Ts-Derm ointment for external application approx. 1mg/1g in a tube 30g in a pack. No. 1 (betamethasone)

Compound

Betamethasone cream and ointment, instructions for use (Method and dosage)

The cream is used locally. The drug dosage regimen is developed individually.

The cream should be applied to the affected area of ​​the skin in a thin layer twice a day, gently rubbing. After signs of improvement appear, the frequency of use can be reduced to once a day. The duration of treatment is determined by the speed of disappearance of the inflammatory process, cleansing of the skin and cessation of itching. Also, the duration of the course of therapy depends on the severity and type of disease. Usually the course of treatment lasts 1-2 weeks. There should be a break of at least three weeks between repeated treatment cycles.

The course of therapy in children and patients with facial skin lesions is no more than 5 days.

Pharmacodynamics

Combined preparation for external use.

Triderm® ointment and cream combine the anti-inflammatory, antipruritic, antiallergic and antiexudative effect of the GCS betamethasone dipropionate with the antifungal activity of clotrimazole and the broad antibacterial effect of gentamicin sulfate.

Clotrimazole has an antifungal effect by disrupting the synthesis of ergosterol, which is an integral part of the cell membrane of fungi. Active against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida albicans, Malassezia furfur (Pityrosporum orbiculare).

Gentamicin sulfate, a broad-spectrum antibiotic from the aminoglycoside group, is bactericidal and provides highly effective local treatment of primary and secondary bacterial skin infections. Active against gram-negative microorganisms: Pseudomonas aeruginosa, Enterobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; gram-positive microorganisms: Staphylococcus aureus (coagulase-positive, coagulase-negative and some strains producing penicillinase).

Analogs

Level 4 ATC code matches:
Gistan-N

Sinalar

Avecourt

Mesoderm

Momederm

Betazon

Silkaren

Elokom

Flucinar

Sinaflan

Celestoderm

Cutivate

Advantan

Beloderm

Mometasone Furoate

Uniderm

Momat

Betamethasone analogs: Akriderm, Betazon, Beloderm Express, Betamethasone valerate, Betliben, Betamethasone dipropionate, Soderm, Celestoderm-V.

Indications for Triderm®

Dermatoses complicated by infections caused by pathogens sensitive to the drug, or when such infections are suspected, including:

simple and allergic dermatitis;

atopic dermatitis (including diffuse neurodermatitis);

limited neurodermatitis;

eczema;

dermatomycosis (dermatophytosis, candidiasis, lichen versicolor), especially when localized in the groin area and large folds of the skin;

simple chronic lichen (limited neurodermatitis).

Side effects

Very rarely, when using the drug Triderm®, the following are observed: burning sensation, erythema, exudation, pigmentation disorders and itching.

Caused by local corticosteroids (especially when using occlusive dressings): burning sensation, itching, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, development of secondary infection, skin atrophy, stretch marks, prickly heat.

Caused by clotrimazole: erythema, tingling sensation, blistering, peeling, local swelling, itching, urticaria, skin irritation.

Caused by gentamicin: transient skin irritation (erythema, itching), usually not requiring discontinuation of treatment.

Contraindications

This drug is prohibited for use in the presence of bacterial, fungal and viral skin lesions, skin symptoms of syphilis , tuberculosis , skin reactions after vaccination, perioral dermatitis , acne , perianal or genital itching, plaque psoriasis, rosacea, varicose veins . Also, the drug is not recommended for use in case of hypersensitivity to Betamethasone or other components of the drug.

Overdose

Symptoms: with long-term use of local corticosteroids in high doses, suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's syndrome, is possible. An overdose of clotrimazole when applied topically does not lead to the appearance of any symptoms. With a single overdose of gentamicin, the appearance of any symptoms is also not expected. Long-term treatment with gentamicin in high doses can lead to the growth of insensitive flora.

Treatment: symptomatic. Acute symptoms of hypercortisolism are usually reversible. If necessary, electrolyte imbalance is corrected. In case of chronic GCS toxicity, gradual withdrawal of GCS is recommended.

special instructions

Cannot be used in ophthalmic practice.

Prolonged topical use of antibiotics can sometimes lead to the growth of resistant microflora. In this case, as well as if irritation, sensitization or superinfection develops while using the drug Triderm®, treatment should be interrupted and appropriate therapy should be prescribed. Cross-allergic reactions with aminoglycoside antibiotics have been observed.

Any side effects that occur with the use of systemic corticosteroids, including suppression of the function of the adrenal cortex, can also be observed with local use of corticosteroids, especially in children.

Systemic absorption of GCS or gentamicin when applied topically will be higher if treatment is carried out over large surfaces of the body or when using occlusive dressings. Avoid applying gentamicin to open wounds or broken skin. Appropriate precautions should be taken in such cases, especially when treating children.

It is recommended to discontinue the drug after long-term use gradually.

Use in pediatrics

Children from 2 years of age are prescribed only according to strict indications and under medical supervision, because Systemic side effects associated with betamethasone may develop. When using the drug Triderm®, like many other topical corticosteroids on large surfaces and/or with an occlusive dressing, the function of the hypothalamic-pituitary-adrenal system may be suppressed, a decrease in the excretion of growth hormone, as well as an increase in ICP may be observed.

Impact on the ability to drive vehicles and operate machinery. No effect of Triderm® on the ability to drive vehicles or operate machinery has been identified.

Celestoderm-B ointment 0.1% 30g No. 1 (betamethasone)

Name

Celestoderm-v.

Release forms

Ointment.

INN

Betamethasone.

FTG

Glucocorticosteroid for local use.

Compound

1 g of ointment contains the active ingredient: betamethasone 1.0 mg (in the form of betamethasone 17-valerate 1.22 mg); excipients: white soft paraffin, mineral oil.

Description

A soft consistency white homogeneous ointment that does not contain foreign inclusions.

Pharmacotherapeutic group

Corticosteroids for use in dermatology. Corticosteroids, highly active (group III). ATC code D07AC01.

Pharmacological properties

Pharmacodynamics Betamethasone valerate is a synthetic glucocorticosteroid for topical use, has high glucocorticoid activity and minimal mineralocorticoid effect. Celestoderm-B® ointment has local anti-inflammatory, antipruritic, antiexudative and vasoconstrictive effects. Pharmacokinetics No studies have been conducted on the pharmacokinetics of Celestoderm-B®. After use of topical corticosteroids, systemic absorption is possible, especially when applied to broken skin or under occlusive dressings.

Indications for use

To reduce the inflammatory manifestations of dermatoses sensitive to glucocorticosteroid therapy, such as eczema (atopic, coin-shaped), contact dermatitis, seborrheic dermatitis, neurodermatitis, solar dermatitis, exfoliative dermatitis, radiation dermatitis, intertriginous dermatitis, psoriasis (with the exception of widespread psoriasis).

Contraindications

Untreated skin lesions caused by bacterial infections (for example, pyoderma, tuberculosis and syphilitic processes), as well as viral infections (for example, chicken pox, herpes simplex, herpes zoster, vulgar warts (condylomas), molluscum contagiosum); fungal skin infections, common psoriasis, parasitic infections, ulcerative skin lesions, wounds. The presence of adverse reactions after the use of corticosteroids (for example, perioral dermatitis, stretch marks). Ichthyosis, juvenile plantar dermatosis, acne vulgaris, rosacea, increased permeability of the walls of skin blood vessels, skin atrophy, anogenital itching. Celestoderm-B® is contraindicated in patients with hypersensitivity to the active substance or any other component of the drug.

Precautionary measures

If skin irritation occurs or signs of hypersensitivity appear in connection with the use of Celestoderma-B®, treatment must be stopped and adequate therapy must be selected for the patient. If infection is present, antifungal or antibacterial agents should be prescribed, respectively. If the desired effect does not occur quickly, the use of corticosteroids should be stopped until signs of infection are eliminated. Topical corticosteroids should be used with extreme caution in patients with psoriasis due to the potential for disease relapse, development of tolerance, risk of generalization of pustular psoriasis, and development of local or systemic toxicity due to impaired skin barrier function, as has been reported in several cases. Patients with psoriasis should be closely monitored if topical corticosteroids are used. Long-term use of potent corticosteroids can lead to the development of atrophic changes, especially on the face and other sensitive areas of the skin. This circumstance should be taken into account when treating diseases such as psoriasis and severe eczema. As with all potent glucocorticoid-based medications, Celestoderm-B® should be avoided for long periods of time, over large areas of skin, and on the face and skin folds. Avoid contact of the drug with wounds and mucous membranes. Celestoderm-B® should not be used in ophthalmology or applied to the eyelids due to the risk of developing glaucoma or subcapsular cataracts. Glucocorticoids may change the appearance of some skin lesions, making diagnosis difficult. Any side effects that occur with systemic use of glucocorticoids, including suppression of the adrenal cortex, can also occur with their topical use. Systemic absorption of topical corticosteroids is increased when used over a long period of time, when treating a large area of ​​the body, or when used under occlusive dressings. Due to the content of white soft paraffin in the composition, the tensile strength and, therefore, the safety of using latex condoms may be reduced, this should be taken into account when using the ointment in the genital or anal area. When using systemic and local corticosteroids (including intranasal, inhaled and intraocular administration), visual disturbances may occur. If symptoms such as blurred vision or other visual disturbances occur, the patient should be evaluated by an ophthalmologist to evaluate possible causes of the visual disturbance, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy, which has been reported following the use of corticosteroids systemic and local action.

Children

There are no clinical data on the use of the drug in children, so it is not advisable to use it in patients of this age category. Since the ratio of surface area to body weight is greater in children than in adults, the absorption of the drug is higher. Children are at greater risk of developing systemic adverse effects and suppression of the hypothalamic-pituitary-adrenal axis when using topical corticosteroids.

Use during pregnancy or breastfeeding

Animal studies of betamethasone valerate have shown reproductive toxicity. Celestoderm-B® ointment is not recommended for use in the first trimester of pregnancy. Due to the fact that the safety of using local corticosteroids in pregnant women has not been established, the prescription of these drugs is possible only when the expected benefit to the expectant mother clearly outweighs the potential threat to the fetus. Drugs in this group should not be used in pregnant women in high doses or for a long time. During lactation, the drug should not be used for a long time or on large areas of the skin. During breastfeeding, the ointment should not be used on the skin of the mammary gland; contact of the child with the treated areas of the skin should be avoided. It is not clear to date whether systemic absorption from topical corticosteroids can lead to excretion into breast milk; therefore, when deciding whether to discontinue breastfeeding or discontinue use of the drug, the importance of the treatment provided to the mother must be taken into account.

The ability to influence the reaction rate when driving a vehicle or working with other mechanisms

As a rule, the drug does not affect the speed of reaction when driving vehicles or operating other mechanisms.

Directions for use and doses

Celestoderm-B® is applied in a thin layer to the affected areas of the skin 1-3 times a day, depending on the severity of the condition. In most cases, to achieve the effect, it is enough to apply 1-2 times a day. The frequency of application of the drug is determined according to the degree of damage. For mild lesions, the drug can be applied once a day; in case of more severe lesions, the frequency of application of the drug must be increased. Do not use under occlusive dressings, as the side effects of the drug may increase. Continuous use of the drug should not exceed 4 weeks. After achieving a therapeutic effect, you should reduce the frequency of use of the drug Celestoderm-B® or switch to a less active corticosteroid for topical use and continue maintenance therapy with gradual withdrawal of the drug. If the condition does not improve or worsens within 2-4 weeks of therapy, it is necessary to re-evaluate and reconsider treatment.

Overdose

Symptoms: Excessive or prolonged use of topical corticosteroids can lead to depression of pituitary-adrenal function, leading to secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's syndrome. Acute symptoms of hypercortisolism are usually reversible. Treatment: in case of overdose, appropriate symptomatic treatment is indicated. If necessary, electrolyte balance is corrected. In case of chronic toxicity, gradual withdrawal of the corticosteroid is recommended.

Side effect

Adverse reactions are presented according to the classification of organ systems and frequency of occurrence: very often (≥ 1/10), often (≥ 1/100 to

Interaction with other drugs and other types of interactions

No known interactions.

Best before date

3 years.

Storage conditions

Store out of the reach of children, at a temperature not exceeding 25°C.

Package

30 g of the drug in aluminum tubes with a membrane, with an internal varnish coating and a sealed protective ring, a screw cap made of high-density polyethylene with a pin for piercing the membrane. 1 tube along with instructions for use is placed in a cardboard pack.

Vacation category

On prescription.

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