Mirvaso Derm gel for external use 0.5%, 30g

Treatment of facial erythema in rosacea.

For external use only.

A small amount of gel is applied in a thin layer to the skin of each of the 5 areas of the face (forehead, chin, nose, cheeks) once a day in the presence of erythema.

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

When applied to the skin, Mirvazo * Derm gel must be distributed evenly in a thin layer over the face, avoiding contact with the eyes, eyelids, lips, mouth and nasal mucosa. The gel should only be applied to the face.

Brimonidine tartrate - 5.0 mg

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

Х Hypersensitivity to brimonidine or to any of the excipients;

Х Children under 18 years of age (the safety and efficacy of the drug for this age category has not been established);

Х Concomitant 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.

Carefully

Х Pregnancy;

Х Dysfunction of the liver and kidneys.

Trade name of the drug:

Mirvaso * Derm

International non-proprietary name:

Brimonidine

Dosage form:

gel for external use

Composition:

1 g of gel contains:

Active substance:

Brimonidine tartrate - 5.0 mg

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

Description:

Opaque white to light yellow gel.

Pharmacotherapeutic group:

erythema of the face with rosacea means of treatment - selective alpha-adrenergic agonist.

ATX code: D11AX21

Pharmacological properties

Pharmacodynamics

Brimonidine is a highly selective agonist of alpha-adrenergic receptors: its affinity for alpha-adrenergic receptors is 1000 times higher than that for alpha) -adrenergic receptors.

Application to the skin of the face of a highly selective alpha: -adrenergic receptor agonist leads to a decrease in erythema due to direct vasoconstriction of the skin vessels.

Pharmacokinetics

Suction

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

Metabolism

Brimonidine is extensively metabolized in the liver.

Withdrawal

Brimonidine and its metabolites are excreted primarily through the kidneys.

Indications for use

Treatment of facial erythema in rosacea.

Contraindications

Х Hypersensitivity to brimonidine or to any of the excipients;

Х Children under 18 years of age (the safety and efficacy of the drug for this age category has not been established);

Х Concomitant 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.

Carefully

Х Pregnancy;

Х Dysfunction of the liver and kidneys.

Application during pregnancy and during breastfeeding

Pregnancy

Data on the use of brimonidine during pregnancy are limited or absent. Reproductive toxicity studies in animals have not revealed direct or indirect adverse effects of the drug. As a precautionary measure, it is recommended to avoid the use of Mirvazok Derm during pregnancy. Breastfeeding period

It is not known whether brimonidine and its metabolites pass into breast milk. Therefore, the risk to newborns and infants cannot be ruled out. The drug Mirvazo * Derm should not be used during breastfeeding.

Method of administration and dosage

For external use only.

A small amount of gel is applied in a thin layer to the skin of each of the 5 areas of the face (forehead, chin, nose, cheeks) once a day in the presence of erythema.

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

When applied to the skin, Mirvazo * Derm gel must be distributed evenly in a thin layer over the face, avoiding contact with the eyes, eyelids, lips, mouth and nasal mucosa. The gel should only be applied to the face.

Side effects

The most common 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 reactions of mild to moderate severity, which did not lead to discontinuation of treatment. There was no significant difference in the safety profile between elderly patients and patients aged 18 to 65 years. In the post-registration period, there were frequent cases of increased redness, hyperemia and a burning sensation of the skin. Facial swelling and urticaria were reported as infrequent.

Overdose

There is no information about an overdose of brimonidine with external use in adult patients.

In case of accidental use of the drug inside, such phenomena of an overdose of alpha-receptor agonists are possible, such as hypotension, weakness, vomiting, drowsiness, lethargy, bradycardia, arrhythmia, miosis. apnea, hypotension, hypothermia, respiratory depression and seizures.

In a clinical study, 2 cases of serious adverse events were noted caused by accidental ingestion of Mirvazo * Derm by young children. The symptoms observed in children were consistent with the known symptoms of an overdose of alpha agonists in young children and disappeared completely within 24 hours.

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

Interaction with other medicinal products

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

Brimonidine is contraindicated in patients taking monoamine oxidase (MAO) inhibitors, and in patients taking tricyclic and tetracyclic antidepressants that affect noradrenergic transmission. sedatives or anesthetics).

There are no data on the effect of brimonidine on the level of circulating catecholamines.

However, caution is advised 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 with the simultaneous use of brimonidine or changing its dose in the treatment of ophthalmic diseases.

Caution is advised when starting treatment or changing the dose of co-administered systemic drugs (regardless of their dosage form) that may interact with or interfere with alpha-adrenergic receptor agonists, 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, therefore, caution should be exercised when using drugs such as antihypertensive drugs and / or cardiac glycosides, simultaneously with brimonidine.

special instructions

Mirvazo * Derm should not be applied to irritated skin or open wounds, or to the area around the eyes. In case of severe irritation or allergy, it is necessary to interrupt the drug treatment.

After using the drug, be sure to wash your hands. The drug Mirvazo Derm can be used in conjunction with other drugs used to treat the inflammatory elements of rosacea. They can be applied to the skin only after the Mirvaso Derm preparation has dried, and not simultaneously with it. After application and drying of the Mirvazo * Derm preparation, it is possible to use cosmetics.

The effect of the drug Mirvazok Derm begins to weaken a few hours after application. In some patients, the resumption of erythema and transient hyperemia in a more severe form than was observed before treatment was described. Most cases of erythema occurred within the first 2 weeks after starting treatment.

In some patients, transient hyperemia was observed. The time of the onset of hyperemia after application of the gel varied from 30 minutes to several hours.

In most cases, erythema and hyperemia resolved after discontinuation of the drug.

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

After the resumption of the use of the drug Mirvazo Derm, relapses of exacerbations of erythema and hyperemia were noted. However, if necessary, treatment can be resumed after the restoration of the function of the skin barrier, starting with a trial application of the drug to a small area of ??the face at least 1 day before the full resumption of treatment for the entire skin of the face.

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

It is necessary to avoid increasing the maximum daily dose and / or frequency of use, since the safety of increased daily doses or repeated daily use has not been established.

Concomitant use with systemic alpha-adrenergic receptor agonists may increase the side effects of this class of drugs in patients with:

- severe or uncontrolled or unstable cardiovascular disease;

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

Mirvac / Derm contains methyl parahydroxybenzoate, which can cause allergic reactions (possibly delayed), and propylene glycol, which can irritate the skin.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect or slightly affects the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form

Gel for external use 0.5%.

10 g or 30 g of gel in a laminated plastic tube (PE / AL / PE) with a high-density polyethylene (HDPE) neck and a child-resistant polypropylene (PP) screw cap; 1 tube with instructions for use in a cardboard box.

Vacation conditions

On prescription.

Storage conditions

At a temperature not higher than 30 ? C. Do not freeze.

Keep out of the reach of children.

Shelf life of the drug

2 years.

After the first opening, store the drug for no more than 6 months at a temperature not exceeding 25 ? C.

Do not use after the expiration date.