Active substanceDorzolamideDorzolamide
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  • Glaucopt
    drops d / eye 
    Rowecq Limited     United Kingdom
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  • Dorzopt
    drops d / eye 
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  • Dosage form: & nbspeye drops
    Composition:

    In 1 ml contains:

    Active substance: dorzolamide hydrochloride 22.3 mg (in terms of dorsolamide 20.0 mg)

    Excipients: benzalkonium chloride 0.1 mg, citric acid anhydrous 18.3 mg, mannitol 20.0 mg, hypromellose 1.0 mg, hydrochloric acid q. s. before adjustment pH, sodium hydroxide q. s. until the pH is adjusted, water for injection up to 1.0 ml.

    Description:A clear, colorless solution.
    Pharmacotherapeutic group:The antiglaucoma agent is a carbonic anhydrase inhibitor
    ATX: & nbsp

    S.01.E.C.03   Dorzolamide

    Pharmacodynamics:

    The composition of Glaucopt includes an inhibitor of carbonic anhydrase II - dorzolamide hydrochloride. Inhibition of carbonic anhydrase (CA) in the ciliary body of the eyeball reduces the production of intraocular fluid, presumably due to a slowing down of the synthesis of bicarbonate ions with their subsequent reduction to sodium and elimination of the liquid. As a result, the intraocular pressure (IOP) decreases.

    Pharmacokinetics:

    With prolonged use dorzolamide selectively accumulates in erythrocytes as a result of selective binding with carbonic anhydrase-II (KA-II), while the concentration of free dorzolamide in plasma remains extremely low. Dorzolamide forms a single metabolite - N-residyl-dorzolamide, suppressing to a lesser degree than dorzolamide, the enzyme KA-II, as well as the enzyme KA-I. Metabolite accumulates in the erythrocytes, mainly in contact with KA-I. Dorzolamide in a moderate degree binds to plasma proteins (about 33%). Dorzolamide and its metabolite are excreted mainly unchanged through the kidneys. After the end of treatment dorzolamide it is washed out from erythrocytes unevenly, i.e. very intensively at the beginning, which leads to a rapid and significant decrease in concentration, followed by a phase of slow elution with a half-life of about 4 months.

    Indications:

    Glaucopt is prescribed for adults with:

    - ophthalmohypertension;

    - primary open-angle glaucoma;

    - pseudoexfoliation glaucoma;

    - secondary glaucoma (without the angle block of the anterior chamber of the eye);

    The drug is administered to children:

    - for the treatment of glaucoma in children from 1 week in monotherapy or as a supplement to the treatment with beta-blockers.

    Contraindications:

    - Age is less than 1 week;

    - hypersensitivity to the components of the drug;

    - chronic renal failure;

    - pregnancy;

    - the period of lactation.

    Carefully:

    The drug has not been studied in patients with severe hepatic impairment, and therefore should be used with caution in this patient category.

    Dosing and Administration:

    When using the drug, the usual dosage is 1 drop in the affected eye (or both eyes) in the morning, in the afternoon and in the evening.

    When replacing any antiglaucoma drug with Glaucopt, Glaucot should be started on the day following the withdrawal of the previous drug.

    When Glaucotte is used simultaneously with other eye drops, they should be instilled with an interval of at least 10 minutes.

    Side effects:

    Undesired reactions recorded during the research and during the post-registration period are classified by frequency (very frequent (> 1/10), frequent (≥1 / 100, <1/10), infrequent (≥1 / 1000, <1/100 ), rare (≥1 / 10000, <1/1000).

    From the nervous system

    Often: headache.

    Rarely: dizziness, paresthesia.

    From the side of the organ of vision

    Very often: burning and pain.

    Often: superficial punctate keratitis, lacrimation, conjunctivitis, inflammation of the eyelids, itching, eyelid irritation, blurred vision.

    Infrequently: iridocyclitis.

    Rarely: reddening of the eyes, pain, hyperkeratosis of the eyelids, transient myopia (disappearing after drug discontinuation), corneal edema, decreased intraocular pressure, detachment of the choroidal coat of the eyes after surgical interventions to restore outflow of intraocular fluid.

    On the part of the respiratory system, thorax and mediastinum

    Rarely: nosebleeds.

    From the gastrointestinal tract

    Often: nausea, bitter taste in the mouth.

    Rarely: pharyngitis, dry mouth.

    From the skin and mucous membranes

    Rarely: contact dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis.

    From the side of the urinary tract

    Rarely: urolithiasis.

    General disorders and disorders at the site of administration

    Often: asthenia, fatigue.

    Rarely: allergic reactions - signs and symptoms of local reactions (eyelid) and systemic allergic reactions, including angioedema, urticaria, pruritus, rash, difficulty breathing, less often - bronchospasm.

    Children

    In children younger than 6 years, the profile of adverse reactions of dorzolamide is comparable to the profile of adverse reactions in adult patients. The most frequent adverse reactions associated with the use of dorsolamide in children younger than 2 years of age were conjunctival injection (5.4%) and discharge from the eyes (3.6%). In children from 2 to 6 years, the most frequent adverse reactions were a burning sensation in the eye (12.1%), conjunctival injection (7.6%), eye pain (3%), inflammation of the eyelids (3%).

    Overdose:

    Possible electrolyte disorders, the development of metabolic acidosis and the emergence of drowsiness, nausea, dizziness, headache, weakness, unusual dreams, dysphagia. Plasma concentrations of electrolytes (especially potassium) and blood pH values ​​should be monitored.

    In case of an overdose, symptomatic therapy is carried out, aimed at maintaining the vital functions of the body.

    Interaction:

    Special studies to study the interaction of the drug Glaucot with other drugs ns was carried out. In clinical trials of the drug, Glaucopt was administered in combination with other medications without negative effects of inter-drug interaction, including: with eye drops of timolol and betaxolol,as well as systemic drugs: ACE inhibitors, blockers calcium channels, diuretics, non-steroidal anti-inflammatory drugs (including acetylsalicylic acid), hormones (estrogen, insulin, thyroxine).

    The possibility of mutual reinforcement of the systemic effects of carbonic anhydrase inhibitors for internal use and the Glaucopt preparation during their simultaneous use is not ruled out. Combined treatment with drugs that have systemic effects and local inhibitors of carbonic anhydrase (Glaucopt) in clinical studies has not been studied.

    Glaucopt is an inhibitor of carbonic anhydrase, and although applied topically, it is partially absorbed and can have a systemic effect. In clinical trials, the use of the drug was not accompanied by a violation of the acid-alkaline balance. However, similar phenomena were observed with the use of inhibitors of carbonic anhydrase, including as a result of inter-drug interaction with other drugs (as a manifestation of toxicity against the background of high doses of salicylates).

    Thus, when prescribing Glaucopt, one should not forget about the possibility of such inter-drug interactions.

    The patient should inform the doctor about all medications that he uses or plans to use, including those that are sold without a prescription. It should pay special attention to the reception of high doses of acetylsalicylic acid.

    Special instructions:

    Use in patients using contact lenses:

    Patients who wear contact lenses should consult a doctor before using the drug, since the preservative included in the product may cause eye irritation.

    The preparation Glaucopt contains as a preservative benzalkonium chloride, which can be adsorbed by contact lenses. Before using the drug, the lens must be removed; Do not wear the lens before 15 minutes after instillation. Benzalkonium chloride It is able to discolor soft eye lenses.

    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 with Glaucopt, it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Eye drops, 2%.

    Packaging:

    5 ml of the drug in a bottle of low-density polyethylene with a stopper and a screw cap, which is equipped from the inside with a pointed rod for puncturing the plug-dropper.

    One bottle together with the instruction for use is placed in a cardboard box.
    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C. Do not freeze. Keep out of the reach of children.

    Shelf life:

    2 years.

    Use within 1 month after opening the vial.

    The drug should not be used after the expiry date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004438
    Date of registration:01.09.2017
    Expiration Date:01.09.2022
    The owner of the registration certificate:Rowecq LimitedRowecq Limited United Kingdom
    Manufacturer: & nbsp
    Information update date: & nbsp04.10.2017
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