Allergoferon® beta (Allergoferon® beta)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBetamethasone + Interferon alfa-2bBetamethasone + Interferon alfa-2b
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  • Allergoferon® beta
    drops d / eye nazal. 
    FIRN M, ZAO     Russia
    • Dosage form: & nbspeye and nasal drops
    Composition:

    1 ml of the preparation contains:

    active substance: Betamethasone sodium phosphate 1.0 mg, interferon alfa-2b human recombinant not less than 5 000 IU;

    Excipients: Benzalkonium chloride 0.1 mg, disodium edetate dihydrate 0.5 mg, sodium chloride 3.2 mg, hypromellose 3 mg, potassium dihydrogen phosphate 3.63 mg, sodium hydrogen phosphate dodecahydrate 7.13 mg, povidone-8 thousand 5.0 mg, macrogol-4000 30.0 mg, macrogol-400 30.0 mg, water purified to 1.0 ml.

    Description:

    Transparent, colorless or with a yellowish tinge solution, with a slight specific odor.

    Pharmacotherapeutic group:Glucocorticosteroid for topical use + cytokine
    ATX: & nbsp

    S.01.B.A   Corticosteroids

    S.01.B.A.06   Betamethasone

    Pharmacodynamics:

    Allergoferon® beta is a combination drug whose pharmacological properties are due to the components that make up its composition. The drug has a pronounced local anti-inflammatory, anti-allergic, immunomodulatory effect. Has an antiexudative effect.

    Betamethasone sodium phosphate - Glucocorticosteroid (GCS), has a local anti-inflammatory, anti-allergic, anti-exsudative action.

    It inhibits the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and, accordingly, inhibition of the synthesis of metabolic products of arachidonic acid-cyclic endoperoxides, prostaglandins. It prevents the accumulation of neutrophils, which reduces inflammatory exudate and production of lymphokines, inhibits the migration of macrophages, leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of the chemotaxis substance (effect on the "late" allergy reaction), inhibits the development of an allergic reaction of immediate type (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).

    Interferon alfa-2b human recombinant - cytokine, has anti-inflammatory, immunomodulating, antiproliferative effect.

    Immunoregulatory properties of interferon allow you to change the immune response to the allergen by increasing the expression of the cells of the molecules of the main complex of histocompatibility and molecules Cd23 - low-affinity receptor for immunoglobulin (Ig) E (specific function of α-interferon) oppression Th2cells and amplification Th1cells, resulting in reduced synthesis IgE.

    Pharmacokinetics:

    When topical application of the drug systemic absorption - low. After instillation of the drug into the conjunctival sac betamethasone sodium phosphate penetrates well into the epithelium of the cornea and conjunctiva; while in the aqueous humor of the eye, therapeutic concentrations are achieved; When inflammation or damage to the mucosa, the penetration rate increases. The concentration achieved in plasma is so small that it can not be determined by modern analytical methods and has no clinical significance. The concentration of interferon alfa-2b, achieved in blood plasma, is well below the detection limit (the limit of determination of interferon alfa-2b - 1-2 IU / ml), which has no clinical significance.

    Indications:

    Seasonal allergic rhinitis and conjunctivitis (pollinosis) of the medium-severe course in the acute stage.

    Contraindications:

    - Hypersensitivity to interferon alpha-2b, betamethasone or other components of the drug;

    - viral (including herpetic), bacterial, fungal, mycobacterial infection;

    - trachoma;

    - glaucoma, cataract, diabetic retinopathy;

    - damage to the epithelium of the cornea (including the condition after removal of the foreign body);

    - ulcerous lesions of the nasal mucosa and nose trauma;

    - recent surgical interventions in the nasal cavity;

    - children's age till 18 years;

    - pregnancy;

    - the period of breastfeeding.

    Carefully:Arterial hypertension, severe hepatic insufficiency.
    Pregnancy and lactation:

    The use during pregnancy is contraindicated, as the data of clinical studies are not available.

    Women during lactation should refrain from breastfeeding during the use of the drug, because it is not known whether the components of the drug are allergenifer® beta in the composition of breast milk.

    Dosing and Administration:

    Conjunctival. For allergic conjunctivitis of moderate severity in the stage of exacerbation instillation in the conjunctival sac of each eye 1 drop 3 times a day, followed by a decrease in the number (the number of administrations per day), depending on the therapeutic effect.

    Intranasally. With an allergic rhinitis of moderate severity in the acute stage, 2 drops are injected into each nasal passage 3 times a day, with a gradual decrease in the number (the number of administrations per day), depending on the therapeutic effect. Duration of treatment is 10 days.

    Side effects:

    When using the drug Allergoferon® beta for 10 days, local and systemic adverse reactions were not detected.

    Possible adverse effects associated with exposure to GCS:

    - from the side of the organ of vision: increased intraocular pressure, glaucoma, optic nerve damage, decreased visual acuity and narrowing, cataract development, delayed wound healing, development of secondary eye infection, acute anterior uveitis, corneal and scleral perforation, mydriasis, accommodation disorder, ptosis, burning sensation, irritation eye, hyperemia of the conjunctiva;

    - from the ENT organs: ulceration and atrophy of the nasal mucosa, perforation of the nasal septum, rhinorrhea, sneezing, irritation of the mucous membrane of the nasal cavity, epistaxis, anosmia.

    Other: lacrimation, allergic reactions, headache.

    Overdose:

    With topical application of the drug, an overdose is unlikely. With prolonged use in high doses, as well as with the simultaneous administration of other glucocorticosteroids, symptoms of hypercorticism may appear. In this case, the use of the drug Allergoferon® beta should be discontinued.

    Interaction:

    With topical application, drug interactions are unlikely due to low systemic absorption of betamethasone.

    Perhaps a joint application with topical decongestants.

    Special instructions:

    During the use of the drug, it is necessary to monitor the intraocular pressure, the state of the cornea and the lens, since it is possible to develop a steroid glaucoma and cataracts.

    Allergoferon® beta contains a preservative benzalkonium chloride, which can be absorbed by soft contact lenses and cause a change in their color and have an adverse effect on the eye tissue (prolonged use may result in the development of acute keratitis and / or toxic corneal ulcer).

    If it is necessary to use contact lenses during treatment with the drug Allergoferon® beta, they should be removed before using the drug and, if necessary, dressed no earlier than 15 minutes after instillation.

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

    In view of possible lacrimation after instillation of the drug, within 30 minutes after instillation, it is necessary to refrain from potentially dangerous activities requiring increased attention, including driving.

    Form release / dosage:Eye and nasal drops.
    Packaging:

    For 5 and 10 ml in plastic bottles with a dispenser-dropper.

    1 bottle with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of 2 to 8 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years. The opened vial should not be stored for more than 30 days.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002999
    Date of registration:21.05.2015
    Expiration Date:21.05.2020
    The owner of the registration certificate:FIRN M, ZAO FIRN M, ZAO Russia
    Manufacturer: & nbsp
    FIRN M, ZAO Republic of Belarus
    Information update date: & nbsp10.07.2017
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