Description
Release form
Emulsion for external use 0.1%
Packing
20 g aluminum tube
Pharmacological action of
corticosteroids for external use, is a non-halogenated synthetic steroid. With external use, Advantan suppresses inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to a decrease in objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).
When using methylprednisolone aceponate externally, the systemic effect is minimally expressed in both humans and animals. After repeated application of Advantan to large surfaces (40-60% of the skin surface), as well as when applied under an occlusive dressing, there is no adrenal gland dysfunction: the level of cortisol in the blood plasma and its circadian rhythm remain within normal limits, the level of cortisol in the daily urine does not decrease going on.
In clinical trials with the use of Advantan in the form of an ointment, cream, oily ointment or emulsion for up to 12 weeks in adults and up to 4 weeks in children (including young children), no development of atrophy of the skin, telangiectasia, striae and acne-like rashes.
Methylprednisolone aceponate (especially its main metabolite, 6β-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to certain sections 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 an inflammatory mediator such as prostaglandins and leukotrienes.
Inhibition of GCS synthesis of vasodilating prostaglandins and potentiation of the vasoconstrictor action of adrenaline leads to a vasoconstrictor effect.
Indications
Emulsion
Inflammatory skin diseases that are sensitive to topical corticosteroids therapy:
– atopic dermatitis, neurodermatitis, childhood eczema
– simple contact dermatitis
– allergic (contact) dermatitis srdlkrd eczema
– photodermatitis, sunburn.
Contraindications
– skin tuberculosis and skin manifestations of syphilis in the area of ² ¹ ² ¹application of the drug
– viral skin lesions in the area of ² ¹ ² ¹application of the drug (for example, with chicken pox, shingles)
– rosacea, perioral dermatitis in the area of ² ¹ ² ¹application of the drug
– skin manifestations of the reaction to vaccination
– children up to 4 months
– hypersensitivity to the components of the drug.
Use during pregnancy and lactation
If you need to use the drug Advantan during pregnancy and lactation, you should carefully weigh the expected benefits of therapy for the mother and the potential risk to the fetus or infant.
In this category of patients, it is not recommended to use the drug for a long time on extensive skin surfaces.
Nursing mothers should not apply the drug to the mammary glands.
Special instructions
In the presence of bacterial dermatoses and / or dermatomycoses, in addition to Advantan therapy, specific antibacterial or antifungal treatment is necessary.
The emulsion should not be used under an occlusive dressing. It must be borne in mind that diapers (diapers) can create an occlusive effect.
Avoid contact with eyes.
As with systemic corticosteroids, topical corticosteroids may cause glaucoma (for example, after high doses or for very long periods, using occlusive dressings or applying to the skin around the eyes).
Influence on the ability to drive vehicles and operate machinery
Does not affect the ability to drive vehicles and operate machinery.
Composition
1 g of emulsion contains:
Active ingredient:
methylprednisolone aceponate 1 mg.
Excipients:
medium chain triglycerides – 150 mg,
softisan 378 – 50 mg,
polyoxyethylene-2-sterile alcohol – 40 mg,
polyoxyethylene-21-sterile alcohol – 40 mg,
glycerol 85%, glycerol 30%, glycerol 85% edetate – 10 mg,
benzyl alcohol – 12.5 mg,
purified water – 675.5 mg.
Dosage and Administration
Externally.
Adults and children from 4 months of age apply the drug 1 time / day with a thin layer on the affected skin.
The emulsion is applied to the skin with a thin layer, gently rubbing.
In case of sunburn, the emulsion is used 1-2 times / day. If the skin is excessively dry when using an emulsion, you must go to the dosage form of Advantan with a higher fat content (ointment or oily ointment).
Side effects
Typically, the drug is well tolerated.
Very rarely (in less than 0.01% of cases) local reactions such as itching, burning, erythema, and the formation of a vesicular rash can be observed.
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 corticosteroid absorption.
In clinical trials, none of the above side effects were observed with Advantan before 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.
Drug Interactions
Drug Interactions Advantan not described.
Overdose
In the study of the acute toxicity of methylprednisolone aceponate, no risk of acute intoxication was observed in the case of excessive single external use (application of the drug to a large area under conditions favorable for absorption).
Symptoms: Skin atrophy (thinning of the skin, telangiectasia, stretch marks) can develop with excessively long and / or intensive topical application of ACS.
Treatment: Withdrawal.
Storage Conditions
The product should be stored at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Shelf life
3 years.
Deystvuyushtee substance
methylprednisolone aceponate
Conditions for dispensing from pharmacies
Without a prescription
Dosage form
emulsion for external use
Prescribing
Appointment
adults, pregnant by a doctor, Children older than 4 months, nursing mothers on the doctor’s prescription
