Mirvazo Derm gel for external use 0.5%, 30g

Composition

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of 1 g of gel contains:

Active ingredient:

Brimonidine tartrate – 5.0 mg.

Auxiliary substances:

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

Pharmacological action

Erythema of the face with rosacea the remedy is alpha 2-adrenomimetic selective. Brimonidine is a highly selective alpha-2-adrenergic receptor agonist: its affinity for alpha-2-adrenergic receptors is 1000 times higher than that for alpha-1-adrenergic receptors.

Application of a highly selective alpha-2-adrenergic receptor agonist to the face leads to a decrease in erythema due to direct vasoconstriction of the skin vessels.

Clinical pharmacology

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 actively metabolized in the liver.

Deduction

Brimonidine and its metabolites are mainly excreted through the kidneys.

Indications

Treatment of facial erythema with rosacea.

Recommendations for use

For external use only.

A small amount of gel is applied in a thin layer to the skin of each of the 5 zones of the face (forehead, chin, nose, cheeks) 1 time a day in the presence of 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 Mirvazo®gel The dermis should be spread evenly in a thin layer over the face, avoiding contact with the drug in the eyes, eyelids, lips, mouth and nasal mucosa. The gel should only be applied to the face.

Contraindications

-Hypersensitivity to brimonidine or to any of the excipients; – children under 18 years of age (safety and efficacy of the drug for this age category have not been established);- 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. With caution: – Pregnancy; – impaired liver and kidney function.

Side effects

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 studies. As a rule, these were mild or moderate reactions that 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-marketing period, there were frequent cases of increased redness, hyperemia, and burning sensation of the skin. Cases of facial swelling and urticaria were noted as infrequent.

Adverse reactions reported in clinical trials (see Table 1) are classified by organ system and frequency of development. The frequency of adverse reactions was classified as follows: very common (>1/10), common (>>1/100 to >><1/10), uncommon (>1/1000 to <1/10), uncommon (><1/100), rare (>1/10000 to <1/100), rare (><1/1000), very rare ( Table 1

* Data on side effects obtained in the post-marketing period.

Interaction

Studies on the interactions of the drug 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, it is necessary to consider the possibility of additional or potentiating effects when brimonidine is co-administered with substances that depress the central nervous system (alcohol, barbiturates, opiates, sedatives or anesthetics). There are no data on the effect of brimonidine on the level of circulating catecholamines. However, 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. Caution is recommended when using brimonidine concomitantly or changing its dose in the treatment of ophthalmic diseases. Caution is recommended when starting treatment or changing the dose of co-administered systemic drugs (regardless of their dosage form) that may interact with alpha-adrenergic receptor agonists or affect their activity, i. e., are agonists or antagonists of adrenergic receptors (for example, isoprenaline, prazosin). In some patients, brimonidine can cause a clinically insignificant decrease in blood pressure, so caution should be exercised when using drugs such as antihypertensive agents and/or cardiac glycosides simultaneously with brimonidine.

Overdose

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

If the drug is accidentally administered orally, such phenomena of overdose with alpha-2 receptor agonists as hypotension, weakness, vomiting, drowsiness, lethargy, bradycardia, arrhythmia, miosis, apnea, hypotension, hypothermia, respiratory depression and convulsions are possible.

During the clinical trial,2 cases of serious adverse events were observed due to accidental ingestion of Mirvazo ® Dermis by young children. The symptoms observed in children corresponded to the known symptoms of alpha-2 receptor agonist overdose in young children and completely disappeared within 24 hours.

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

Description

Opaque gel of white to light yellow color.

Special instructions

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

After using the drug, it is necessary to wash your hands. Mirvazo ® Derm can be used in conjunction with other medications used to treat the inflammatory elements of rosacea. They can be applied to the skin only after Mirvazo® Derm has dried, and not simultaneously with it. After Mirvazo® Derm is applied and dried, cosmetics can be used. Erythema and hyperemia

The effect of Mirvazo ® Dermis begins to weaken a few hours after application. In some patients, the recurrence of erythema and transient hyperemia was described in a more severe form than was observed before treatment. Most cases of erythema were reported within the first 2 weeks after starting treatment.

Some patients experienced transient hyperemia. The time of onset of hyperemia after applying the gel ranged from 30 minutes to several hours.

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

If erythema worsens, the drug should be discontinued.Symptomatic measures, such as cooling down, taking nonsteroidal anti-inflammatory drugs, and antihistamines, can relieve symptoms.

Relapses of erythema and hyperemia exacerbations were reported after Mirvazo Dermis was resumed. However, if necessary, treatment can be resumed after the function of the skin barrier is restored, starting with a trial application of the drug to a small area of the face at least 1 day before the complete resumption of treatment of the entire facial skin.

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, as 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 diseases;

– depression, cerebral or coronary circulatory insufficiency, Raynaud’s disease, orthostatic hypotension, thromboangiitis obliterans, scleroderma or Sjogren’s syndrome.

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

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 dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

At a temperature not exceeding 30 °C. Do not freeze it. Keep out of reach of children.

Shelf

life is 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.

Active ingredient

Brimonidine

Conditions of release from pharmacies

By prescription

Dosage form

gel for external use