Active substanceDorzolamideDorzolamide
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  • Dosage form: & nbspeye drops
    Composition:

    Per 1 ml of the preparation:

    Active ingredient: dorzolamide hydrochloride in terms of dorzolamide 20.0 mg;

    auxiliary components: gheetylose 1.00 mg, mannitol 20.0 mg, citric acid monohydrate 4.00 mg, sodium hydroxide 2.4 mg, benzalkonium chloride 0.1 mg, water purified to 1.0 ml.

    Description:

    A clear, colorless solution.

    Pharmacotherapeutic group:antiglaucoma means - carbonic anhydrase inhibitor
    ATX: & nbsp

    S.01.E.C.03   Dorzolamide

    Pharmacodynamics:

    Antiglaucomatisant. Carbonic anhydrase inhibitor; reduces the secretion of intraocular fluid, slowing the formation of bicarbonate, followed by a weakening of the transfer Na+ and water. Does not cause a spasm of accommodation, miosis, gemeralopia.

    Pharmacokinetics:

    It penetrates the eye mainly through the cornea (to a lesser extent through the sclera or limbus). Systemic absorption is low. After entering the blood quickly penetrates into erythrocytes containing a significant amount of carbonic anhydrase II. The connection with plasma proteins is 33%.It is transformed into N-Desetylated metabolite, less active with respect to carbonic anhydrase II, but capable of blocking carbonic anhydrase I. With prolonged use, it accumulates in erythrocytes. It is excreted by the kidneys in the unmodified form and in the form of metabolites. After withdrawal, the rapid phase of withdrawal is replaced by a slow one, caused by the gradual release of the drug from erythrocytes, with a half-life (T1/2) about 4 months.

    Indications:Open angle (including secondary) glaucoma; pseudoexfoliation glaucoma; ophthalmohypertension.
    Contraindications:

    Hypersensitivity to any component, chronic renal failure (creatinine clearance less than 30 ml / min), hyperchloremic acidosis, children under 18 years of age, pregnancy, lactation period, oral intake of carbonic anhydrase inhibitors.

    Carefully:

    Diabetes mellitus, hepatic insufficiency, corneal diseases, use in patients after antiglaucomatous operations (risk of eye hypotension, retinal detachment).

    Dosing and Administration:

    Bury 1 drop in the affected eye 3 times a day; in combination with beta-blockers for topical administration - 1 drop 2 times a day.

    If several local ophthalmic medicines are used in the treatment, then their administration should occur at an interval of 10 minutes.

    Side effects:

    Local: burning, crawling, itchy eyes, watery eyes, blurred vision, irritation and swelling of the eyelids, conjunctivitis, superficial punctate keratitis, blepharitis, photophobia;

    rarely - Iridocyclitis, increased corneal thickness, allergic reactions; hypotension of the eye, retinal detachment in patients after antiglaucomatous operations.

    System: bitterness in the mouth, nausea, headache, fatigue, nefrourolitiaz, malignant erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), agranulocytosis, aplastic anemia, skin rashes.

    Overdose:

    Symptoms: disruption of water-electrolyte metabolism, acidosis, disorders of the central nervous system (CNS).

    Treatment: symptomatic. Controlling the level of electrolytes (especially K+) and blood pH.

    Interaction:

    Antiglaucoma drugs (beta-blockers, pilocarpine, dipyvephrine, carbachole) enhance the effect of dorzolamide.

    With simultaneous use with acetazolamide, the risk of systemic side effects increases.

    It is possible to increase toxicity when taking large doses of acetylsalicylic acid.

    Special instructions:

    Preservant contained in drops of dorzolamide (benzalkonium chloride), can be absorbed by soft contact lenses, inszsirritation of the eye and toxic effects. The drug is used only after removal of contact lenses. Wear contact lenses no earlier than 15 minutes after instillation.

    It is necessary to control the content of K+, electrolytes in serum and its pH.

    In the elderly, sensitivity to dorzolamide may increase (a dose reduction is required).

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

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Eye drops, 2%.

    Packaging:

    To 5 ml of solution in a white polymer bottle, equipped with a stopper-dropper and closed with a polymer cover with a safety ring.

    For 1 or 3 bottles together 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:

    2 years.

    After opening, the vial should not be stored for 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-006483/08
    Date of registration:13.08.2008 / 20.04.2015
    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: & nbsp20.01.2016
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