Mirwazo® Derm (Mirvaso® Derm)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBrimonidineBrimonidine
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  • Mirwazo® Derm
    gel externally 
    Galderma S.A.     Switzerland
    • Dosage form: & nbspDSpruce for external use.
    Composition:

    1 g of gel contains:

    Active substance:

    Brimonidine tartrate 5.0 mg.

    Excipients: carbomer 12.5 mg, methylparahydroxybenzoate 1.0 mg, phenoxyethanol 4.0 mg, glycerol 55.0 mg, titanium dioxide 0.625 mg, propylene glycol 55.0 mg, sodium hydroxide to pH 6.0, purified water - up to 1000 mg.

    Description:

    Opaque gel from white to light yellow color.

    Pharmacotherapeutic group:erythema of the face with rosacea treatment - alpha2-adrenomimetic selective
    ATX: & nbsp

    S.01.E.A   Sympathomimetics for the treatment of glaucoma

    S.01.E.A.05   Brimonidine

    Pharmacodynamics:

    Brimonidine is a highly selective alpha agonist2-adrenergic receptors: its affinity for alpha2-adrenergic receptors is 1000 times greater than the affinity for alpha1-adrenergic receptors.

    Applying to the skin of a highly selective alpha agonist2-adrenergic receptors leads to a decrease in erythema due to direct vasoconstriction of the skin vessels.

    Pharmacokinetics:

    Suction

    The absorption of brimonidine from Mirwazo® Derm was studied in a clinical trial in 24 adult patients with erythema of the face with rosacea.With daily single application to the skin of the face for 29 days, no accumulation of the drug in the blood plasma was observed.

    Metabolism

    Brimonidine is actively metabolized in the liver.

    Excretion

    Brimonidine and its metabolites are excreted mainly through the kidneys.

    Indications:

    Treatment of facial erythema with rosacea.

    Contraindications:

    - Hypersensitivity to brimonidine or any of the excipients;

    - dEthnic age to 18 years (safety and efficacy of the drug for this age group is not established);

    - aboutsimultaneous administration with monoamine oxidase (MAO) inhibitors (eg, selegiline or moclobemide), and tricyclic (imipramine) and tetracyclic (maprotiline, mianserin and mirtazapine) antidepressants, which affect the noradrenergic transmission.

    Carefully:

    - Pregnancy;

    - impaired liver and kidney function.

    Pregnancy and lactation:

    Pregnancy

    Data on the use of brimonidine in pregnancy are limited or absent. Studies of reproductive toxicity in animals have not revealed any direct or indirect adverse effects of the drug.As a precaution, it is recommended to avoid the use of Mirwazo® Dermis during pregnancy.

    Breastfeeding period

    It is not known whether the brimonidine and its metabolites into breast milk. In this regard, it is impossible to exclude the risk for newborns and infants. The drug Mirwazo® Derm should not be used during breastfeeding.

    Dosing and Administration:

    For external use only.

    A small amount of gel is applied to the skin of each of the 5 face zones (forehead, chin, nose, cheeks) once a day with erythema.

    The maximum recommended daily dose of the drug, divided into 5 parts according to the application areas, is 1 g.

    When applied to the skin gel Mirvazo® Dermis should be spread evenly in a thin layer over the face, avoiding getting the drug into the eyes, eyelids, lips, mouth and nasal mucosa. The gel should be applied only to the face.

    Side effects:

    The most frequent unwanted reactions, including redness, itching, flushing and burning sensation of the skin, were noted in patients in 1.2-3.3% of cases in clinical trials.As a rule, these were reactions of mild or moderate severity that did not lead to cessation of treatment.

    There was no significant difference in the safety profile of elderly patients and patients aged 18 to 65 years.

    During the post-registration period, frequent cases of increased redness, hyperemia and burning sensation of the skin were noted. Cases of swelling of the face and urticaria were noted as infrequent.

    Undesirable reactions obtained during clinical trials (see Table 1) are classified according to organ systems and frequency of development. The incidence of adverse reactions was classified as follows: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1000 to <1/100), rarely (> 1/10000 to < 1/1000), very rarely (<1/10000), the frequency is unknown (it is impossible to estimate from the available data). Table 1

    Class of organ systems

    Frequency occurrence

    Undesirable reactions

    Disturbances from the nervous system

    Infrequently

    Headache, paresthesia.

    Disturbances on the part of the organ of sight

    Infrequently

    Edema of the eyelids.

    Vascular disorders

    Often

    Hyperemia.

    Disturbances from the respiratory system, chest and mediastinal organs

    Infrequently

    Nasal congestion.

    Disorders from the gastrointestinal tract

    Infrequently

    Dryness in the mouth.

    Disturbances from the skin and subcutaneous tissues

    Often

    Redness, itching, burning sensation of the skin.

    Infrequently

    Rosacea, dermatitis, skin irritation, sensation of heat on the skin, contact dermatitis, allergic contact dermatitis, dry skin, tenderness of the skin, skin discomfort, papular rash, acne, swelling of the face *, urticaria *.

    General disorders and disorders at the site of administration

    Infrequently

    Feeling of heat, cold feeling in the limbs.

    * Data on adverse events received during the post-registration period.

    Overdose:

    Information about the overdose of brimonidine in external application in adult patients is absent.

    In case of accidental use of the drug inside, such phenomena of overdose with alpha agonists2-receptors, like hypotension, weakness, vomiting, drowsiness, inhibition, bradycardia, arrhythmia, miosis, apnea, hypotension, hypothermia, respiratory depression and convulsions.

    In a clinical study, there were 2 cases of serious adverse events caused by accidental ingestion of Mirwazo® Derm by young children.Observed in children, the symptoms corresponded to known symptoms of an overdose of alpha agonists2-receptors in young children and completely disappeared within 24 hours.

    Treatment of overdose when taking the drug inside includes supportive and symptomatic therapy, it is necessary to maintain the patency of the airways.

    Interaction:

    Studies on the study of drug interactions with other drugs have not been conducted.

    Brimonidine is contraindicated in patients taking monoamine oxidase inhibitors (MAO) and patients receiving tricyclic and tetracyclic antidepressants affecting noradrenergic transmission must consider the possibility of extension or potentiating effect in the combined use of brimonidine with substances depressing the central nervous system (alcohol, barbiturates, opioids, sedatives or anesthetics).

    Data on the effect of brimonidine on the level of circulating catecholamines are absent. However, we recommend caution in patients receiving drugs that can affect the metabolism of amines and to increase their concentration in the blood, such as chlorpromazine, methylphenidate, reserpine.

    It is advisable to use caution when concomitantly applying brimonidine or changing its dose in the treatment of ophthalmic diseases.

    It is advisable to take care when starting treatment or changing the dose of co-administered systemic drugs (regardless of their dosage form) that can interact with or influence the activity of alpha-adrenergic receptor agonists, ie, they are adrenergic receptor agonists or antagonists (for example, isoprenaline, prazozin).

    In some patients brimonidine can cause a clinically insignificant decrease in blood pressure, so caution should be exercised when using drugs such as antihypertensives and / or cardiac glycosides, concomitantly with brimonidine.

    Special instructions:

    The drug Mirvazo® Derm should not be applied to irritated skin or open wounds, to the area around the eyes. In case of severe irritation or allergy, discontinue drug treatment.

    After applying the drug, you must wash your hands. The drug Mirwazo® Derm can be used in conjunction with other medicines used to treat inflammatory elements of rosacea.They can be applied to the skin only after the Mirvaso® Derm product dries, and not simultaneously with it. After applying and drying the drug Mirvazo® Derm it is possible to use cosmetics. Erythema and hyperemia

    The effect of Mirwazo® Derm is beginning to subside a few hours after application. Some patients described the resumption of erythema and transient hyperemia in a more severe form than was observed before treatment. Most of the cases of erythema were noted during the first 2 weeks after the start of treatment.

    Some patients experienced transient hyperaemia. The time of onset of hyperemia after application of the gel varied from 30 minutes to several hours.

    In most cases, erythema and hyperemia occurred after drug withdrawal.

    In case of aggravation of erythema, the drug should be discontinued. Symptomatic measures, such as cooling, taking non-steroidal anti-inflammatory drugs and antihistamines, can relieve symptoms.

    After the resumption of Mirvazo® Derm use, relapses of exacerbations of erythema and hyperemia were noted.However, if necessary, treatment can be resumed after restoration of the function of the skin barrier, starting with a trial application of the drug on a small area of ​​the face not less than 1 day before the full resumption of treatment of all skin of the face.

    The recommended dose and frequency of application should be strictly observed: once a day, with a very thin layer.

    Avoid increasing the maximum daily dose and / or frequency of use, since safety of increased daily doses or repeated daily use is not established.

    The simultaneous use of alpha-adrenergic receptors with systemic agonists can enhance the side effects of this class of drugs in patients with:

    - severe or uncontrolled, or unstable cardiovascular diseases;

    - depression, cerebral or coronary circulation insufficiency, Raynaud's disease, orthostatic hypotension, obliterating thromboangiitis, scleroderma, or Sjogren's syndrome.

    The composition of Mirvazo® Derm is methyl parahydroxybenzoate, which can cause allergic reactions (possibly, delayed type), as well as propylene glycol, which can lead to skin irritation.

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

    The drug has little or no effect on the ability to drive or engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

    Form release / dosage:Gel for external use, 0,5%.
    Packaging:

    10 g or 30 g of gel in a laminated plastic tube (PE / AL / PE) with a high-density polyethylene (HDPE) neck with a screw cap made of polypropylene (PP) with protection from opening by children; 1 tube with instructions for use in a cardboard box.

    Storage conditions:At a temperature of no higher than 30 ° C. Do not freeze.
    Keep out of the reach of children.
    Shelf life:

    2 years.

    After the first opening, store the drug for no longer than 6 months, at a temperature of no higher than 25 ° C.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003563
    Date of registration:12.04.2016
    Expiration Date:12.04.2021
    The owner of the registration certificate: Galderma S.A. Galderma S.A. Switzerland
    Manufacturer: & nbsp
    Representation: & nbspGALDERMA, LLCGALDERMA, LLCRussia
    Information update date: & nbsp16.06.2016
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