Тридерм®

General characteristics. Structure:

Active ingredients: 643 mkg of betamethasone of propionate (that corresponds to 500 mkg of betamethasone), 10 mg of Clotrimazolum, 1 mg (1000 ME) of gentamycin in the form of sulfate.

Excipients: vaseline, propylene glycol, cetostearyl alcohol, liquid paraffin, a macrogoal цетостеарат, benzyl alcohol, dihydrophosphate sodium a dihydrate, phosphoric acid, phosphoric acid or sodium hydroxide - before establishment рН, the water purified.

The combined drug for external use.

Pharmacological properties:

Pharmacodynamics. Triderm® cream combines antiinflammatory, antipruritic, antiallergic and anti-exudative effect of GKS of betamethasone of Dipropionas with antifungal activity of Clotrimazolum and broad antibacterial action of Gentamycini sulfas.

Clotrimazolum has antifungal effect due to disturbance of synthesis of the ergosterol which is a component of a cellular membrane of mushrooms. Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida albicans, Malassezia furtur (Pityrosporum obiculare) is active concerning Trichophyton rubrum.

Gentamycin is an antibiotic of a broad spectrum of activity from group of aminoglycosides. Works bakteritsidno and provides highly effective topical treatment of primary and consecutive bacterial infections of skin. It is active concerning gram-negative bacteria: Pseudomonas aeruginosa, Enterobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae; gram-positive bacteria: Staphylococcus aureus (a coagualase - positive, a coagualase - the negative and some strains producing a penicillinase).

Pharmacokinetics. Data on pharmacokinetics of the drug Triderm® are not provided.

Indications to use:

The dermatosis complicated by the infections caused by activators, sensitive to drug, or at suspicion of such infections including:

— simple and allergic dermatitis;

— atopic dermatitis (including diffusion neurodermatitis);

— limited neurodermatitis;

— eczema;

— dermatomycoses (a dermatofitiya, candidiasis, multi-colored deprive), especially at localization in inguinal area and large folds of skin.

Chronic deprive idle time (limited neurodermatitis).

Route of administration and doses:

Triderm® cream should be applied with a thin layer on all struck surface of skin and surrounding fabric of 2 times/days - in the morning and for the night. To apply Triderm®neobkhodimo cream to ensuring efficiency of treatment regularly. Duration of therapy depends on the size and localization of defeat, and also on reaction of the patient.

If clinical improvement does not occur after 3-4 weeks of treatment, it can be the cause for specification of the diagnosis.

Features of use:

Use at pregnancy and feeding by a breast. Use of the drug Triderm® at pregnancy is possible only in that case when the estimated advantage for mother surpasses potential risk for a fruit. At pregnant women it is not necessary to use drug on big sites of skin or for a long time.

It is unknown whether drug components with breast milk are allocated. Therefore at purpose of the drug Triderm® in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.

Use for children. To children drug is appointed from 2 years only according to strict indications and under medical control since development of the system side effects connected with betamethasone which can develop at them more often than at adult patients is possible. Treat such side effects: suppression of function of gipotalamo-gipofizo-adrenal system, Cushing's syndrome, a growth inhibition, delay of an increase of body weight, the increase in intracranial pressure which is shown protrusion of fontanels, a headache, bilateral hypostasis of an optic nerve.

Special instructions. Triderm® cream is not intended for use in ophthalmology.

Long topical administration of antibiotics can sometimes lead to growth of resistant microflora. In this case, and also at development of irritation, a sensitization or superinfection against the background of treatment by Triderm® cream, treatment it is necessary to stop and appoint the corresponding therapy. Cross allergic reactions with aminoglikozidny antibiotics were observed.

Any side effects which are found at use of system GKS including oppression of function of bark of adrenal glands, can be noted also at topical administration of GKS, especially at children.

System absorption of GKS or gentamycin at topical administration will be higher if treatment is carried out on big sites of skin or when using occlusive bandages, especially at prolonged treatment or at disturbance of integrity of integuments. It is necessary to avoid putting gentamycin on open wounds or on the injured skin. Otherwise emergence of the side effects characteristic of gentamycin at its system use is possible. It is necessary to observe the appropriate measures of precaution in such cases, especially at treatment of children.

At long use of drug its cancellation is recommended to be carried out gradually.

Use in pediatrics. To children drug is appointed from 2 years only according to strict indications and under medical control since development of the system side effects connected with betamethasone which can develop at them more often than at adult patients is possible. Treat such side effects: suppression of function of gipotalamo-gipofizo-adrenal system, Cushing's syndrome, a growth inhibition, delay of an increase of body weight, the increase in intracranial pressure which is shown protrusion of fontanels, a headache, bilateral hypostasis of an optic nerve.

Side effects:

Local reactions: very seldom - burning sensation, an erythema, exudation, pigmentation disturbance, an itch.

The side reactions which are found at use of local GKS (especially at use of occlusive bandages): burning sensation, itch, xeroderma, hypertrichosis, eels, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of skin, development of consecutive infection, atrophy of skin, striya, heat rash.

The side reactions caused by Clotrimazolum: erythema, feeling of a pricking, emergence of blisters, peeling, local hypostasis, itch, small tortoiseshell, irritation of skin.

The side reactions caused by gentamycin: the passing irritation of skin (an erythema, an itch) which is usually not demanding the treatment termination.

Interaction with other medicines:

Medicinal interaction of the drug Triderm® is not described.

Contraindications:

— tuberculosis cutis;

— skin displays of syphilis;

— chicken pox;

— herpes simplex;

— skin postvaccinal reactions;

— children's age up to 2 years;

— hypersensitivity to drug components.

With care it is necessary to use drug at pregnancy (especially in the I trimester), at children 2 years, for prolonged treatment, on big sites of skin are aged more senior or at disturbance of integrity of integuments, when using occlusive bandages (especially at children).

Overdose:

Symptoms: at prolonged use of local GKS in high doses suppression of function of adrenal glands with development of secondary adrenal insufficiency and symptoms of a hypercorticoidism, including Cushing's symptom is possible.

The overdose of Clotrimazolum at its topical administration does not lead to emergence of any symptoms. At single overdose of gentamycin of emergence of any symptoms it is also not expected.

Prolonged treatment by gentamycin in the raised doses can lead to growth of insensitive flora.

Treatment: performing symptomatic therapy. Acute symptoms of a hypercorticoidism are usually reversible. If necessary carry out correction of an electrolytic imbalance. In case of chronic GKS of toxicity gradual cancellation of GKS is recommended.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature not above 25 °C. A period of validity - 3 years.

Issue conditions:

Without recipe

Packaging:

15 g - tubas aluminum (1) - packs cardboard.
30 g - tubas aluminum (1) - packs cardboard.