Advantan, emulsion. Advantan emulsion - instructions for use Advantan emulsion instructions

1 g of the emulsion contains 1 mg (0.1%) methylprednisolone aceponate.

Release form:

Emulsion 20 g in an aluminum tube in a cardboard box.

The emulsion is white, opaque.

Pharmachologic effect:

Glucocorticosteroid (GCS) for topical application.

Indication for use:

Inflammatory skin diseases sensitive to topical GCS therapy:

atopic dermatitis, neurodermatitis, childhood eczema;
simple contact dermatitis;
allergic (contact) dermatitis;
true eczema;
seborrheic dermatitis / eczema;
microbial eczema;
photodermatitis, sunburn.

Method of administration and dosage:

For adults and children from 4 months, the drug is applied once a day with a thin layer on the affected skin.

The course of treatment with Advantan in the form of an emulsion is usually no more than 2 weeks.

The emulsion is applied to the skin in a thin layer, rubbing lightly. For sunburn, the emulsion is used 1-2 times a day. If skin dry excessively when using the emulsion, it is necessary to switch to the dosage form of Advantan with a higher fat content (ointment or fatty ointment).

Contraindications:

tuberculosis of the skin and skin manifestations of syphilis in the area of application of the drug;
viral skin lesions in the area of application of the drug (for example, when chickenpox, shingles);
rosacea, perioral dermatitis in the area of application of the drug;
skin manifestations of a reaction to vaccination;
childhood up to 4 months;
hypersensitivity to the components of the drug.

Special instructions:

In the presence of bacterial dermatoses and / or dermatomycosis, in addition to Advantan therapy, specific antibacterial or antifungal treatment should be carried out.

Avoid getting the drug in the eyes.

As with the use of systemic corticosteroids, with external use of GCS, glaucoma may develop (for example, after high doses or very long-term use, the use of occlusive dressings or application to the skin around the eyes).

Influence on the ability to drive vehicles and control mechanisms: not found.

Storage conditions:

The emulsion should be stored at a temperature not exceeding 25 ° C out of the reach of children. Shelf life is 3 years.

Note:

The drug is approved for use as a means of OTC.

Advantan Ointment is a glucocorticosteroid used only topically. It is a non-halogenated synthetic steroid, or synthetic hormone, that is, hormonal. Advantan cream is optimal for the effective suppression of skin inflammation or allergy symptoms, in case of proliferation. It optimally affects external symptoms (erythema, edema, lichenification), sensitivity (soreness, itching, irritation), significantly reducing them.

Usage. Ointments, creams and emulsions are used externally on skin surfaces. It is highly undesirable for medications to get into the eyes or inside the body.

Compound. Methylprednisolone aceponate and excipients.

Active substance. The most important agent of the drug is methylprednisolone aceponate - 0.001 g.

Excipients. Advantan ointment includes some other substances: paraffins, wax, emulsifier Dehimuls E, purified water. These ingredients are safe and neutral.

Pharmacological properties

When methylprednisolone aceponate is used as a medication, it has been noticed that little expressed external systemic actions in humans. It is observed that if the cream was applied many times to large areas of the skin (40-60%), or there was an occlusive dressing from above, a normal state is noted without any pathologies, no impaired adrenal function is noted (cortisol in the blood plasma is in a normal state, also in urine, the usual circadian rhythm melts).

It is observed that when using medicines by adults and children, for one or three months, there is no skin atrophy, deformation, stretching or acne-like rashes.

Pharmacinetics

Methylprednisolone aceponate tends to hydrate in the epidermis. The most important and most active metabolite is 6а-methylprednisolone-17-propionate, which has much higher affinity for glucocorticosteroid receptors in the skin. Skin "bioactivation" takes place.

The degree of percutaneous absorption depends on the condition of the epidermis, the form of treatment and on the methods used (whether or not there is an occlusive dressing).

It is observed that the increase in such absorption in people of different ages with atopic dermatitis and psoriasis is very small (2.5%), compared with healthy people (1.5%).

The formed active metabolite, by binding to intracellular glucocorticoid receptors inside cells, contributes to the formation of a number of biological processes. Thanks to this, macrocortin appears, which reduces inflammation by inhibiting the release of arachidonic acid. The main substance is usually excreted through the kidneys and is not accumulated in the body.

Indications for use

Treatment begins if there are some types of epidermal ailments, as well as susceptibility to therapy with topical glucocorticosteroids.

Apply a medication if manifestations are detected:

dermatitis atopic, simple,,;
various eczema (true, microbial, dyshidrotic);
sunburn, photodermatitis.

Contraindications

Medications are not used if there are signs:

syphilis symptoms;
herpes or defects from (subsequently viral diseases);
or, in places where the cream is applied;
skin reactions after vaccination;
susceptibility to certain substances in liniment;
ailments of a bacterial and fungal nature;
skin lesions in the form of open wounds.

It is not allowed to use honey for newborns up to 4 months.

Pregnancy and lactation

It is highly discouraged for pregnant women to use medication in the first trimester. Since they are hormonal, if they enter the bloodstream, a negative effect on the development of the fetus is possible. If there is a need to apply liniment for a pregnant woman or for a nursing mother, then it is necessary to discuss the options for therapy with a specialist, as far as necessary, and consider all possible. During such periods, it is not advisable to use the medication for a long time. A woman who is breastfeeding a baby is not allowed to apply the product to the breast.

Method of administration and dosage

The tool is used exclusively externally. The medicine should be used after the doctor's prescription. The cream is applied in thin balls to the areas of concern, once every 24 hours. It is used for no more than 3 months by adults and 1 month by children.

If it is observed under an acute course of the disease or it turns into a protracted form, in which there is no wetness, then it is required medical procedure with special ratios of fat and water. Liniment of the fatty composition helps to normalize the state of the epidermis, in addition to therapeutic properties, removes dryness, and gives it optimal moisture.

Side effects

Side effects are not observed, since the components generally tolerate everything normally. In extremely rare exceptions, some discomfort may occur, sometimes itching is felt, there may be erythema or vesicular rash.

If the drug is used for longer than the specified period or over a large area, then occasionally a certain reaction occurs, the skin may atrophy a little, a fine mesh appears due to dilated small capillaries, striped stretch marks, acneform rashes, systemic effects, after absorption of a corticosteroid. During the research, such reactions were absolutely not detected, provided that the medication was used correctly, and no longer than the prescribed line.

Very rarely, there is a reaction to the constituent substances of Advasan in the form of: folliculitis, hypertrichosis, perioral dermatitis, depigmentation, allergies.

Overdose

Investigating, the main active ingredient of the drug methylprednisolone aceponate, did not find the danger of acute intoxication when the cream was applied to large areas of the skin, if the conditions for absorption were normal, or if it was accidentally ingested.

If the local use of glucocorticosteroids takes a long time and often, then the manifestation of skin atrophy, its depletion, telangiectomy, stretching is possible. If there are such signs, then therapy must be discontinued.

Storage conditions

The best temperature for preserving preparations is considered to be a cool environment, no more than 25 C. Fatty ointments are also recommended to be stored in a cool environment, but a warmer environment up to 30 degrees is also allowed. Such medications are required to be kept in closed places away from babies.

Shelf life - can be stored - 3 years, no more, and oily liniment - no more than 5 years. It is forbidden to use the medication after the end of its service life.

A feature of Advantan is that it has the ability to instantly remove and not accumulate in the body its main substance. For a faster effect and a quicker result, in the treatment of dermatoses, a specific antimycotic or antibacterial medicine can be prescribed as an adjunct. It is carefully required to use the product in the area near the eyes, to exclude it from flowing there. Using external therapy with glucocorticosteroids in the eye area, there may be a risk of developing glaucoma. If pathology is noticed, then it is assumed long treatment... Use the product under occlusive dressings to clean the skin around the eyes.

Cream analogs and reviews

Advantan can be replaced by analogs:

Akriderm;
Beloderm;
Momat;
Monov;
Celestoderm-B;
Elocom.

Elokom is a popular analogue of Advantan, only it is based on mometosone furoate instead of methylprednisolone. A small amount of methylprednisolone enters the systemic circulation, so it is considered safer, especially for babies. Elok is allowed for children over two years old.

Advantan usually receives positive reviews, while analogues are inferior in quality.

Instructions for use for children of Advantan cream

Consider the instructions for using Advantan cream for children. If, in infants and children preschool age, irritation or inflammation appeared on certain parts of the epidermis, then liniment is usually prescribed, and not an emulsion.

Methylprednisolone is a synthetic glucocorticosteroid, that is, it is hormonal, therefore, especially for babies, careful use is required. Only with the strong allergic symptoms this remedy is recommended for infants from 4 months. Usually, the appointment of a topical glucocorticoid to a child by doctors is accompanied by a number of rules:

take into account the biorhythm of children (preferably in the morning);
take into account the individual characteristics of each child (features of manifestation, weight, height, age, how long to last, the state of the course of diseases, and others);
sometimes, it is necessary to adjust the concentration of the hormonal substance, stirring in different ratios with baby cream or petroleum jelly in proportions of 1:10 - for babies, 1: 7 - for crumbs up to 3 years old, 1: 4 - for children up to 5 years old , 1: 3 - for children under 10 years old, 1: 1 - for older children from 10 years old.
when the therapy is selected, other local or systemic treatments can be added on the advice of a doctor.

With diathesis and complex advanced allergies, Advantan also has a very good effect. For babies, the emulsion is rarely advised and is used with great care so as not to cause irritation. Since the agent is hormonal, it is not necessary to stop therapy abruptly, but slowly.

If the skin is in critical condition, it is possible to add other medications, after consulting a specialist. It is advisable to choose medications, preferably taking into account the degree of damage to the epidermis, and their susceptibility. If dry skin is noticed, then oily liniment is advised, if normal - take the usual one, if there is wetness - it is advised to take a cream. For sunburn and photodermatitis, they are treated with emulsions.

Advantan emulsion instructions for use

Advantan emulsion instructions for use will be considered below. The emulsion contains in 1 gram methylprednisolone aceponate - the most important active ingredient 1 mg, as well as other substances.

The emulsion is usually milky, opaque.

The emulsion has the property of suppressing various skin symptoms of inflammation, such as dermatitis and eczema, it is especially effective for sunburn and photodermatitis.

These medicines are constantly used by adult patients, they apply it a little on irritated places once every 24 hours. This course of therapy lasts approximately 14 days.

Instructions for medical use

medicinal product

Advantan ®

Tradename

Advantan ®

International non-proprietary name

Methylprednisolone aceponate

Dosage form

Emulsion 0.1%

Compound

1 g of emulsion contains

active substance- methylprednisolone aceponate 1.00 mg

Excipients: medium chain triglycerides, Softizan 378, polyoxyethylene-2-stearyl alcohol, polyoxyethylene-21-stearyl alcohol, benzyl alcohol, sodium edetate, glycerin 85%, purified water.

Description

White opaque emulsion

Pharmacotherapeutic group

Glucocorticosteroids for local treatment skin diseases.

Active glucocorticosteroids (Group III). Methylprednisolone aceponate.

ATX code D07AC14

Pharmacological properties

Pharmacokinetics

Methylprednisolone aceponate penetrates into the skin from the base dosage form... Its concentration decreases in the direction from the stratum corneum to the inner layers of the skin.

Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6α-methylprednisolone-17-propionate, which binds more strongly to corticoid receptors of the skin in comparison with the original drug, which indicates the presence of its "bioactivation" in the skin.

The degree and intensity of percutaneous absorption depends on many factors, such as the chemical structure of the active substance, the composition of the base of the dosage form, the concentration of the active substance in the base of the dosage form, the conditions during application of the drug (area of application, duration of exposure, on an open skin area or under an occlusive dressing) and the condition of the skin (type and severity of the disease, anatomical localization).

To study the transdermal absorption of methylprednisolone aceponate from the emulsion base, the skin condition was artificially changed.

Healthy skin was compared to skin with artificial inflammation (with ultraviolet erythema) and skin with artificial damage (with removed stratum corneum).

The intensity of absorption through the skin with artificial inflammation was very low (0.24% of the dose) and was slightly higher than through healthy skin(0.15% dose). Absorption through the skin with the removed stratum corneum was significantly higher (15%) than the dose.

In case of inflamed skin, in the case of treatment of the whole body with the Advantan emulsion, 20 g 2 times a day, the systemic load is about 2 μg of metiprednisolone aceponate per 1 kg of body weight per day.

After entering the systemic circulation, the product of the primary hydrolysis of 6α-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid, and thus inactivated. Metabolites of methylprednisolone aceponate (the main of which is 6α-methylprednisolone-17-propionate-21-glucuronide) are eliminated mainly by the kidneys with a half-life of about 16 hours. After intravenous administration excretion in urine and feces was completed within 7 days. Methylprednisolone aceponate and its metabolites are not accumulated in the body.

Pharmacodynamics

When applied externally, Advantan ® emulsion suppresses inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to a decrease in objective symptoms (erythema, edema, infiltration) and subjective sensations (itching, burning, pain).

Methylprednisolone aceponate (especially its main metabolite, 6α-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors.

The steroid-receptor complex binds to specific regions of DNA, thus causing a series of biological effects.

In particular, the binding of the steroid-receptor complex to DNA leads to the induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators such as prostaglandins and leukotrienes.

The immunosuppressive effect of glucocorticoids can be explained by the inhibition of cytokine synthesis and the antimitotic effect, which is still insufficiently studied.

Inhibition by glucocorticoids of the synthesis of vasodilating prostaglandins or potentiation of the vasoconstrictor action of adrenaline ultimately lead to a vasoconstrictor effect.

Indications for use

Acute exogenous eczema (allergic contact dermatitis, toxic degenerative eczema, numular eczema (microbial eczema), dyshidrotic eczema)

Atopic dermatitis (neurodermatitis)

Seborrheic eczema

Gravitational eczema

Solar dermatitis (severe sunburn)

Eczema of unknown etiology

Advantan ® emulsion is indicated for the treatment of children from 4 months.

Method of administration and dosage

Advantan® emulsion is used for topical application. The drug is applied once a day with a thin layer on the affected skin and rubbed lightly.

As a rule, the duration of treatment with Advantan ® should not exceed 2 weeks.

If the skin is excessively dry when using the Advantan® emulsion, which depends on the individual characteristics of the skin, additional neutral therapy (oil-water emulsion or single-phase fatty ointment) is recommended as a means to soften the skin.

Pediatric patients

No dose adjustment is required when prescribing Advantan® emulsion to children aged 4 months and older, as well as adolescents.

Side effects

The most frequent were such adverse reactions, like a burning sensation at the site of application of the drug.

Often (> 1/100,<1/10)

Burning sensation at the site of application of the drug

Infrequently (> 1/1000,<1/100)

Pain, blistering, itching, pustules, erosion at the site of application

Eczema, flaking and cracked skin

As with other topical corticosteroids, the following local adverse reactions may occur:

- skin atrophy, dryness, erythema, striae, folliculitis at the site of application of the drug, hypertrichosis, telangiectasia, perioral dermatitis, skin discoloration, acne and / or allergic skin reactions to any of the components of the dosage form. Systemic effects of corticosteroids can be observed when applied topically due to drug absorption.

Contraindications

Tuberculous or syphilitic processes in the area of application of the drug

Viral diseases (eg, chickenpox, shingles) in the area of application

Rosacea, perioral dermatitis, ulcers, acne, atrophic skin diseases, post-vaccination skin reactions in the area of drug application

Hypersensitivity to the active substance or to any of the excipients of the drug

Drug interactions

Not installed

special instructions

In the presence of bacterial dermatoses and / or dermatomycosis, in addition to Advantan ® therapy, specific antibacterial or antimycotic treatment should be carried out.

When using the Advantan ® emulsion, care should be taken to avoid getting the drug in the eyes, deep open wounds and mucous membranes.

When using Advantan ® fatty ointment 0.1% in children on large surfaces (40-90% of the skin surface) in the absence of an occlusive dressing, there are no adrenal dysfunctions.

When Advantan ® ointment 0.1% was applied on 60% of the skin surface for 22 hours under an occlusive dressing, there was a suppression of plasma cortisol levels and an effect on the circadian rhythm in healthy adult volunteers.

Emulsion Advantan ® should not be applied under an occlusive dressing. Should have in mind that diapers (pampers) can create an occlusive effect. This is especially important since the Advantan emulsion ® not recommended for use in children under 4 months of age. As with the use of systemic corticosteroids,

glaucoma when using topical corticosteroids (for example, after high doses, or with extensive application of the drug for a long time, using occlusive dressings or applying the drug to the skin around the eyes).

Pregnancy and lactation

Pregnancy

There are no adequate data on the use of the drug during pregnancy.

In general, the use of topical preparations containing corticosteroids should be avoided during the first trimester of pregnancy. In particular, during pregnancy, you should avoid applying the drug to large areas of the skin, prolonged use or application under an occlusive dressing.

There are epidemiological data indicating a possible increased risk of developing palatal obstruction in newborns whose mothers received glucocorticoid treatment during the first trimester of pregnancy.

In case of a clinical indication for the treatment of Advantan ® emulsion during pregnancy, the potential risk and the expected benefit of treatment should be carefully weighed.

Lactation

It is not known whether methylprednisolone aceponate is excreted in breast milk as systemic corticosteroids, which are reported to be secreted in breast milk.

It is not known whether topical application of the Advantan® emulsion can result in sufficient systemic absorption of metiprednisolone aceponate to be detected in breast milk.

Therefore, care should be taken when prescribing the drug to lactating women.

In nursing mothers, the drug should not be applied to the mammary glands. Avoid applying the drug to large skin surfaces, prolonged use or applying under an occlusive dressing during lactation.

Application in pediatric practice

Advantan ® can be used in children from 4 months of age. The safety of Advantan® emulsion has not been studied in children under 4 months of age. There are no data on the use of the drug in children in this group.

Features of the effect of the drug on the ability to drive a car or potentially dangerous machinery.

Does not affect

Overdose

Release form and packaging

20 g of the drug in tubes, sealed with plastic
lids. 1 tube together with instructions for use in the state Russian language is put into a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Storage period

Do not use after the expiration date.

Conditions of dispensing from pharmacies

On prescription

Manufacturer

Bayer Healthcare Manufacturing S.r.l., Segrate, Italy

Marketing Authorization Holder

Bayer Pharma AG, Berlin, Germany

The address of the organization that accepts claims from consumers on the quality of the product (goods) on the territory of the Republic of Kazakhstan:

Bayer KAZ LLP

st. Timiryazeva, 42, business center "Expo-City", pav. 15

050057 Almaty, Republic of Kazakhstan,

Tel. +7 727 258 80 40, fax: +7 727 258 80 39, e-mail: [email protected]

Did you get sick leave for back pain?

How often do you experience back pain?

Can you handle pain without taking pain relievers?

Learn more to deal with back pain as quickly as possible

Topical glucocorticosteroid.

Active ingredients

Brand name

Release form

Emulsion

Compound

1 g of emulsion contains
Active ingredient: methylprednisolone aceponate 0.001 g.
Excipients: medium-chain triglycerides - 0.150 g, softizan 378 - 0.050 g, polyoxyethylene-2-stearyl alcohol - 0.040 g, polyoxyethylene-21-stearyl alcohol - 0.040 g, glycerol 85% - 0.030 g, disodium edetate - 0.010 g, benzyl - 0.0125 g, purified water - 0.6755 g.

Pharmacological effect

The active component of the drug Advantan - methylprednisolone aceponate - is a non-halogenated steroid.

Pharmacokinetics

Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6α-methylprednisolone-17-propionate, which has a significantly higher affinity for glucocorticosteroid receptors in the skin, which indicates the presence of its "bioactivation" in the skin.
The intensity of absorption through the skin with artificial inflammation is very low (0.27% of the dose), which is only slightly higher than through healthy skin (0.17%). In the case of whole body treatment (eg, sunburn), the systemic dose is about 4 mcg per kg of body weight per day, which excludes systemic effects.
After entering the systemic circulation, 6α-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and, thus, in the form of 6α-methylprednisolone-17-propionate glucuronide is inactivated.
Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a half-life of about 16 hours. Methylprednisolone aceponate and its metabolites are not accumulated in the body.

Indications

Inflammatory skin diseases sensitive to topical glucocorticosteroid therapy:
Atopic dermatitis, neurodermatitis, children's eczema,
Simple contact dermatitis
Allergic (contact) dermatitis,
True eczema
Seborrheic dermatitis / eczema
Microbial eczema
Photodermatitis, sunburn.

Contraindications

Tuberculous or syphilitic processes in the area of application of the drug,
Viral diseases (for example, chickenpox, shingles), in the area of application of the drug,
Rosacea, perioral dermatitis in the area of application of the drug,
Children's age up to 4 months,
Areas of skin with manifestations of a reaction to vaccination,
Hypersensitivity to the components of the drug.

Application during pregnancy and lactation

If it is necessary to use Advantan emulsion during pregnancy and lactation, the potential risk to the fetus and the expected benefit of treatment for the mother should be carefully weighed. During these periods, long-term use of the drug on extensive skin surfaces is not recommended.
Breastfeeding mothers should not apply the drug to their breasts.

Method of administration and dosage

Outwardly. Adults and children from 4 months of age. The drug is applied once a day (for the treatment of sunburns 1-2 times a day) with a thin layer on the affected skin, rubbing lightly.
Usually, the course of treatment should not exceed 2 weeks.
If the skin dries excessively when using the Advantan emulsion, it is necessary to switch to a dosage form with a higher fat content (Advantan ointment or Advantan oily ointment).

Side effects

The drug is usually well tolerated.
Very rarely (less than 0.01% of cases), local reactions can occur, such as itching, burning, erythema, and the formation of a vesicular rash. If the drug is used for more than 4 weeks and / or on an area of 10% or more of the body surface, the following reactions may occur: skin atrophy, telangiectasia, striae, acneform skin changes, systemic effects due to absorption of a corticosteroid. In clinical trials, none of the above side effects were observed when using the Advantan emulsion up to 12 weeks in adults and up to 4 weeks in children.
In rare cases (0.01% - 0.1%), folliculitis, hypertrichosis, perioral dermatitis, skin depigmentation, allergic reactions to one of the components of the drug can be observed.

Overdose

When studying the acute toxicity of methylprednisolone aceponate, there was no risk of acute intoxication with excessive single skin use (application of the drug over a large area under conditions favorable for absorption) or unintentional ingestion.
With excessively long and / or intensive use of glucocorticosteroids, skin atrophy (thinning of the skin, telangiectasia, striae) may develop.
If atrophy occurs, the drug must be canceled.

Interaction with other drugs

Not found.

special instructions

In the presence of bacterial complications and / or dermatomycosis, in addition to Advantan therapy, specific antibacterial and / or antimycotic treatment should be carried out.
Avoid getting the drug in the eyes.
As with the use of systemic glucocorticosteroids, glaucoma may develop after topical application of glucocorticosteroids (for example, with the use of large doses, or very long-term use of occlusive dressings or application to the skin around the eyes).

Shelf life after opening

Store the opened aluminum tube for 3 months. Do not use after the expiration date.