Mirvazo Derm, gel 0.5% 30 g

Facial erythema in rosacea treatment is an alpha2-adrenomimetic selective.

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

Application of a highly selective alpha2-adrenergic receptor agonist to the face results in reduction of erythema due to direct vasoconstriction of skin vessels.

Indications

Active ingredient

Composition

1 g of the gel contains:

Active substance:

Brimonidine tartrate – 5.0 mg.

Auxiliary substances:

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,

Interaction

Directions for use

For external use only.

A small amount of gel is applied in a thin layer to 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 product, divided into 5 parts according to the areas of application, is 1 g.

When applied to the skin, Mirvazo® 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 only be applied to the face.

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, treatment with the drug should be discontinued.

Wash hands after using the drug. Mirvazo® Derm can be used together with other medications used for the treatment of inflammatory elements of rosacea. They can be applied to the skin only after Mirvazo® Derm has dried and not simultaneously with it. After application and drying of Mirvazo® Derm, it is possible to use cosmetics. Erythema and hyperemia

The effects of Mirvazo® Derm begin to subside a few hours after application. Some patients have described a recurrence of erythema and transient hyperemia more severe than those seen before treatment. Most cases of erythema were noted within the first 2 weeks of treatment.

Transient hyperemia was observed in some patients. The time of onset of hyperemia after application of the gel ranged from 30 minutes to several hours.

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

If the erythema worsened, the drug should be discontinued. Symptomatic measures, such as cooling, non-steroidal anti-inflammatory drugs, and antihistamines can relieve symptoms.

Recurrences of exacerbations of erythema and hyperemia have been reported after resumption of Mirvazo® Derm. However, if necessary, treatment can be resumed after the skin barrier has been restored, starting with a trial application to a small area of the face for at least 1 day before resuming treatment of the entire face.

The recommended dose and frequency of application must be strictly adhered to: once daily, in a very thin layer.

A higher maximum daily dose and/or frequency of use should be avoided, as the safety of higher daily doses or multiple daily applications has not been established.

Simultaneous 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, cerebral or coronary circulatory insufficiency, Raynaud’s disease, orthostatic hypotension, obliterating thromboangiitis, scleroderma, or Sjögren’s syndrome.

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

The drug has no or little effect on the ability to drive vehicles or engage in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Contraindications

Side effects

The most frequent adverse reactions, including redness, itching, hyperemia, 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 mild to moderate reactions that did not lead to discontinuation of treatment.

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

In the post-registration 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.

The 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), infrequent (>1/1000 to <1/100), rare (>1/10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated based on available data). Table 1

Class of organ systems

Frequency of occurrence

Adverse reactions

Nervous system disorders

Infrequent

Feeling hot, feeling cold in extremities.

*Data on adverse effects obtained in the post-registration period.

Overdose

There is no information about brimonidine overdose when used externally in adult patients.

Inadvertent oral administration of the drug may cause alpha2 receptor agonist overdose, such as hypotension, weakness, vomiting, drowsiness, lethargy, bradycardia, arrhythmia, miosis, apnea, hypotension, hypothermia, respiratory depression and seizures.

In a clinical study, there were 2 cases of serious adverse events caused by accidental ingestion of Mirvazo® Derm in young children. The symptoms observed in children were consistent with known symptoms of alpha2-receptor agonist overdose in young children and disappeared completely within 24 hours.

The treatment of overdose when taking the drug orally includes supportive and symptomatic therapy; airway patency should be maintained.