes lizosomalny enzymes of membranes of leukocytes; suppresses synthesis of antibodies and breaks antigen recognition. Slows down release interleykina-1 and interleykina-2, interferon scale from lymphocytes and macrophages. Induces formation of a lipokortin, release by eosinophils of mediators of an inflammation oppresses and stabilizes membranes of mast cells.

All these effects participate in suppression of inflammatory reaction in fabrics in response to mechanical, chemical or immune destruction. Duration of antiinflammatory action after an instillation 1 cap of solution makes from 4 to 8 h.

Pharmacokinetics. After an instillation 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. About 60-70% of the dexamethasone coming to a system blood stream contact proteins of plasma.

It is metabolized in a liver under the influence of cytochromium enzymes; metabolites are removed through intestines. The elimination half-life averages 3 h.

Indications to use:

Conjunctivitis (not purulent and allergic), a keratitis, a keratoconjunctivitis (without damage of an epithelium), a blepharitis, a sclerite, an episcleritis, an iritis, an iridocyclitis and other uveites of various genesis, blefarokonjyunktivit, superficial injuries of a cornea of various etiology (after full epithelization of a cornea), prevention of an inflammation after operative measures, a sympathetic ophthalmia.

Route of administration and doses:

The adult at the expressed inflammatory process – within the first 24-48 hours of treatment dig in in a conjunctival sac 1-2 drops each two hours, at reduction of an inflammation – each 4-6 hours.

For prevention of inflammatory processes after eye operations and injuries within the first 24 hours after operation drug is dug in by 4 times a day, further within 2 weeks – 3 times a day.

Features of use:

Use at pregnancy and during breastfeeding. Researches on safety and efficiency of use of dexamethasone for pregnant women and nursing mothers were not seen off. Drug can be used only if the importance of effect for mother exceeds risk of development of side effects of a fruit and the child.

During treatment (lasting more than 2 weeks) it is necessary to control the intraocular pressure and a condition of a cornea.

At an instillation soft contact lenses need to be removed, again it is possible to put on them not earlier than in 15-20 min.

Within 30 min. after instillation it is necessary to abstain from the occupations requiring special attention.

Treatment by drug can mask a picture of a bacterial or fungal infection therefore at treatment of infectious diseases of eyes drug should be combined with adequate antimicrobic therapy.

Side effects:

At prolonged use (more than 3 weeks) increase in intraocular pressure is possible; development of glaucoma with damage of an optic nerve, decrease in visual acuity and loss of fields of vision, and also formation of a back subkapsulyarny cataract, is also possible thinning and perforation of a cornea; very seldom – spread of a herpes and bacterial infection.

At patients with hypersensitivity to dexamethasone or a benzalkoniya to chloride allergic conjunctivitis and a blepharitis can develop. Irritation, itch and burning of skin; dermatitis.

Interaction with other medicines:

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

Contraindications:

Hypersensitivity, children's age (up to 18 years). Viral and fungus diseases of eyes, a purulent infection of eyes (without the accompanying antimicrobic therapy), trachoma, glaucoma, damage of integrity of an epithelium of a cornea (including a state after removal of a foreign body of a cornea); tuberculosis of eyes.

Overdose:

Symptoms: strengthening of the dozozavisimy described side effects is possible.

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

Storage conditions:

In the place protected from light at a temperature from 8 to 15 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Drops eye 0,1%. On 5 ml, 10 ml in bottles from a tube glass. On 5 ml, 10 ml in bottles polymeric with a screw mouth and the screwed cover with the condensing element and a nozzle doser or a nozzle doser with the condensing elements or in bottles polymeric, pressurized by droppers with the screwed covers.

On 1 ml, 1,5 ml, 2 ml, 5 ml, 10 ml in a tube dropper with the valve or a screw mouth from polyethylene of high pressure or from polyethylene of low pressure or from polyethylene for the medical purposes or from polyethylene or polypropylene for infusion solutions and eye drops.

Each bottle or 1, 2, 5, 10 tube droppers with the application instruction place in a pack. The investment in a cover dropper pack is allowed.