Vibrocil® (Vibrocil®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDimethinden + PhenylephrineDimethinden + Phenylephrine
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  • Vibrocil®
    gel nazal. 
    GlaxoSmithKline Helsker, ZAO     Russia
  • Vibrocil®
    drops nazal. 
    GlaxoSmithKline Helsker, ZAO     Russia
  • Vibrocil®
    spray nazal. 
    GlaxoSmithKline Helsker, ZAO     Russia
    • Dosage form: & nbspgel nasal
    Composition:

    Active substances: phenylephrine 2.5 mg, dimethindene maleate 0.25 mg.

    Excipients: sodium hydrophosphate anhydrous 4.4 mg, citric acid monohydrate 2.6 mg, sorbitol 35 mg, benzalkonium chloride solution 50% (in terms of dry matter) 0.2 mg (0.1 mg), lavender oil 0.2 mg, hypromellose 20 mg, purified water 935 mg.

    Description:Homogeneous gel from colorless to slightly yellow with a weak specific smell of lavender, free from foreign mechanical particles.
    Pharmacotherapeutic group:Antitussive medication
    ATX: & nbsp

    A.01.B.A.53   Phenylephrine in combination with other drugs

    Pharmacodynamics:

    Vibrocil® is a combined preparation containing phenylephrine and dimethindene. Phenylephrine - sympathomimetic agent, with local application has a moderate vasoconstrictive effect (due to the stimulation of alpha1-adrenergic receptors located in the venous vessels of the nasal mucosa), eliminates the edema of the nasal mucosa and its adnexal sinuses.

    Dimethinden is an antiallergic agent, an antagonist of histamine H1 receptors; does not reduce the activity of the ciliated epithelium of the nasal mucosa.
    Pharmacokinetics:

    Vibrocil® is for topical use, and its activity does not depend on the concentration of active substances in the blood plasma.

    Indications:Acute rhinitis (including, runny nose with colds); allergic rhinitis (including hay fever); vasomotor rhinitis; chronic rhinitis; acute and chronic sinusitis; acute otitis media (as an auxiliary method of treatment). Preparation for surgical interventions in the nose area and elimination of swelling of the nasal mucosa and accessory sinuses after surgical interventions in this area.
    Contraindications:Hypersensitivity to phenylephrine, dimethindene maleate or other components of the drug. Atrophic rhinitis (including, with fetid detachable - ozena). Acceptance of MAO inhibitors (simultaneously or in the previous 14 days). Closed-angle glaucoma. Children under 6 years.
    Carefully:Cardiovascular diseases (arterial hypertension, arrhythmias, generalized atherosclerosis), hyperthyroidism,adenoma of the prostate gland, diabetes mellitus, obstruction of the bladder neck (for example, due to prostatic hypertrophy), epilepsy.

    As with any local vasoconstrictor, care should be taken when prescribing Vibrocil® to patients with severe reactions to sympathomimetics, manifested as insomnia, dizziness, tremor, cardiac arrhythmia, or high blood pressure.

    Pregnancy and lactation:

    Given the possible systemic vasoconstrictive effect of phenylephrine, Vibrocil® is not recommended for use during pregnancy and lactation.

    Dosing and Administration:

    Children under the age of 6 years: contraindicated.

    Children aged 6 to 12 years (under the supervision of adults), the gel is applied to each nasal passage as deep as possible 3-4 times a day.

    Teenagers over the age of 12 and adults are given a gel in each nasal passage as deep as possible 3-4 times a day. The last application is carried out shortly before sleep. The use of the drug immediately before bedtime provides an effect throughout the night.

    The drug should not be used continuously for more than 7 days.If symptoms persist, consult a physician.

    Side effects:

    Classification of incidence of adverse events (WHO):

    very often> 1/10; often from> 1/100 to <1/10; infrequently from> 1/1000 to <1/100; rarely from> 1/10000 to <1/1000; very rarely from <1/10000, including individual messages.

    From the respiratory system:

    Rarely: discomfort in the nose, dry nose, nosebleeds.

    Local reactions:

    Rarely: burning in the area of ​​application.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
    Overdose:Overdose with Vibrocil® can cause sympathomimetic effects, for example, heart palpitations, premature contraction of the ventricles of the heart, headache in the neck, tremor, fatigue, increased blood pressure, emotional arousal, insomnia, pale skin. The drug can also cause mild sedation, dizziness, a feeling of pain in the stomach, nausea, vomiting.
    Treatment: the use of activated carbon, laxatives; in adults and children older than 6 years - receiving a large amount of fluid. There is no specific antidote.Increased arterial pressure caused by phenylephrine can be eliminated by the use of alpha-blockers.
    Interaction:

    Phenylephrine (as well as other vasoconstrictors) is contraindicated in patients receiving MAO inhibitors at this time or receiving them during the previous 2 weeks.

    Do not prescribe the drug simultaneously with tri- and tetracyclic antidepressants, beta-blockers.

    Special instructions:

    Vibrocil® in the form of a gel is especially indicated in case of dryness of the nasal mucosa, in the presence of crusts, with the consequences of a nose injury, and also to prevent nasal congestion at night. Vibrocil® should not be used continuously for more than 7 days without consulting a doctor. Prolonged or excessive use of the drug can cause tachyphylaxis and the effect of "rebound" associated with the repeated development of nasal congestion (drug rhinitis), lead to the development of systemic vasoconstrictive action.

    Do not exceed the recommended dose of Vibrocil®! Otherwise, it is possible to develop manifestations of systemic effects of the drug, especially in children and elderly patients.

    Children under the age of 6 years only use drops in the nose.

    Vibrocil® does not have a sedative effect (does not affect the rate of psychomotor reactions).

    Form release / dosage:Gel nasal for 12 g.
    Packaging:

    In aluminum tubes with a tip and plastic lid. Tube with the instruction is placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 30 ° C.

    Keep out of the reach of children.

    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N015192 / 01
    Date of registration:10.10.2008 / 10.03.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom
    Information update date: & nbsp09.01.2017
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