Allergodyl® (Allergodil®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAzelastineAzelastine
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  • Allergodyl®
    drops d / eye 
    Meda Pharma GmbH & Co. KG     Germany
  • Allergodyl®
    spray nazal. 
    Meda Pharma GmbH & Co. KG     Germany
  • Allergodil® C
    spray nazal. 
    Meda Pharma GmbH & Co. KG     Germany
    • Dosage form: & nbspeye drops
    Composition:

    1 bottle contains:

    Composition

    Volume of solution in vial

    6 ml

    10 ml

    Active substance: Azelastine hydrochloride

    3,000 mg

    5,000 mg

    Excipients:



    Hypromellose

    6,000 mg

    10,000 mg

    Disodium Edetate

    3,000mg

    5,000 mg

    Benzalkonium chloride

    0.750 mg

    1.250 mg

    Sorbitol

    399.996 mg

    666.660 mg

    Sodium hydroxide

    to pH 6.0

    to pH 6.0

    Water for injections

    Up to 6 ml (6.090 mg)

    Up to 10 ml (10.150 mg)
    Description:A colorless, clear or almost transparent solution.
    Pharmacotherapeutic group:Antiallergic - H1 histamine receptor blocker
    ATX: & nbsp

    R.01.A. C.03   Azelastine

    Pharmacodynamics:

    Azelastine, a derivative of phthalazinone, is strong antiallergic long-acting agent, selectively blocks H1-receptors. When applied to the eye mucosa, additional anti-inflammatory and membrane-stabilizing effects of azelastine are manifested: azelastine inhibits release mediators of the early and late phase of allergic reactions, for example, leukotriene, histamine, platelet activation factor; reduces the number of ICAM- 1 (intercellular adhesion molecule 1) and eosinophilic cells.

    Clinically significant effects on QT (QTc) the interval was not revealed even with prolonged use of high doses of azelastine.

    Pharmacokinetics:

    Even with repeated application of eye drops Allergoodil (1 drop in each eye four times a day), the maximum concentrations of azelastine in the plasma blood levels are very low and are detected at or below the measurement limit.

    Indications:

    -Profection and treatment of seasonal allergic conjunctivitis;

    - treatment of off-season (all-the-year-round) allergic conjunctivitis.

    Contraindications:
    • Hypersensitivity to the active substance or other components of the drug;
    • Age to 4 years;
    • I trimester of pregnancy.
    Pregnancy and lactation:In animal tests, an undesirable effect was observed on the fetus when the drug was administered orally at doses many times higher than the therapeutic dose, and therefore the use of the drug in the first trimester of pregnancy is not recommended, and in the II and III trimesters and lactation it is only possible in case of emergency, if the possible benefit for the mother exceeds the risk to the fetus / child.
    Dosing and Administration:

    Seasonal allergic conjunctivitis: in the absence of other recommendations of the doctor-adults and children from 4 years instilled 2 times a day (morning and evening) 1 drop in each eye. If necessary, increase the dose to 4 times a day, one drop in each eye! The drug is used until the symptoms disappear, but not more than 6 weeks.

    In the case of an alleged allergen exposure, the drug is used for prophylactic purposes.

    Non-seasonal (all-the-year-round) allergic conjunctivitis: in the absence of other recommendations of the doctor adults and children from 4 years bury 2 times a day (morning and evening) 1 drop in each eye. If necessary, increase the dose to 4 times a day, one drop in each eye.

    Duration of application - no more than 6 weeks.

    Side effects:

    The incidence of side effects is defined as follows:

    Very often:> 1/10;

    Often: <1/10> 1/100;

    Infrequently: <1/100> 1/1000;

    Rarely: <1/1000> 1/10000;

    Very rarely: <1/10000.

    Local:

    often - transient fogging of vision, conjunctivitis; rarely a burning sensation in the eye.

    Are common:

    infrequently - a feeling of bitterness in the mouth;

    very rarely - allergic reactions, headache, asthma, dyspnoea, fatigue, flu-like symptoms, pharyngitis, itching, rhinitis.

    Overdose:

    Data on drug overdose are absent.

    Interaction:Not found. In case of concomitant therapy with other eye drops, they should be instilled in the eyes with an interval of at least 15 minutes.
    Special instructions:

    When using eye drops, contact lenses should not be worn.

    Effect on the ability to drive transp. cf. and fur:In the case of blurred vision immediately after instillation of the drug, you should refrain from driving and doing activities, requiring increased attention, before its restoration.
    Form release / dosage:

    Eye drops 0.05%.

    Packaging:

    6 ml or 10 ml of solution in a bottle of translucent high-density polyethylene with a low-density polyethylene dropper with a white cap made of high-density polyethylene.

    1 bottle together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    After opening the bottle the drug should be used within 4 weeks.

    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N012735 / 01
    Date of registration:23.09.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Meda Pharma GmbH & Co. KGMeda Pharma GmbH & Co. KG Germany
    Manufacturer: & nbsp
    Representation: & nbspMEDA PHARMA LLCMEDA PHARMA LLC
    Information update date: & nbsp08.07.2017
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