Mirvaso Derm instruction
You can buy gel Mirvaso Derm here
Treatment of face erythema with rosacea.
- hypersensitivity to brimonidine or to any of the excipients;
- children's age up to 18 years (safety and efficacy of the drug for this age category has not been established);
- simultaneous use with monoamine oxidase (MAO) inhibitors (for example, selegiline or moclobemide), and tricyclic (imipramine) and tetracyclic (maprotiline, mianserin and mirtazapine) antidepressants that affect noradrenergic transmission.
- impaired liver and kidney function.
Pregnancy and lactation
Data on the use of brimonidine during pregnancy is limited or absent. Animal reproductive toxicity studies revealed no direct or indirect adverse effects of the drug. As a precautionary measure, it is recommended to avoid the use of Mirvaso Derm during pregnancy.
It is not known whether brimonidine and its metabolites pass into breast milk. In this regard, it is impossible to eliminate the risk for newborns and infants. The drug Mirvaso Derm should not be used during breastfeeding.
Active ingredient: brimonidine.
Release form: Gel for external use of 0.5% 30 g.
Mode of application
For external use only.
A small amount of the gel is applied in a thin layer on the skin of each of the 5 facial areas (forehead, chin, nose, cheeks) 1 time per day in the presence of erythema.
The maximum recommended daily dose of the drug, divided into 5 parts in accordance with the areas of application, is 1 g.
When applied to the skin, Mirvaso Derm Gel should be spread evenly in a thin layer over the face, avoiding contact with the eyes, eyelids, lips, mouth and nasal mucosa. The gel should be applied only to the face.
Research on the interaction of the drug with other drugs was not conducted.
Brimonidine is contraindicated in patients taking monoamine oxidase inhibitors (MAO), and patients taking tricyclic and tetracyclic antidepressants that affect noradrenergic transmission. Consider the possibility of an additional or potentiating action when brymonidine is used jointly with substances that suppress the central nervous system (alcohol, a background, a white background, a background, or a background, a man, or a background, a man, a background, or a background, or a background, or a background, has been used. sedatives or anesthetics).
Data on the effect of brimonidine on the level of circulating catecholamines are not available. Nevertheless, caution is recommended in patients receiving drugs that can affect the metabolism of amines and increase their concentration in the blood, such as chlorpromazine, methylphenidate, reserpine.
It is recommended to be careful when using brimonidine at the same time or changing its dose in the treatment of ophthalmologic diseases.
It is recommended to be careful in starting treatment or changing the dose of co-administered systemic drugs (regardless of their dosage form) that can interact with alpha adrenergic receptor agonists or affect their activity, i.e., are adrenergic receptor agonists or antagonists (for example, isoprenaline, prazosin).
In some patients, brimonidine can cause a clinically insignificant decrease in blood pressure, so care should be taken when using drugs such as antihypertensive drugs and / or cardiac glycosides, along with brimonidine.
Side Effects of Mirvaso Derm
The most frequent adverse reactions, including redness, itching, flushing and burning sensation of the skin, were observed in patients in 1.2-3.3% of cases during clinical trials. As a rule, these were mild or moderate reactions that did not lead to cessation of treatment.
There was no significant difference in safety profile in elderly patients and patients aged 18 to 65 years.
In the post-registration period, there were frequent cases of increased redness, redness and burning sensation of the skin. Cases of swelling of the face and urticaria were noted as infrequent.
The undesirable reactions obtained during clinical trials (see Table 1) are classified according to organ systems and the frequency of development. The frequency 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), frequency unknown (impossible to estimate, based on available data).
Nervous system disorders:
Infrequently - Headache, paresthesias.
Violations by the organ of vision:
Infrequently - Edema of the eyelids.
Often - G iperemiya.
Disorders of the respiratory system, chest and mediastinal organs:
Infrequently - Nasal congestion.
Disorders of the gastrointestinal tract:
Infrequently - Dry mouth.
Violations of 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, skin soreness, skin discomfort, papular rash, acne, facial swelling *, urticaria *.
General disorders and disorders at the site of administration:
Infrequently - Feeling hot, feeling cold in limbs.
* Data on adverse events obtained in the post-registration period.
Do not apply Mirvaso Derm on irritated skin or open wounds, on the area around the eyes. In case of severe irritation or allergy, it is necessary to interrupt the treatment with the drug.
After using the drug, be sure to wash your hands. The drug Mirvaso Derm can be used in conjunction with other drugs used to treat inflammatory elements of rosacea. They can be applied to the skin only after the Mirvaso Derm has dried, and not simultaneously with it. After application and drying of Mirvaso Derm it is possible to use cosmetics. Erythema and hyperemia
The effect of Mirvaso Derm begins to wane after a few hours after application. In some patients, the resumption of erythema and transient hyperemia in a more severe form than that observed before treatment has been described. Most cases of erythema were observed during the first 2 weeks after the start of treatment.
Transient hyperemia was observed in some patients. The time of onset of hyperemia after applying the gel ranged from 30 minutes to several hours.
In most cases, erythema and hyperemia passed after discontinuation of the drug.
In case of aggravation of erythema, use of the drug should be discontinued. Symptomatic measures, such as cooling, taking nonsteroidal anti-inflammatory drugs and antihistamines, can alleviate symptoms.
After the resumption of the use of Mirvaso Derm, recurrences of exacerbations of erythema and hyperemia were noted. However, if necessary, treatment can be resumed after restoration of the skin barrier function, starting with a trial application of the drug on a small area of the face no less than 1 day before the full resumption of treatment of the entire skin of the face.
It is necessary to strictly observe the recommended dose and frequency of application: once a day, in a very thin layer.
It is necessary to avoid increasing the maximum daily dose and / or frequency of use, as the safety of increased daily doses or repeated daily use has not been established.
Simultaneous use of alpha adrenergic receptors with systemic agonists may enhance the side effects of this class of drugs in patients with:
- severe or uncontrolled, or unstable cardiovascular diseases;
- depression, cerebral or coronary blood circulation insufficiency, Raynaud's disease, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjogren's syndrome.
Mirvaso Derm contains methyl parahydroxybenzoate, which can cause allergic reactions (possibly of a delayed type), as well as propylene glycol, which can cause skin irritation.
Impact on the ability to drive trans. Wed and fur .
The drug does not affect or slightly affects the ability to drive vehicles or engage in other potentially dangerous activities that require increased concentration and psychomotor speed.
At a temperature not higher than 30 ° C.
Terms of sell
You don't need a prescription to buy Mirvaso Derm.