VFZ dexamethasone

General characteristics. Structure:

Active agent: dexamethasone of 1 mg/ml

Other ingredients: sodium hydrophosphate, sodium dihydrophosphate, sodium chloride, polysorbate, alcohol, a benzalkoniya chloride, disodium salt of ethylene diamine tetraacetic acid, water for injections.

Pharmacological properties:

Pharmacodynamics. Dexamethasone — GKS with moderate activity having antiinflammatory, antiallergenic and immunosuppressive effect. Influences all phases of inflammatory process. Reduces permeability of blood vessels, suppresses migration of leukocytes, phagocytosis, release of kinin and antibody formation.

Pharmacokinetics. The dexamethasone entered into a conjunctival sac is soaked up in moisture of a chamber of the eye, a cornea, iridescent and vascular covers of an eye, a ciliary body, a retina. From a conjunctival sac the insignificant amount of active agent therefore drug has no systemic action is soaked up.

Indications to use:

Treatment of noninfectious inflammatory and allergic conditions of a conjunctiva, a cornea, a front segment of an eye, sensitive to steroids, including reactions of an inflammation during the postoperative period.

Route of administration and doses:

To apply only in ophthalmology. Before use to stir up a bottle!
The adult, including elderly people — at acute inflammatory process in a conjunctival sac dig in 1–2 drops each 30–60 min. as initial therapy if the effect of treatment positive, then a dose is reduced to 1–2 drops by each 2–4 h, it is possible to lower a dose to 1 drop 3–4 times a day if it is enough for control of process of an inflammation. If the desirable result is not achieved for 3–4 days, additional system or subconjunctival therapy can be appointed.
At chronic inflammatory process in a conjunctival sac each 3–6 h dig in 1–2 drops or are more often if it is necessary.
At an allergy or an insignificant inflammation in a conjunctival sac each 3–4 h before achievement of desirable effect dig in 1–2 drops.
Not to stop therapy prematurely.
After instillation careful closing a century or lacrimonasal occlusion is recommended. It reduces system absorption of the drug administered in an eye which reduces reliability of emergence of system side effects.
In case of the accompanying therapy with use of other local ophthalmologic drugs it is necessary to observe an interval of 10-15 min. between their use.

Features of use:

Drug is intended only for topical administration. At use not to touch a dropper for prevention of contamination of contents of a bottle. Corticosteroids reduce resistance to a bacterial, viral or fungal infection that interferes it with identification. Corticosteroids can mask clinical signs of display of an infection, interfering with detection of inefficiency of antibiotics, or to suppress reactions of hypersensitivity to any of drug components. At permanent formation of helcomas it is necessary to consider a possibility of a fungal infection at patients who were treated or treated by corticosteroids. In case of developing of a fungal infection treatment by corticosteroids needs to be stopped.
Long therapy by corticosteroids can lead to emergence or acceleration of development of a cataract, increase in intraocular pressure in the patients predisposed to it, and to serve in certain cases as the glaucoma reason. Patients with a diabetes mellitus are more inclined to such complications.
If drug is used by patients with glaucoma, treatment needs to be limited to 2 weeks except for cases when lengthening of treatment is justified (however constant control of intraocular pressure of the patient is necessary).
Corticosteroids which apply locally in an eye at frequent use a long time can slow down healing of wounds of a cornea.
During prolonged treatment by dexamethasone it is necessary to check a condition of a cornea the fluorescent test and to control intraocular pressure. In case of positive fluorescent test or the increased intraocular pressure of treatment by drug to stop.
To appoint drug with care to the patients who had a cornea disease with its thinning and scleras as there can be a perforation.
As medicine the benzalkoniya contains in quality of preservative chloride, it can cause irritation, and also decolour soft contact lenses. Therefore during therapy drug does not recommend to carry contact lenses what it is necessary to warn the patient about, or to inform on need to remove contact lenses before use of drug and to wait 30 min. after an instillation before to dress them.
To avoid contact of drug with soft contact lenses.
Not to stop therapy prematurely as the sudden termination of topical treatment by high doses of steroids can lead to a palindromia.
Patients at system or local therapy by corticosteroids which were applied to treatment of other diseases had eye Herpes simplex. Use of corticosteroids during Herpes simplex therapy, except for the epithelial keratitis caused by Herpes simplex for which treatment corticosteroids are contraindicated demands extra care; periodic carrying out conjunctival biomicroscopy using a slit lamp is necessary. During the treatment of a stromal keratitis or a uveitis caused by Herpes simplex to use drug with extra care and only in combination with anti-virus therapy, periodically carrying out biomicroscopy using a slit lamp.
Use during pregnancy and feeding by a breast
To use drug for treatment during pregnancy only if the advantage for mother exceeds potential risk for a fruit.
Not to apply dexamethasone during feeding by a breast as there is a probability of penetration of drug into breast milk. In case of need treatments by drug feeding by a breast should be stopped.
Children
Efficiency and safety of use of drug for children is not established.
Ability to influence speed of response at control of vehicles or work with other mechanisms
Dexamethasone does not influence ability to manage vehicles or to work with other mechanisms. However in connection with possible dacryagogue after an instillation it is not necessary to use drug just before control of vehicles or work with the mechanical equipment until sight is not recovered.

Side effects:

At use of drug it was reported about side reactions which are classified as follows: very frequent (> 1/10), frequent (> 1/100 to <1/10), infrequent (> 1/1000 to <1/100), single (> 1/10 000 to <1/1000), the most rare (<1/10 000) or unknown (it is impossible to estimate the frequency of their emergence). Within each group side reactions are presented as reduction of their severity:
Researches
Infrequent — increase in intraocular pressure.
Disturbances from TsNS
Unknown — dizziness.
Ophthalmologic disturbances
Frequent — thinning of a cornea, pain at the movement of an eyeglobe.
Infrequent — irritation of eyes.
Single — perforation of a cornea of an eye (a visual disturbance, dacryagogue), glaucoma, changes in an optic nerve, a back subkapsulyarny cataract, disorder of sharpness and narrowing of fields of vision (indistinct vision, sight loss), displays of an allergy with localization in eyes, an itch, a mydriasis.
The most rare — a keratitis, a ptosis a century, discomfort and unusual feeling in eyes.
Unknown — a cornea erosion, coloring of a cornea, abnormal sight (zatumanennost), a hyperemia of eyes.
Infectious and parasitic diseases — an eye infection (an aggravation or emergence of consecutive infection).
Right after use of drug there can be a burning, a pricking, an insignificant hyperemia of a conjunctiva, dacryagogue which disappear through 5–15 pages.

Interaction with other medicines:

Not to appoint dexamethasone along with medicines which are applied to treatment of glaucoma especially it is not necessary to apply such combination a long time and in high doses — it can lead to increase in intraocular pressure.
Prolonged use of drug with anticholinergics (especially with atropine and chemicals of similar structure) causes increase in intraocular pressure.
Simultaneous use of dexamethasone with drugs which break accommodation of an eye or expand a pupil, increases risk of increase in intraocular pressure (especially at the patients predisposed to development of the closed angle of filtering).
Use of contact lenses increases risk of infections.

Contraindications:

Hypersensitivity to dexamethasone or to any of drug components. The acute superficial keratitis caused by Herpes simplex; cow, chicken pox and other viral diseases of a cornea and conjunctiva; bacterial infection of an eye. The Mikobakterialny infections of an eye caused, but which are not limited acid-resistant bacteria, such as Mycobacterium tuberculosis, Mycobacterium leprae or Mycobacterium avium. Fungus diseases of structures of an eye. An acute purulent infection of an eye which, as well as other diseases caused by microorganisms can mask or amplify presence of corticosteroids. Corticosteroids should not be applied after uncomplicated removal of a foreign body from an eye, in the presence of the infection or an injury limited to a superficial epithelium of a cornea.

Overdose:

In case of overdose at topical administration to wash up excess of drug from an eye (eyes) warm water. Accidental hit of drug in a GIT does not cause heavy by-effects, it is recommended to accept enough liquid.

Storage conditions:

In the place protected from light at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

Susp. eye. 0,1% фл. - капельн. 5 ml, No. 1.