Deksametazon-Darnitsa drops
Producer: CJSC Pharmaceutical Firm Darnitsa Ukraine
Code of automatic telephone exchange: S01BA01
Release form: Liquid dosage forms. Drops.
General characteristics. Structure:
Active ingredient: dexamethasone;
1 ml of solution contains 1 mg of dexamethasone of sodium of phosphate (in terms of 100% substance, anhydrous, free from ethanol);
excipients: boric acid, sodium pyroborate, dinatrium эдетат, a benzalkoniya chloride, water for injections.
Pharmacological properties:
Pharmacodynamics. The synthetic fluorinated glucocorticoid with the expressed antiinflammatory, antiallergic, immunosuppressive action. When drawing on a conjunctiva of an eye suppresses the reaction of an inflammation caused by influence of mechanical, chemical factors or allergens. The mechanism of effect of drug is similar to pharmacological action of other fluorinated glucocorticoids and differs only in the bigger force and duration of effect. Dexamethasone reduces permeability of a vascular wall, slows down formation of fibrin, migration of leukocytes and phagocytes in the inflammation center, has immunosuppressive effect, oppresses proliferation of fibroblasts and formation of collagen. At topical administration can reduce outflow of liquid and lead to increase in intraocular pressure, promoting an aggravation of an open angle glaucoma.
Pharmacokinetics. After an instillation in a conjunctival sac in therapeutic doses the systemic resorptive effect of dexamethasone is insignificant. Dexamethasone gets through a cornea into moisture of an anterior chamber. At an inflammation of tissues of eye or injury of a mucous membrane and a cornea intensity of absorption of drug increases.
Pharmaceutical characteristics:
main physical and chemical properties: inodorous transparent colourless liquid.
Indications to use:
– Acute and chronic not purulent inflammatory and allergic diseases of eyes: conjunctivitis, a keratoconjunctivitis, a uveitis, a keratitis without damage of an epithelium, an iritis, an iridocyclitis, an episcleritis, a sclerite;
– prevention of formation of cicatricial fabric after injuries of an eye or operative measures, thermal or corrosive burns of eyes.
Route of administration and doses:
The bottle is protected by opening control. At the first use it is necessary to turn a cap, having separated it from a protective ring.
The bottle has a special configuration thanks to which with a pressure upon a bottom there is a dosed release of solution by the principle "one pressing – one drop". Rigidity of walls of a bottle considerably reduces a possibility of jet release of drug – the frequent reason of overdose of eye drops.
The adult dig in in a conjunctival sac of the affected eye by easy pressing bottle walls on 1-2 drop 3-4 times a day. At acute inflammatory and allergic states dig in on 1-2 drop each 1-2 hours, after reduction of symptoms of an acute inflammation – on 1-2 drop each 4-6 hours. The course of treatment, as a rule, makes 7-10 days.
After injuries or operations, since 8 in the afternoon after operation or from the moment of an injury, dig in on 1-2 drop 2-4 times a day within 7-10 days. After the protivoglaukomny filtering operation drug is used in day of operation or next day after it.
Features of use:
Side effects which are noted at drug use disappear in 5-15 seconds and are not the indication for its cancellation. Drug is intended only for topical administration.
Prolonged use of drug which considerably exceeds recommended can lead to emergence of the consecutive infection caused by mushrooms or viruses emergence or acceleration of development of a cataract, increase in intraocular pressure in the patients predisposed to it is possible, development of glaucoma is in exceptional cases possible.
During use of drug it is necessary to check a condition of a cornea (to carry out fluorescence tests), to control intraocular pressure.
At use of drug it is not necessary to touch a dropper tip to prevent drug pollution.
Before drug use soft contact lenses it is necessary to remove and insert them again not earlier, than in 15 minutes from the drug instillation moment.
Extra care is necessary at use of drug after a herpes simplex. In such cases drug is recommended to be used under strict medical observation.
For the prevention of a possible system resorption after an instillation of drug it is necessary to keep fingers the lacrimal canals for 2-3 minutes.
Ability to influence speed of response at control of motor transport or in operating time with other difficult mechanisms. As well as in case of use of other eye drops, the temporary zatumanennost of sight or other vision disorders can influence speed of response at control of motor transport or in operating time with other difficult mechanisms. If during an instillation there is a sight zatumanennost, the patient needs to wait until sight is recovered, and already then to manage motor transport or to work with mechanisms.
Side effects:
From system of sense bodys: from organs of sight - right after an instillation perhaps short-term burning sensation, discomfort in an eye, burning, a pricking, a hyperemia and lachrymation. At prolonged use: 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 and glaucoma. At treatment by glucocorticosteroids development of bacterial, fungal or viral (Herpes sіmplex) infections of an eye is possible.
Allergic reactions: reactions of hypersensitivity of the slowed-down type. Patients with hypersensitivity to a benzalkoniya of chloride can have an allergic blepharitis or conjunctivitis.
Interaction with other medicines:
At topical administration of dexamethasone interaction with other remedies is noted.
In case of the accompanying therapy with use of other local ophthalmologic drugs it is necessary to adhere to an interval of 10-15 minutes between their use.
Contraindications:
Hypersensitivity to dexamethasone and to other glucocorticosteroids or to any other components of drug;
treelike herpetic keratitis and other viral diseases of eyes;
bacterial and/or fungus infectious diseases without the corresponding therapy by antibiotics;
damage and ulcer processes on a cornea;
open or closed-angle glaucoma;
the oppression of immune functions caused by diseases or drug treatment.
Use during pregnancy or feeding by a breast. Purpose of dexamethasone during pregnancy is possible if the expected effect of therapy exceeds potential risk for a fruit. In need of use in the period of a lactation feeding by a breast needs to be stopped.
Children. Drug is not used to children.
Overdose:
The special configuration of a bottle does improbable accidental overdose of drug. Overdose possible only at non-compliance with the single doses specified in the instruction and frequencies of use.
Eye drops of Deksametazon-Darnitsa have no essential systemic action.
The overdose can strengthen local side reactions.
Treatment: symptomatic therapy.
Storage conditions:
Period of validity 2 years. After opening of a bottle drug is stored by 28 days. To store in the place, unavailable to children, in original packaging at a temperature not above 15 °C.
Issue conditions:
According to the recipe
Packaging:
On 5 ml or 10 ml at the bottles from polymeric material closed by covers droppers with opening control. On 1 bottle in a pack.