Medeksol 5 ml of 0.1% eyedrops

The instruction for medical use of MEDEKSOL medicine the Trade name Medeksol Mezhdunarodnoye the unlicensed name Dexamethasone Dosage Form of the Drop eye 0.1% 5 ml Structure of 1 ml of drug contains active agent – phosphate sodium dexamethasone (it is equivalent phosphate dexamethasone) 1 mg, excipients: creatinine, sodium citrate, sodium borate, polysorbate 80, a benzalkoniya chloride, dinatrium edetat, 5M acid chlorohydrogen, sodium metabisulphite, water for injections the Description Transparent liquid, colourless or poorly yellow color, flavourless. Pharmacotherapeutic group Drugs for treatment of diseases of eyes. Anti-inflammatory drugs. Glucocorticosteroids. Dexamethasone ATX S01BA01 Code Pharmacological Pharmacokinetics At properties topical administration system absorption low. After instillation in an eye well gets through an epithelium of a cornea and a conjunctiva, at the same time in the watery environment of an eye therapeutic concentration are reached. At inflammation or damage mucous the speed of a penetration increases. A small amount of dexamethasone comes to a system blood stream. Dexamethasone contacts proteins of plasma for 60-70%. It is metabolized in a liver under the influence of cytochromium enzymes, metabolites are removed through intestines. Elimination half-life averages 3 hours. A pharmacodynamics the Synthetic fluorinated glucocorticoid drug for topical administration. Has anti-inflammatory, antiallergic and anti-exudative effect. Interacting with a specific proteinaceous receptor in target tissues, regulates an expression of kortikoid-dependent genes and influences thus protein synthesis. Release by eosinophils of mediators of inflammation oppresses, induces formation of lipokortin and reduction of quantity of the mast cells producing hyaluronic acid, reduces permeability of capillaries. Stabilizes lizosomalny enzymes of membranes of leukocytes, slows down synthesis of kinin, a mitosis and migration of leukocytes, inhibits synthesis of antibodies and breaks antigen recognition. Reduces quantity of the circulating basophiles that leads to decrease in discharge of mediators of an immediate allergy, reduces influence of mediators of an allergy to effector cells. All these effects participate in suppression of inflammatory reaction in fabrics in response to mechanical, chemical or immune destruction. Duration of anti-inflammatory action after burying 1 drop of drug is from 4 to 8 hours. Indications - acute and chronic inflammatory processes not purulent forms of conjunctivitis, keratitis, keratoconjunctivitis and blepharitis, a sclerite and an episcleritis, an iritis, an iridocyclitis and other uveites of various genesis, a non-infectious dermatosis of a century, a sympathetic ophthalmia - superficial injuries of a cornea of various etiology (chemical, physical or immune) after a full epitalization of a cornea - allergic diseases of eyes: allergic conjunctivitis or a keratoconjunctivitis - prevention and treatment of the inflammatory phenomena in the postoperative and posttraumatic period. The route of administration and doses to Adults and children are more senior than 12 years at acute inflammatory processes Medeksol dig in in a conjunctival sac 1-2 drops of 4-5 times a day within 2 days, then apply 3-4 times a day within 4-6 days. If the desirable effect did not come within 3-4 days perhaps use of additional system therapy. At chronic processes, drug is dug in by 2 times a day within 4 weeks. The maximum duration of use of drug – 2-3 weeks. In the postoperative and posttraumatic periods depending on degree of intensity of inflammatory process Medeksol dig in 2-4 times a day on 1-2 drops within 2-4 weeks. To children aged from 6 up to 12 years at treatment of allergic and inflammatory processes dig in on 1 drop 2-3 times a day within 7-10 days. In case of need treatment is continued after carrying out for the 10th day of flyuorestseinovy test (for check of integrity of a corneal epithelium). Side effects Local reactions: directly after burying drug perhaps quickly passing burning sensation, dacryagogue, misting of sight, a mydriasis, corneal gripes, eye pain - is possible increase in intraocular pressure, development of glaucoma with damage of an optic nerve, decrease in visual acuity and loss of fields of vision and also forming of a back subkapsulyarny cataract, thinning and perforation of a cornea is also possible - use of hormonal drugs can slow down healing of wounds Very seldom - a ptosis a century - spread of a herpes and bacterial infection - development of consecutive infection, a fungal infection of a cornea at prolonged use of steroids At patients with hypersensitivity to dexamethasone or the benzalkoniya to chloride can develop allergic conjunctivitis and blepharitis - an itching, a palpebralny erythema or a conjunctival erythema At prolonged use the increase in risk of development of the system side effects characteristic of glucocorticosteroids is possible: - decrease in tolerance to glucose, steroid diabetes or a demonstration of latent diabetes, oppression of function of adrenal glands, an Icenco-Cushing syndrome - nausea, vomiting, increase or a loss of appetite, exacerbation of chronic diseases of digestive tract - arrhythmias, bradycardia, increase in arterial blood pressure - increase in intracranial pressure, nervousness or concern, insomnia, dizziness, a headache. Contraindications - hypersensitivity to any of drug components - a keratitis, the caused herpes simplex, chicken pox and other viral diseases - mikobakterialny infections of eyes - fungus diseases of eyes - acute purulent diseases of eyes with injury of a corneal epithelium - a cornea epiteliopatiya - the increased intraocular pressure - trachoma - children's age up to 12 years - tuberculosis of eyes Medicinal interactions Medeksol due to induction of microsomal enzymes of a liver shortens elimination half-life of Phenytoinum, barbiturates, digitoxin, levomycetinum, erythromycin, blockers of calcium channels, quinidine and warfarin. At the same time barbiturates, fenotoin, inducing activity of microsomal enzymes too, accelerate Medeksol's elimination. At the usual mode of topical administration the dose is insufficient to cause induction or saturation of liver enzymes. The special instructions Drug are not recommended to be used when carrying contact lenses. Before use of drug it is necessary to remove contact lenses and to put on them not earlier than in 15 minutes. If drug is used within 2 weeks and more, it is necessary to measure intraocular pressure regularly. When assigning the patients with herpes of a cornea should mean a possibility of its perforation. Drug treatment can mask a picture of a bacterial or fungal infection therefore at treatment of infectious diseases of eyes and ears drug should be combined with adequate antimicrobial therapy. Pregnancy and the period of a lactation Clinical data on use during pregnancy and in the period of a lactation are absent and Medeksol's use is possible only on doctor's orders when the expected advantage for mother exceeds potential risk for a fruit or the baby. It is necessary to stop breastfeeding for the period of drug use. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms B to a type of possible dacryagogue, indistinct sight after burying drug is not recommended to apply it just before control of vehicles and service of the mechanical equipment. The overdose At topical administration of drug overdose is improbable. At overdose strengthening of side effects as locally, and system character is possible. It is necessary to carry out symptomatic therapy. The form of release and packing On 5 ml of drug place in a plastic bottle with a stopper dropper and the screwing-up protective cap supplied with a safety ring. On 1 bottle together with the instruction for medical use in the state and Russian languages put in a cardboard box. To Store storage conditions at a temperature not above 25 °C. To store out of children's reach! The use period after opening of a bottle within 1 month. 2 years not to apply an expiration date after an expiration date. Prescription status According to the prescription the Owner of a trademark and the registration certificate is the UORLD of OFTALMIKS MEDICINE company, Great Britain Producer E.I.P.I. To., Egypt, Tens ov City Ramadan, the First B1 Industrial Zone, p.o. box 149 Tens ("E.I.P.I.CO." Egypt, Tenth of Ramadan City, First Industrial Area B1, P.O. box: 149 Tenth)
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