active substance: 1 g of oily ointment contains 1 mg MPA;
excipients: paraffin, liquid, paraffin, white, soft, microcrystalline wax, hydrogenated castor oil.
Oily ointment. White or yellowish transparent oily ointment.The
Bayer Healthcare Manufacturing S. R. L., Italy.
Via E Schering, 21 20090, Segrate, Milan, Italy.
Bayer HealthCare Manufacturing SRL, Italy.
Via E Schering, 21 20090, Segrate, Milano, Italy.The
Corticosteroids for use in dermatology.
ATC Code D07A C14.
Methyprednisolone aceponate (6a-MPA) is dehalogenation corticosteroids synthetic molecule, which is characterized by a high degree of dissociation in the implementation of its local and systemic action.
6a-methyl group has a potentiating effect and lipophilic ester groups provide better penetration through the skin.
the Local anti-inflammatory effect, confirmed by pharmacological and clinical pharmacological studies, is similar to the effect of corticosteroids of potent action. System action methyprednisolone MPA when the local application according to studies, expressed slightly.The
Active substance of the drug Advantanis rapidly absorbed through the skin, but absorption is weak (<1% of the dose within 24 hours in the intact skin without occlusion, 3% with occlusion). The
Atopic dermatitis (neurodermatitis, endogenous eczema) is the real (true) eczema, irritant contact dermatitis and allergic contact dermatitis Skin eczema, baby eczema, seborrheic dermatitis (and eczema), including in the scalp area of the head; numularia eczema, dermatitis of the scalp with an inflammatory nature, accompanied by itching.
· Tuberculosis and syphilitic processes in the field of application of the drug viral diseases (for example, varicella, shingles), rosacea, perioral dermatitis, ulcerative lesions of the skin, common acne, atrophic dermatitis, skin reactions after vaccination in the field of application of the drug.
in the treatment of a pathological process on a large area of the skin, the duration of therapy should be clearly defined by the doctor.
In bacterial infectious processes of the skin and/or in the case of fungal infections need extra special treatment with antibiotic and/or antifungal drugs.
When applying Advantanavoid contact with eyes and deep open wounds, on mucous membranes.
using MPA on 60% of the body surface under occlusive dressing for 22 hours in healthy adults there was a decrease in the level of cortisol in blood plasma and the impact on its daily rhythm. When applying Advantana large surface of the skin (40 - 90% of the skin surface) without the use of occlusion in children (in newborns, occlusive dressing can be performed by a diaper), there was no violation of the function of the adrenal cortex. Despite this, when applied to a large surface of the skin, the duration of treatment should be as short as possible.
the risk of side effects is significantly increased when applying GCS for topical use over large areas of the body or over a long period, especially under occlusive dressing.
As in the case of systemic application of corticosteroids, in case of their topical application may cause glaucoma (for example, after use at high doses or over a large surface for a long period, use of occlusive dressings, or applied to the skin around the eyes).
the administration of drugs intended for local use, over a long period may cause sensitization. In this case, it is necessary to stop therapy and carry out appropriate treatment.
Pregnant women or women who are breastfeeding should not take this medication without the need for and without the close supervision of a physician; should avoid prolonged use or use on a large surface of the body.
In the I trimester of pregnancy it is desirable to avoid the topical use of preparations containing corticosteroids. During pregnancy should be avoided treatment of large areas of the skin, prolonged use of the drug or its use with occlusive dressing.
Some epidemiological studies provide an opportunity to suspect an increased risk for palatoschisis in newborns whose mothers received treatment with corticosteroids during the I. trimester of pregnancy.
Palatoschisis very rare pathology. If we consider the possibility of teratogenic effect of systemic corticosteroids, their effect can be attributed to an increase of 1-2 cases per 1000 women who received this treatment during pregnancy.
currently, there is no reliable data regarding the use of the drug Advantanpregnant, however, a minimum risk should be expected, since the probability of systemic corticosteroids for topical use is very low.
pregnant women prescribing Advantan oily ointment should be carried out only after a thorough assessment of the benefit/risk ratio.
Studies in mice found that MPA does not penetrate into the milk. However, it is not known whether MPA penetrates into breast milk, since corticosteroids, which were administered systemically, were present in breast milk. It is unknown whether the local use of fat ointment Advantan lead to systemic absorption of MPA in an amount that can be found in human breast milk. Therefore, it is necessary to appoint caution fat ointment Advantan women during breastfeeding.
In the period of breast-feeding do not apply the drug on the mammary gland. Especially avoid prolonged use of the drug, its application to large skin areas or use with occlusive bandage.
there is no Information on the effect of MPA on fertility.
Ability to influence the reaction rate when driving motor transport or operating other mechanisms.is Not installed.The
there is no data on the safety of the use of fat ointment Advantan children up to 4 months.
when using Advantan oily ointment for the treatment of children aged 4 months there is no need for dose adjustment.
Duration of use for children in normal cases should not exceed 4 weeks.
dosage and administration.
Typically, the drug should be applied to the affected areas of the skin once a day with a thin layer, unless the doctor prescribed otherwise.
Formula ointment Advantan(1 g ointment Advantancontains 1 mg of MPA), which is an anhydrous basis and provides an occlusive effect, helps to maintain skin moisture, softening the compacted layer of the skin and facilitating the penetration of the active substance. Therefore, the ointment Advantanis particularly indicated for dry forms and chronic stages of the disease.
Duration of use normally should not exceed for adults
12 weeks, for children-4 weeks.
there is no data on the safety of the use of fat ointment Advantan children up to 4 months.
when using Advantan oily ointment for the treatment of children aged 4 months there is no need for dose adjustment.The
in cases of skin atrophoderma associated with overdose in the case of topical administration of the drug, treatment should be discontinued. Usually the symptoms regress within 10 to 14 days.
during clinical trials, the most common side effects of Advantan oily ointment were folliculitis and itching at the site of application.
the frequency of adverse reactions observed in clinical trials and are given in the table below are determined according to the Convention MedDRA side-effects frequency: very often (> 1/10); frequently (> 1/100, <1/10); infrequently (> 1/1000, <1/100); single (> 1/10000,);
<1/1000); rare (<1/10000); unknown (frequency cannot be estimated based on available data). Version 12.0 of MedDRA was used for coding.
Organs and systems
General disorders and reactions at the site of application
the Stinging and folliculitis at the site of application
Pustules, vesicles, itching, pain, erythema, papules at the site of application
on the part of the skin and subcutaneous tissue
cracked Skin, telangiectasia
As in the case of external use of other GCS, there may be side effects (frequency uncertain) such as thinning of the skin (skin atrophy), the appearance of striae, inflammation of the hair follicles (folliculitis) at the site of application, excessive hair growth (hypertrichosis), telangiectasia, perioral dermatitis , skin discoloration, bacterial cellulite, contact dermatitis and allergic skin reactions to any of the components of the drug.
in some cases, the systemic effect of corticosteroids is possible due to their absorption. In case of any adverse reactions should stop using the drug and be sure to see a doctor.
Interaction with other medicinal products and other forms of interaction. No data. In connection with the absorption of treatment of large areas of the skin or treatment for a long period can cause interaction similar to that observed in systemic therapy. However, so far none of these types of interaction has been registered. If you need the simultaneous use of any other drugs should consult with your doctor.The
5 years old.The
Store at a temperature not exceeding 30 ° C out of reach of children.The
Tubes of 5 g or 15 gThe
over the counter.
a Local anti-inflammatory to treat skin conditions that are not accompanied by open wounds and ulcers. The anhydrous form of Advantan. It relieves swelling, redness, itching and burning, easing the patient's condition and accelerating tissue recovery. Well tolerated by adults and children from 4 months. Not applicable for the treatment of viral infections and acne.
Advantan in the form of oily ointment is indicated for people with very dry skin in need of mitigation, as well as in the chronic form of the following diseases:
Fatty ointment has the most pronounced therapeutic effect. The drug is used in cases where the cream, emulsion or conventional ointment dry the skin too much.
Advantan should not be applied to nursing mothers on the breast area. During pregnancy, it is permissible to apply only with the permission of the attending physician.
apply a thin layer to the affected area of the body no more than once a day. The total duration of treatment — no more than 3 months for adults and 1 month for children. Need the advice of your doctor before using the ointment.