Фармадекс

General characteristics. Structure:

Active ingredient: dexamethasone;

1 ml contains dexamethasone of sodium of phosphate of disodium salt 1 mg;

excipients: boric acid, sodium pyroborate, dinatrium эдетат, a benzalkoniya chloride, water for injections.

Pharmacological properties:

Pharmacodynamics. Dexamethasone - a synthetic glucocorticoid with the expressed antiinflammatory and antiallergic activity, high-soluble, with quick start and short duration of action.

Pharmacokinetics. At instillation in an eye drug gets into all okologlazny fabrics. It is metabolized preferential in an injection site. Almost does not get into a system blood stream.

Pharmaceutical characteristics.

Main physical and chemical properties: transparent colourless liquid.

Indications to use:

Treatment of noninfectious inflammatory and allergic conditions of a conjunctiva, cornea and a front segment of an eye, sensitive to steroids; inflammatory processes after injuries of an eye and surgical intervention.

Route of administration and doses:

It is applied at adults and it is intended only for ophthalmologic use.

At serious or acute conditions it is necessary to dig in 1–2 drops in a conjunctival sac of the affected eye each 60 minutes. At improvement of a state frequency rate of instillations is reduced to 1–2 drops by each 2–4 hours. Then the dose is reduced to 1 drop by 3–4 times a day.

At chronic diseases dig in 1–2 drops in a conjunctival sac of the affected eye each 3–6 hours or is more often before achievement of desirable effect.

At allergic states 1–2 drops each 3–4 hours before achievement of desirable effect.

Duration of treatment is established by the doctor individually, averages from 2 to 9 days.

Features of use:

Attention! Prior to use densely not to screw up a cap! Before the first use the cap of a bottle is screwed up as much as possible. At the same time the thorn which is on the cap interior punctures an opening. Just before use it is necessary to take a bottle with drug in a palm to warm up it to body temperature. The cap is unscrewed, removed and, slightly pressing on the bottle case, dig in solution in an eye. After a drug instillation the cap is densely screwed up and store drug according to the recommendations provided in the instruction.

Prolonged use of corticosteroids or increase in frequency of reception can lead to eye hypertensia / глаукоми with injury of an optic nerve and deterioration in visual acuity and loss of a field of vision, and also to formation of a subkapsulyarny cataract of a back chamber of the eye.

After use of usual doses for sensitive patients intraocular pressure can increase. It is recommended to control intraocular pressure constantly.

Patients with glaucoma with drug should limit treatment two weeks except for cases when the prolonged treatment is justified. It is necessary to control intraocular pressure constantly.

At prolonged use of steroids can develop:
fungal infections of a cornea (development of a fungal invasion at any permanent formation of helcomas is possible);
the consecutive bacterial infection of an eye can arise at oppression of reaction of an organism to an infection;
to mask or increase activity of acute purulent infections of an eye;
against the background of steroid therapy of a disease which lead to thinning of a cornea or sclera can lead to perforation;
delay of healing of wounds of a cornea.

Treatments should not be stopped prematurely as the sudden termination of topical treatment by high doses of steroids can cause a repeated inflammation of an eye.
Eye drops of Pharmadeks contain preservative a benzalkoniya chloride which can lead to irritation of eyes and decolour soft contact lenses. Therefore before use of drug of Pharmadeks patients have to remove contact lenses and have to be informed on what needs to be waited for 15 minutes after Pharmadeks's instillation before inserting contact lenses.

Safety of use of Pharmadeks it was not investigated at patients who have diseases of kidneys or a liver. However through low system absorption of dexamethasone, after topical administration of this drug, in dose adjustment there is no need.

Ability to influence speed of response at control of motor transport or in operating time with other mechanisms. As well as in case of use of other eye drops, the temporary illegibility of sight or other vision disorders can influence ability of control of motor transport or mechanisms. If the illegibility of sight arises at an instillation, the patient needs to wait until sight is recovered before managing motor transport or during the work with other mechanisms.

Side effects:

Disturbance from an organ of sight: perhaps short-term burning sensation, discomfort in an eye, an itch, a pricking, a hyperemia, dacryagogue, local allergic reactions, hypostasis and an itch a century, is possible decrease in visual acuity, disturbance of fields of vision, increase in intraocular pressure, perforation of a cornea (at its thinning), a mydriasis, a keratitis, a ptosis, a photophobia, formation of a back subkapsulyarny cataract, glaucoma, glaucoma with damage of an optic nerve.

At treatment by glucocorticoids the development of bacterial, fungal or virus (Herpes simplex) of an infection of eyes, a blepharitis or conjunctivitis connected with oppression of reaction of an organism to an infection is possible.

Interaction with other medicines:

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

Special researches of interaction of active agent of Pharmadeks with other medicines were not conducted.

There were messages on interaction of active agent after system use. However after Pharmadeks's instillation in an eye system absorption of dexamethasone so low that what risk - or interactions is minimum.

When using other local ophthalmologic drugs as the accompanying therapy, together with Pharmadeks it is necessary to adhere to an interval of 10-15 minutes between their use.

Contraindications:

Hypersensitivity to dexamethasone or to any of drug components;
viral diseases of a cornea and conjunctiva (the superficial keratitis caused by Herpes simplex, cow and chicken pox);
the mikobakterialny infections of an eye caused by Mycobacterium tuberculosis, Mycobacterium leprae or Mycobacterium avium;
fungus diseases of structures of an eye;
not treated form of a purulent infection of an eye.

Overdose:

There are no messages on any heavy system reactions in a consequence of overdose of drug.

In case of overdose at topical administration to wash out an eye (eye) warm water for removal of the remains of drug.

The specific antidote at topical administration of corticosteroids does not exist. Symptomatic treatment.

Use during pregnancy and feeding by a breast.

Safety of use of drug throughout the period of pregnancy and feeding is not established by a breast. At topical administration of eye drops of Pharmadeks system manifestation low therefore the risk is considered small, but the pregnant women and women nursing should estimate attentively a ratio advantage/risk at appointment.

Children.

Safety and efficiency of use of drug of Pharmadeks for treatment of children is not established therefore drug is not appointed to children.

Storage conditions:

To store in protected from light and the place, unavailable to children, at   a temperature from 15 °C to 25 °C. A period of validity — 3 years. After opening of a bottle drug is good 28 days.

Issue conditions:

According to the recipe

Packaging:

On 5 ml or 10 ml in the polyethylene bottle enclosed in a pack.