Instructions for use Soderm cutaneous solution 0.1% bottle 30 ml
Composition
active ingredient: betamethasone;
1 g of solution contains 1.22 mg of betamethasone-17-valerate (equivalent to 1 mg of betamethasone);
Excipients: isopropyl alcohol, polysorbate 80, disodium edetate, diluted hydrochloric acid, purified water.
Dosage form
The solution is topical.
Main physicochemical properties: transparent colorless solution.
Pharmacotherapeutic group
Corticosteroids for use in dermatology. Active corticosteroids (group III).
ATX code D07A C01.
Pharmacological properties
Pharmacodynamics
Betamethasone valerate is a synthetic glucocorticosteroid for external use.
Betamethasone exhibits high glucocorticosteroid activity and only minimal mineralocorticoid effect.
Due to their anti-inflammatory, antipruritic, and vasoconstrictive effects, topical glucocorticosteroids such as betamethasone valerate are primarily used to treat dermatoses sensitive to corticosteroids.
Pharmacokinetics
After penetration into the skin, the pharmacokinetic profile of topical corticosteroids is similar to that of systemic corticosteroids.
Corticosteroids bind to plasma proteins to varying degrees. They are mainly metabolized in the liver and excreted in the urine.
Systemic absorption of topical corticosteroids is expected only under adverse conditions (prolonged treatment, occlusive dressing).
Some topical corticosteroids and their metabolites are excreted in the bile.
Indication
Treatment of scalp psoriasis and inflammatory, allergic or pruritic manifestations of non-infectious diseases of the scalp and body sensitive to potent glucocorticosteroid therapy (initial treatment of severe atopic eczema).
Contraindication
Soderm should not be used in primary viral (including post-vaccination reactions and chickenpox, herpes simplex, shingles), fungal and bacterial (tuberculosis, skin syphilis) skin lesions, in rosacea, rosacea-like and perioral dermatitis, perianal and genital itching, as well as in individual hypersensitivity to betamethasone or other components of the drug. Do not use in children under 1 year of age. Do not allow the drug to get into the eyes or mucous membranes. Do not use in the first trimester of pregnancy. Do not use under occlusive dressings.
Interaction with other medicinal products and other types of interactions
Not described.
Application features
Do not apply the solution to erosive, weeping areas or to skin cracks (abrasions) and ulcers (pus formation).
Long-term use of the drug (more than 3-4 weeks) and high doses (application to more than 20% of the body surface) should be avoided. In such cases, betamethasone may be absorbed through the skin and cause hormonal imbalance in the body.
If possible, prolonged treatment with the drug should be avoided on the skin of the face, as it is particularly sensitive.
Use extreme caution when applying the product near the face.
When applying the product to the eye area, avoid contact of Soderm with the mucous membrane of the eyes. In general, application of the product to the eyelids should be avoided, as this may provoke glaucoma.
Corticosteroids with high potency should be used with careful and periodic monitoring on large areas of skin, as they may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis. If suppression develops, the drug should be discontinued, the frequency of application reduced, or the patient transferred to a less potent corticosteroid.
GH function is usually restored upon drug withdrawal. In rare cases, withdrawal symptoms may develop, requiring the addition of a systemic corticosteroid.
Treatment should be discontinued if irritation or hypersensitivity occurs.
In the presence of infection, antifungal or antibacterial agents should be prescribed accordingly. If the desired effect does not occur quickly, use should be discontinued until signs of infection have resolved.
Use during pregnancy or breastfeeding
During pregnancy, long-term topical treatment with Soderm should only be carried out on the recommendation of a doctor. The drug should not be used in the first trimester of pregnancy.
During pregnancy, topical corticosteroids should not be used on large areas or for long periods of time due to the possible systemic effects of the drug, as this may lead to disturbances in the regulation of the GHNS and fetal development and growth. When the drug is used late in pregnancy, adrenal atrophy may develop in newborns.
Betamethasone passes into breast milk. Indications for use of the drug during breastfeeding should be strictly defined. If the disease requires the use of the drug in a higher dosage or on large areas of skin (more than 20% of the body surface), breastfeeding should be discontinued.
During breastfeeding, Soderm should not be applied to the skin of the chest and mammary glands.
Ability to influence reaction speed when driving vehicles or other mechanisms
Usually, the drug does not affect the patient's reaction speed when driving or working with other mechanisms.
Method of administration and doses
Soderm should always be used as directed by your doctor.
Unless otherwise prescribed, at the beginning of treatment, the affected areas of the skin should be moistened with Soderm solution in the morning and evening. As soon as the effect begins to appear, the number of daily applications can be reduced to 1 time per day (morning or evening), and later - to 3-4 times a week.
The course of treatment is determined by the doctor, usually the duration of treatment is from 2 to 4 weeks.
Soderm is available in bottles with a dispenser nozzle. Thus, it is recommended to apply the solution directly to the scalp without wetting the hair completely.
Children
There are no clinical data on the use of the drug in children, therefore it is undesirable to use it in patients of this age category.
Because children have a greater surface area to body weight ratio than adults, and therefore greater absorption of the drug, they are at greater risk of suppression of the GH function and the development of exogenous corticosteroid effects.
Overdose
Excessive or prolonged use of topical corticosteroids may cause suppression of pituitary-adrenal function, leading to secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing's syndrome. Acute symptoms of hypercorticism are usually reversible.
In case of overdose, appropriate symptomatic treatment is indicated. If necessary, correction of electrolyte balance is carried out. In case of chronic toxic effects, gradual withdrawal of the corticosteroid is recommended.
Adverse reactions
When assessing side effects, the following data on the frequency of occurrence are usually used as a basis:
very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000); not known (cannot be estimated from available data).
Skin and subcutaneous tissue disorders
Common: burning, itching, irritation, dry skin, erythema, folliculitis, hypertrichosis, acneiform eruption, flaky skin, focal skin exfoliation, skin induration, skin cracking, hypopigmentation, acne, rosacea-like and perioral dermatitis, allergic contact dermatitis.
Uncommon: skin maceration, skin atrophy, striae, perspiration, especially under occlusive dressing.
On the part of the endocrine system: suppression of the GHNS with the development of secondary adrenal insufficiency, symptoms of hypercorticism, Itsenko-Cushing's syndrome.
Infections and infestations
Uncommon: secondary infection, especially under occlusive dressing.
Other systems: hypersensitivity.
Other: tingling of the skin, feeling of warmth, telangiectasia.
When applying the drug to large surfaces, especially over a long period, it is necessary to bear in mind the possibility of developing systemic effects of the drug.
Any adverse events observed with systemic use of glucocorticosteroids, including suppression of the GHNS, may also occur with topical use of glucocorticosteroids.
If any side effects occur, you should consult a doctor.
Expiration date
3 years.
After opening the bottle – 3 months.
Storage conditions
Store the drug at a temperature not exceeding 25 °C in a place inaccessible to children.
Packaging
Solution of 15 ml or 30 ml, or 50 ml, or 100 ml in plastic bottles with a dropper and cap in a cardboard pack.
Vacation category
According to the recipe.
Producer
mibe GmbH Arcnaymittel.
Location of the manufacturer and its business address
Münchenerstrasse 15, 06796 Brena, Germany.
Applicant
Dermapharm AG, Germany.
Location of the applicant's representative
LLC "Mibe Ukraine" 01024, Kyiv, Chekistiv Lane, 2A, Ukraine.
