Mirvazo Derm - Instructions For The Use Of The Gel, Reviews, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Mirvaso Derm

Mirvazo Derm: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Mirvaso Derm

ATX code: D11AX21

Active ingredient: brimonidine (Brimonidine)

Manufacturer: Laboratories Galderma (France)

Description and photo update: 09.10.2019

Prices in pharmacies: from 1578 rubles.

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Mirvaso Derm is a drug intended for the treatment of facial erythema in rosacea.

Release form and composition

The drug is produced in the form of a gel for external use: opaque, from pale yellow to white (10 or 30 g each in a laminated plastic tube with a screw cap made of polypropylene and protection against opening by children, in a cardboard box 1 tube and instructions for use Mirvaso Derm).

1 g of gel contains:

• active substance: brimonidine tartrate - 5 mg;
• additional components: methyl parahydroxybenzoate, titanium dioxide, carbomer, glycerol, phenoxyethanol, sodium hydroxide, propylene glycol, purified water.

Pharmacological properties

Pharmacodynamics

Brimonidine belongs to highly selective agonists of α ₂ -adrenergic receptors: its affinity for α ₂ -adrenergic receptors is 1000 times higher than the affinity for α ₁ -adrenergic receptors.

When the gel is applied to the skin of the face, erythema decreases as a result of direct vasoconstriction (narrowing of the lumen) of the skin vessels.

Pharmacokinetics

The absorption of brimonidine, which is part of Mirvaso Derm, was studied in a clinical study in which 24 adult patients with facial erythema with rosacea took part. The accumulation of the active substance in the blood plasma against the background of a single daily application of the drug to the skin of the face for 29 days was not recorded.

The metabolic transformation of the agent actively proceeds in the liver. Brimonidine and its metabolites are excreted mainly by the kidneys.

Indications for use

Mirvaso Derm is recommended for the treatment of facial erythema in rosacea.

Contraindications

Absolute:

• age up to 18 years;
• breast-feeding;
• simultaneous use with monoamine oxidase (MAO) inhibitors (selegiline, moclobemide) and tricyclic (imipramine) and tetracyclic (mirtazapine, mianserin and maprotiline) antidepressants that affect noradrenergic transmission;
• hypersensitivity to any component of the product.

Relative (Mirvaso Derm gel should be used with extreme caution):

• violations of the liver and / or kidneys (studies of the use of the drug in patients from this risk group have not been conducted);
• pregnancy (in exceptional cases and only as prescribed by a doctor).

Mirvazo Derm, instructions for use: method and dosage

Mirvaso Derm gel is intended exclusively for external use. It only needs to be applied to the face.

In the presence of erythema, it is recommended to apply the product in a small amount with a thin layer 1 time per day on 5 areas - the skin of the forehead, chin, nose and cheeks. When treating the skin, the drug must be evenly distributed over the face, being careful not to get the product into the eyes, eyelids, lips, mucous membranes of the mouth and nose.

The maximum recommended daily dose of the gel, divided into 5 parts according to the areas of application, is 1 g, which is approximately equivalent to the size of 5 match heads. At the beginning of the course of therapy, a small amount of the drug should be used for at least 7 days (less than the maximum daily dose). In the future, taking into account the effectiveness and tolerability of the treatment, the amount of the applied gel can be gradually increased.

After completing the procedure, be sure to wash your hands.

Side effects

In the course of clinical studies, the most frequent adverse reactions recorded in patients in 1.2–3.3% of cases were itching, redness, hot flashes and a burning sensation of the skin. In most cases, these disorders were mild or moderate and did not require discontinuation of treatment. There are reports of cases of exacerbation of rosacea symptoms in persons using Mirvazo Derm. Based on the data of all conducted studies, these exacerbations were observed in 16% of patients.

In the post-registration period, frequent cases of worsening hot flashes, redness, burning sensation and pale skin in the area of application of the gel were recorded.

During the implementation of clinical trials, the following side effects of Mirvaso Derm were noted:

• cardiovascular system: often (> 1/100 to 1/10 000 to <1/1000) - arterial hypotension *;
• organ of vision: infrequently (> 1/1000 to <1/100) - eyelid edema;
• nervous system: infrequently - paresthesia, headache;
• gastrointestinal tract (GIT): infrequently - dry mouth;
• respiratory system, chest and mediastinal organs: infrequently - nasal congestion;
• skin and subcutaneous tissues: often - a burning sensation of the skin, itching, redness, blanching of the skin at the site of application *; infrequently - a feeling of warmth, skin irritation, rosacea, dry skin, dermatitis, skin soreness, acne, contact dermatitis, skin discomfort, allergic contact dermatitis, papular rash, urticaria *, facial swelling *; rarely - Quincke's edema *;
• general disorders: infrequently - a feeling of heat / cold at the site of application.

* Adverse reactions recorded in the post-registration period.

Overdose

There is no information on an overdose of brimonidine in adults with external use. In case of accidental oral administration of Mirvaso Derm, symptoms of an overdose of α ₂ -adrenoreceptor agonists may include such phenomena as weakness, lethargy, drowsiness, vomiting, arterial hypotension, hypothermia, miosis, arrhythmia, bradycardia, apnea, respiratory depression and convulsions.

During the clinical study, two cases of serious adverse reactions were recorded due to inadvertent ingestion of the gel by young children. The symptoms observed in children with this condition corresponded to the symptoms of an overdose of α ₂ -adrenoreceptor agonists and completely disappeared within 24 hours.

In case of accidental ingestion of the gel, supportive and symptomatic treatment is prescribed, measures are taken to ensure the maintenance of airway patency.

special instructions

The drug should not be applied to the eye area, irritated skin or open wounds. If severe irritation or allergy is observed, discontinue therapy.

Mirvaso Derm gel can be used in combination with other medications intended for the treatment of inflammatory elements in rosacea, as well as in conjunction with cosmetics. However, they can be applied to the skin only after the gel has dried, and not just before its application.

The effect of the drug begins to weaken a few hours after the procedure. In some patients, a resumption of erythema and hot flashes in a more severe form was noted compared to those observed before therapy. As a rule, such cases were recorded during the first 2 weeks after the start of the course of treatment. During therapy with the drug, some patients experienced hot flashes, the onset time of which varied from 30 minutes to several hours after the procedure. Usually, after the abolition of Mirvaso Derm, erythema and hot flashes passed. If, during therapy, an aggravation of erythema is observed, the use of the drug should be suspended. Taking non-steroidal anti-inflammatory drugs (NSAIDs) and antihistamines, cooling lotions, and other symptomatic measures can relieve symptoms.

After resuming the use of the gel, cases of exacerbation of erythema and hot flashes with a more severe course were recorded. When starting to use Mirvazo Derm after a temporary break in treatment, you first need to make a trial application of the gel on a small area of the skin of the face no later than 1 day before the preparation is applied to all areas of the face.

It is necessary to apply the gel only 1 time per day and in a very thin layer, avoiding increasing the maximum daily dose, since the safety of too high doses or multiple daily application of the gel has not been established.

In the presence of severe, uncontrolled or unstable cardiovascular diseases, depression, cerebral / coronary circulation insufficiency, Raynaud's disease, orthostatic hypotension, thromboangiitis obliterans, scleroderma or Sjogren's syndrome, simultaneous use with systemic α-adrenergic receptor agonists may aggravate the severity of this class of adverse drug reactions …

The composition of Mirvaso Derm includes methyl parahydroxybenzoate, which can lead to the development of allergic reactions (including delayed-type reactions), as well as propylene glycol, which can provoke skin irritation.

Influence on the ability to drive vehicles and complex mechanisms

Mirvazo Derm has no or insignificant effect on the ability to drive vehicles and operate other complex and potentially dangerous machinery.

Application during pregnancy and lactation

Information on the use of brimonidine during pregnancy is extremely limited or absent. In the process of preclinical studies of reproductive toxicity in animals, no direct or indirect negative effect of the drug was revealed. But, despite this, it is not recommended to use Mirvaso Derm as a precautionary measure for pregnant women.

Whether brimonidine and its metabolites are excreted in breast milk has not been established, therefore, it is impossible to exclude a threat to infants. During lactation, Mirvazo Derm should not be used. If a nursing woman needs drug therapy, it is necessary to resolve the issue of transferring the child to artificial feeding.

Pediatric use

For patients under 18 years of age, treatment with the drug is contraindicated: children under 2 years of age - due to significant systemic risk, children aged 2 to 18 years - due to the lack of data confirming the efficacy and safety of Mirvazo Derm for this age category.

With impaired renal function

In the presence of impaired renal function, use Mirvaso Derm with caution.

For violations of liver function

In the presence of liver dysfunction, it is recommended to use Mirvaso Derm with caution.

Use in the elderly

In clinical studies, no pronounced difference in the safety profile in the elderly and patients aged 18–65 years was found.

Drug interactions

Brimonidine has not been studied for interactions with other drugs / agents.

The simultaneous use of Mirvaso Derm with MAO inhibitors is contraindicated, since this leads to a deterioration in the absorption of brimonidine and an increase in the development of systemic side effects in the form of arterial hypotension, and also affects the metabolic process and the absorption of circulating amines.

Combinations of medicines requiring attention:

• ethanol, opiates, barbiturates, anesthetics or sedatives (drugs that depress the central nervous system): an additional or potentiating effect may be recorded;
• methylphenidate, chlorpromazine, reserpine (drugs that can affect the metabolism of amines and increase their level in the blood): care must be taken with these combinations, despite the fact that there is no information on the effect of brimonidine on the content of circulating catecholamines;
• prazosin, isoprenaline and other antagonists or agonists of α-adrenergic receptors are systemic drugs (regardless of their dosage form) that have the ability to interact with α-adrenergic receptor agonists or influence their effect: it is recommended to exercise caution at the beginning of the course of combination therapy or when adjusting the dose systemic drugs;
• cardiac glycosides, antihypertensive drugs: there may be a clinically insignificant decrease in blood pressure.

Analogs

The analogues of Mirvaso Derm are Luxfen, Brim Antiglau ECO, Alfagan R, Alfabrim.

Terms and conditions of storage

Store out of the reach of children, at a temperature not exceeding 30 ° C, without freezing.

Shelf life is 2 years.

After the first opening of the tube, the gel should be stored for no more than 6 months, at a temperature not exceeding 25 ° C.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Mirvaso Derm

Reviews of Mirvaso Derm, found on medical sites, are ambiguous. Almost all patients suffering from rosacea note the rapid (occurring within 10–30 minutes after application) effect of the drug, providing complete removal of redness, smoothing of complexion, and relief of rosacea manifestations for about 5–6 hours.

However, many patients are unhappy with the fact that the action of Mirvaso Derm is short-term, and after repeated use of the gel, a side effect very often occurs, sometimes quite long-term, in the form of aggravation of erythema and hot flashes. In some reviews, it is recommended, due to the short-term aesthetic effect of the gel, to use Mirvaso Derm only before some important events, and then use it as rarely as possible. The disadvantages of the tool also include its high cost.

The price of Mirvaso Derm in pharmacies

The price of Mirvaso Derm, a gel for external use, can be 1680-1880 rubles. for a tube of 30 g.

Mirvazo Derm: prices in online pharmacies

Drug name Price Pharmacy

Mirvaso Derm 0.5% gel for external use 30 g 1 pc. RUB 1578 Buy

Mirvaso Derm gel for outside. approx. 0.5% tube 30g 1750 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!