Софрадекс

General characteristics. Structure:

Active agents: Framycetinum sulfate of 5 mg; gramicidin of 50 mkg; dexamethasone (in the form of metasulfobenzoate sodium) 500 mkg.

Excipients: a lity chloride, sodium citrate, citric acid monohydrate, фенилэтанол, ethanol of 99.5%, polysorbate 80, water for injections.

Pharmacological properties:

Pharmacodynamics. Софрадекс - the combined drug, possesses antibacterial, antiinflammatory and antiallergic action.

Framycetinum sulfate - the antibiotic from group of aminoglycosides, works bakteritsidno. Possesses a wide range of antibacterial action, it is active concerning gram-positive microorganisms, including golden staphylococcus, and the majority of clinically significant gram-negative microorganisms (colibacillus, a stick of a diznteriya, proteas, etc.). It is ineffective concerning steptokokk. Does not affect a pathogenic fungi, viruses, anaerobic flora. Stability of microorganisms to Framycetinum to sulfate develops slowly. Gramicidin - has bactericidal and bacteriostatic effect, expands a range of antimicrobic action of Framycetinum due to the activity concerning stafilokokk as too has antistaphylococcal effect.

Dexamethasone - GKS rendering expressed antiinflammatory, the antiallergic and desensibilizing action. Dexamethasone suppresses inflammatory processes, oppressing emission of mediators of an inflammation, migration of mast cells and reducing permeability of capillaries. At an instillation in eyes will reduce pain, burning, dacryagogue, a photophobia. At an instillation in ears reduces symptoms of otitis of an outside ear (erubescence, pain, an itch, burning in outside acoustical pass, feeling of a congestion of an ear).

Pharmacokinetics. At topical administration system absorption low.

Framycetinum sulfate can be soaked up through the inflamed skin or open wounds. At receipt in a system blood stream he is quickly brought by kidneys in not changed look. T1/2 of Framycetinum of sulfate makes 2-3 h.

At intake dexamethasone is capable to be absorbed quickly from a GIT. T1/2 makes 190 min.

Indications to use:

- bacterial diseases of a front piece of an eye;

- blepharites;

- conjunctivitis;

- a keratitis (without damage of an epithelium);

- iridocyclites;

- sclerites, episclerites;

- the infected skin eczema a century;

- otitis of an outside ear.

Route of administration and doses:

At diseases of eyes:

at the easy course of infectious process each 4 h dig in 1-2 drops of drug of Sofradeks in a conjunctival sac of an eye. In case of development of heavy infectious process drug is dug in each hour. In process of reduction of the inflammatory phenomena the frequency of instillations of drug decreases.

At ear diseases:

dig in 2-3 drops of 3-4 times/days, in outside acoustical pass it is possible to put the gauze tampon moistened with solution of Sofradeks.

Duration of use of drug should not exceed 7 days, except cases of explicit positive dynamics of a disease (GKS can mask it is hidden the proceeding infections, and long use of antimicrobic components of drug of Sofradeks to promote development of steady flora).

Features of use:

At prolonged use of drug of Sofradeks, as well as at prolonged use of other antimicrobic means, development of the superinfections caused by microorganisms, steady against drug, including fungi is possible.

The long instillation of drugs of an eye can lead to thinning of a cornea with development of its perforation, and also to increase in intraocular pressure. Treatment by the drugs containing corticosteroids should not is carried out repeatedly or is long without regular control of intraocular pressure, inspection of eyes regarding development of a cataract or consecutive infections.

Local GKS never have to be applied at patients with a hyperemia of an eye of an unspecified eliologiya since inappropriate use of drug can lead to znachiyelny deterioration in sight.

The sulfate which is a part of drug of Sofradeks of Framycetinum is an antibiotic from group of aminoglycosides to which development nefro-and ototoksichesky effects is peculiar at system use or local drawing on an open wound or the injured skin. These effects depend on a dose and increase also a renal or liver failure. Though development of these effects was not observed at a drug zakapyyvaniye in eyes, it is necessary to take into account a possibility of their emergence in case of topical administration of high doses of drug at children.

Duration of use of drug should not exceed 7 days, except cases of explicit positive dynamics of a disease since long use of GKS which is its part can mask is hidden the proceeding infections, and long use of antimicrobic components - to promote development of steady flora.

Influence on ability to driving of motor transport and to control of mechanisms.

Patients at whom after an instillation in an eye of drug sight clearness is temporarily lost are not recommended to drive the car right after an instillation of drug or to work with a difficult technique, machines or any other difficult equipment demanding sight clearness.

The bottle needs to be closed after each use. It is not necessary to touch with a pipette tip an eye. After opening of a bottle drug should be used within 1 month.

Side effects:

The allergic reactions of usually delayed type which are shown irritation, burning, pain, an itch, dermatitis.

At prolonged use of corticosteroids of local action it is possible: increase in intraocular pressure with development of a symptom of a complex of glaucoma (damage of an optic nerve, decrease in visual acuity and emergence of defects of fields of vision) therefore at more than 7-day use of the drugs containing glucocorticosteroids it is necessary to measure intraocular pressure regularly; development of a back supkapsulyarny cataract (especially at a frequent instillation); thinning of a cornea or sclera which can lead to perforation; accession of a consecutive (fungal) infection.

Interaction with other medicines:

It is not necessary to apply Framycetinum sulfate together with other antibiotics having ototoksichesky and nephrotoxic effect (streptomycin, Monomycinum, Kanamycinum, gentamycin).

Contraindications:

— the increased individual sensitivity to any of components of drug of Sofradeks;

— viral or fungal infections, tuberculosis, purulent inflammation of eyes, trachoma;

— disturbance of integrity of an epithelium of a cornea and thinning of a sclera;

— a herpetic keratitis (a treelike helcoma) (increase in the sizes of an ulcer and considerable deterioration in sight is possible);

— glaucoma;

— perforation of a tympanic membrane (penetration of drug into a middle ear can lead to development of ototoksichesky action);

— pregnancy and period of feeding by a breast;

— children of chest age.

With care: to children of younger age (especially at purpose of drug in high doses it is also long - risk of development of sistemy effects and suppression of function of adrenal glands).

Overdose:

Long and intensive local use can lead to emergence of system effects. Symptomatic treatment.

At a proglatyvaniye of contents of one bottle (to 10 ml of solution) development of serious side effects is improbable.

Storage conditions:

In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Eye/ear drops: bottle of 8 ml or 5 ml.

On 1 bottle together with a dropper from polyethylene and the instruction on a medical use in a cardboard pack.