Active substanceDexamethasoneDexamethasone
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  • Dosage form: & nbspeye drops
    Composition:

    To 1.0 ml of the preparation:

    Active ingredient: dexamethasone 1.0 mg;

    auxiliary components: polysorbate 80, hypromellose (hydroxypropylmethylcellulose 4000), disodium phosphate dodecahydrate, citric acid monohydrate, sodium chloride, disodium edetate dihydrate, benzalkonium chloride, purified water.

    Description:

    A suspension of white color, possibly the presence of a precipitate, which dissipates rapidly with mild agitation.

    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    H.02.A.B.02   Dexamethasone

    S.01.B.A.01   Dexamethasone

    H.02.A.B   Glucocorticoids

    S.01.B.A   Corticosteroids

    Pharmacodynamics:

    Glucocorticoid drug for topical application in ophthalmology. Has a pronounced anti-inflammatory, anti-allergic and anti-exsudative action.

    Interacting with a specific protein receptor in target tissues, regulates the expression of corticoid-dependent genes and thus affects protein synthesis. Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, prostaglandins, lysosomal enzymes).Suppresses the migration of cells to the site of inflammation; reduces vasodilation and increased vascular permeability in the focus of inflammation. Stabilizes lysosomal enzymes of leukocyte membranes; Suppresses the synthesis of antibodies and disrupts the recognition of the antigen. It inhibits the release of interleukin-1 and interleukin-2, interferon-gamma from lymphocytes and macrophages. It induces the formation of lipocortin, inhibits the release of eosinophils by inflammatory mediators and stabilizes the membranes of mast cells. All these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical or immune damage.

    The duration of anti-inflammatory action after instillation of 1 drop of solution is from 4 to 8 hours.

    Pharmacokinetics:

    After pricking into the conjunctival sac it penetrates well into the corneal epithelium and conjunctiva; while in the aqueous humor of the eye, therapeutic concentrations are achieved; with inflammation or damage to the mucous membrane, the penetration rate increases. About 60-70% of dexamethasone entering the systemic circulation communicates with plasma proteins.Metabolised in the liver by the action of cytochrome-containing enzymes; metabolites are excreted through the intestine. The half-life (T1/2) is an average of 3 hours.

    Systemic absorption of the drug is minimal.

    Indications:

    Conjunctivitis (non-inflammatory and allergic), keratitis, keratoconjunctivitis (without epithelial damage), blepharitis, scleritis, episcleritis, chorioretinitis, uveitis, blepharoconjunctivitis, optic neuritis, prevention and treatment of inflammation after surgery and trauma, sympathetic ophthalmia, corneal transparency and reduction neovascularization after keratitis, burns.

    Contraindications:

    Hypersensitivity, viral and fungal eye diseases, purulent eye diseases (without concomitant antimicrobial therapy), trachoma, increased intraocular pressure, damage to the integrity of the corneal epithelium; tuberculosis of the eye; children's age till 6 years; pregnancy; lactation.

    Dosing and Administration:

    Locally.

    In acute inflammatory processes the drug is punctured into the conjunctival sac by 1-2 drops 4-5 times a day for 2 days; In the future, the drug is used 1-2 drops 3-4 times a day for 4-6 days.

    In chronic inflammatory processes the drug is digested 2 times a day for 3-6 weeks. The maximum duration of the drug is 6 weeks.

    For allergic diseases the eye is buried in the conjunctival sac for 1-2 drops 4-5 times a day for 2 days with a gradual withdrawal within 1-2 weeks.

    If the eyeball is damaged as a result of injuries or during surgical interventions after an antiglaucoma filtering operation, the drug is used on the day of the operation or the next day.

    After the operation of cataract extraction, surgery for strabismus, retinal detachment, and also after trauma the drug is used starting from the 8th day. Depending on the degree of symptoms of inflammation, the drug should be instilled in 1-2 drops 2-4 times / day for 2-4 weeks.

    Children aged 6 to 12 years In the treatment of allergic and inflammatory conditions, one drop is dripped 2-3 times / day for 7-10 days. If necessary, the treatment is continued after a fluorescein test (for checking the integrity of the corneal epithelium) on the 10th day.

    Side effects:

    Basically, the drug has good tolerability

    Local reactions: immediately after instillation of the drug, a rapid burning sensation, lacrimation, blurring of vision is possible.

    With prolonged use (more than 2 weeks), an increase in intraocular pressure is possible; the development of glaucoma with optic nerve damage, reduced visual acuity and loss of visual fields, as well as the formation of posterior subcapsular cataract, and also the thinning and perforation of the cornea; very rarely - the spread of herpetic and bacterial infection.

    In patients with hypersensitivity to dexamethasone or benzalkonium, chloride may develop allergic conjunctivitis and blepharitis.

    Itching, palpebral erythema, or conjunctival erythema.

    In the case of corneal or scleral ulcers, a corticosteroid may delay healing and promote re-infection.

    With prolonged use, an increased risk of developing system side effects of glucocorticosteroids:

    From the endocrine system: reduction of glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, oppression of adrenal function, Itenko-Cushing syndrome.

    From the digestive system: nausea, vomiting, increased or decreased appetite, exacerbation of chronic diseases of the gastrointestinal tract.

    From the cardiovascular system: arrhythmias, bradycardia, increased blood pressure.

    From the nervous system: increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, headache.

    Overdose:

    Overdose when used in ophthalmology is unlikely.

    Symptoms: local manifestations are possible. There is no specific antidote. The drug should be withdrawn and symptomatic therapy prescribed.

    Prolonged or use in large doses of a suspension may increase the systemic absorption of the drug, and possibly the appearance of ocular hypertension in some patients and the appearance of certain diseases of the cornea or lens.

    Interaction:

    With prolonged use with idoxuridine, it is possible to intensify destructive processes in the corneal epithelium.

    Dexamethasone can enhance the action of barbiturates.

    The combined use of phenytoin with dexamethasone leads to a decrease in the concentration of the latter.

    Warfarin combined with dexamethasone increases the risk of bleeding.

    In normal local administration, the dose is not sufficient to induce the induction or saturation of liver enzymes.

    Joint application:

    - with diuretics (especially "thiazide" and inhibitors of carbonic anhydrase) and amphotericin B can lead to increased excretion of potassium (K +) and an increased risk of developing heart failure;

    - from cardiac glycosides - their tolerance is worsened and the likelihood of developing ventricular extrasystole (due to induced hypokalemia) increases;

    - with ethanol and non-steroidal anti-inflammatory drugs (NSAIDs) - the risk of erosive and ulcerative lesions in the gastrointestinal tract increases.

    Estrogens and oral estrogen-containing contraceptives reduce the clearance of dexamethasone, which may be accompanied by an increase in the severity of its action.

    The combined use of antiarrhythmic drugs with dexamethasone may lead to a decrease in the effect of the latter.

    Special instructions:

    Before use, the preparation should be shaken.

    The drug is intended only for topical application to the conjunctival sac. Do not use for intraocular injection.

    If there is no improvement after 3-4 days of treatment, additional local or systemic therapy is prescribed.

    The composition of the drug is benzalkonium chloride, an antimicrobial preservative that can be absorbed by soft contact lenses. Therefore, you should not use the drug while wearing contact lenses (soft). It is necessary to remove the lenses before using the drug and their wearing is possible only 15 minutes after instillation.

    When using the drug in combination with other ophthalmic drops, the interval between instillations should be kept at least 15 minutes.

    Treatment with the drug can mask the picture of a bacterial or fungal infection, so when treating infectious eye diseases the drug should be combined with adequate antimicrobial therapy.

    Dexamethasone can lead to a false positive test result for doping.

    Effect on the ability to drive transp. cf. and fur:

    Taking into account the possibility of lacrimation after instillation of the drug, do not apply it directly before driving vehicles or working with mechanisms.

    Within 30 minutes after instillation, it is necessary to refrain from occupations requiring increased attention.

    Form release / dosage:

    Eye drops, 0,1%.

    Packaging:

    For 10 ml of the drug in a white polymer bottle-dropper closed with a polymer lid with a safety ring.

    One bottle-dropper along with instructions for use in a cardboard pack.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    In a place inaccessible to children.

    Shelf life:

    3 years. After opening the vial, store it for no more than 4 weeks.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001806/08
    Date of registration:17.03.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania
    Manufacturer: & nbsp
    Representation: & nbspРомфарма ОООРомфарма ООО
    Information update date: & nbsp21.03.2017
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