Pharmacotherapeutic group. Corticosteroids for dermatological use.
Methizolone, when applied topically, inhibits inflammatory and allergic skin reactions, as well as reactions associated with cell hyperproliferation, which eliminates both objective symptoms (erythema, edema, infiltration, lichenification) and subjective sensations (itching, burning, pain).
When methylprednisolone aceponate is applied in a dose that is effective for topical administration, the systemic effect is minimal in both humans and animals. When applied to large areas of skin in patients with skin diseases, the level of cortisol in plasma / blood remains within the normal range, and its circadian rhythm is not disturbed. Also, there was no decrease in the concentration of cortisol in the daily volume of urine. As with other glucocorticosteroids, the mechanism of action of methylprednisolone aceponate has not been fully elucidated. It is known that it directly binds to intracellular glucocorticoid receptors. This is especially true for the main metabolite, 6a-methylpred-nisolone-17-propionate, which is formed after cleavage in the skin. Binding of the receptor-steroid complex to a specific region of the DNA molecule initiates a number of biological effects.
The mechanism of anti-inflammatory action has been clarified more precisely. Binding of the receptor-steroid complex leads to the induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and thus reduces the production of inflammatory mediators such as prostaglandins and leukotrienes.
The immunosuppressive effect of glucocorticosteroids can be explained by the inhibition of cytokine synthesis and antimitotic effect, which has not yet been sufficiently studied.
Inhibition of the synthesis of vasodilatory prostaglandins or potentiation of the vasoconstrictor effect of adrenaline ultimately determines the vasoconstrictor activity of glucocorticosteroids.
Atopic dermatitis (endogenous eczema, neurodermatitis), contact eczema, degenerative, dyshidrotic, numular eczema, non-specific eczema, eczema in children.
Composition of the medicinal product:
active substance: 1 g of the preparation contains micronized methylprednisolone aceponate 1 mg;
excipients: butylhydroxyanisole (E 320), isopropyl myristate, white soft paraffin, peach oil, glycerol monostearate, cetostearyl alcohol, polyethylene glycol stearate, disodium edetate, glycerin, benzyl alcohol, purified water.
- Hypersensitivity to methylprednisolone aceponate or to any other component of the preparation;
- tuberculous and syphilitic processes in the area of preparationapplication; viral diseases (for example, chickenpox, shingles), rosacea, perioral dermatitis, ulcers, acne, atrophic skin diseases, reactions after vaccinations at the site of application of the preparation.
Special warnings.
In case of bacterial infectious processes of the skin and / or in the case of fungal infection, additional special treatment is necessary.
Avoid getting the preparation in the eyes, on deep open wounds, on mucous membranes.
If the skin dries out excessively after prolonged application of Metizolone cream, it is recommended to switch to a different dosage form of the preparation with a higher fat content.
Metizolone, an ointment for external use.
If you have or have had glaucoma in the past, you should inform your doctor.
As you know, with systemic corticosteroid therapy, glaucoma can also develop (for example, after application in high doses or over a large area for a long period, the use of occlusive dressings or application to the skin around the eyes).
When applying topical corticosteroids in high doses over large areas of the body or over a long period, especially under an occlusive dressing, the risk of side effects is significantly increased.
When the preparation Metizolone was applied to a large area of the skin (40-60% of the skin surface) or even when using occlusive dressings, neither adults nor children were observed to dysfunctions of the adrenal cortex. Despite this, when applying the preparation to a large area of the skin, the duration of treatment should be as short as possible.
To date, there is no reliable data on the use of the preparation by pregnant women.
Usually in the 1st trimester of pregnancy, the external use of preparations containing corticosteroids (in particular, Metizolone) should be avoided.
It is necessary to take into account the risk-benefit ratio when prescribing the preparation to pregnant women.
During breastfeeding, the cream should not be applied to the mammary glands. Long-term use of the preparation or its application to large areas of the skin should be especially avoided.
The ability to influence the reaction rate when driving or operating other mechanisms. Not installed.
Children. No specific caveats are described.
Usually, the preparation is applied to the affected skin once a day with a thin layer, unless the doctor has prescribed otherwise. The duration of use should usually not exceed 12 weeks for adults, 4 weeks for children.
No risk is expected in case of excessive single use (application of the preparation over a large area of the skin) or unintentional oral ingestion.
Like all medicines, this medicine can cause side effects.
During clinical trials, the most common side effects when applying the cream were burning and itching at the site of application.
The frequency of side effects is determined according to the MedDRA side effect frequency convention: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1 000); very rare (<1/10 000), unknown (frequency cannot be estimated from available data). MedDRA version 12.0 was used for encoding.
| Organs and systems | Often | Infrequently | Редко |
| General disorders and reactions at the site of application | Burning, itching at the site of application | Dryness, erythema, vesicles, folliculitis, rashes, parasthesia at the site of application | Cellulite, edema, irritation at the site of application |
| Immune system | Hypersensitivity to preparation components | ||
| Skin and subcutaneous tissue | Pyoderma, skin cracks, telangiectasia, skin atrophy, fungal skin infections, acne |
As with the topical use of other corticosteroids, side effects such as thinning of the skin (skin atrophy), telangiectasia, stretch marks, acne-like skin rashes, inflammation of the hair follicles (folliculitis), excessive hair growth (hypertrichosis), perioral dermatitis, discoloration of the skin, allergic skin reactions to any of the components of the preparation. In some cases, with prolonged use, a systemic effect of corticoids is possible due to their absorption.
Interaction with other medicinal products and other types of interactions.
No data.
Shelf life. 2 years.
Store in its original packaging at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
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