Triderm

General characteristics. Structure:

Active agents - betamethasone Dipropionas - 0,643 mg (0.5 mg of betamethasone), Clotrimazolum - 10 mg, Gentamycini sulfas (in an equivalent of 1.0 mg (1000 ME) of gentamycin of the basis are equivalent).

Excipients - vaseline, propylene glycol, cetostearyl alcohol, liquid paraffin, a macrogoal цетостеарат, benzyl alcohol, sodium dihydrophosphate a dihydrate, phosphoric acid, phosphoric acid or sodium hydroxide (q.s. for establishment of pH), the water purified (q.s. to 1.0 g).

Pharmacological properties:

The combined drug for external use.
TRIDERM cream combines antiinflammatory, antipruritic, antiallergic and anti-exudative effect 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, Pityrosporum orbiculare (Malassezia furtur) 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, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae; gram-positive bacteria: Streptococcus spp. (sensitive strains of a beta and alpha and hemolitic streptococcus of group A), Staphylococcus aureus (a coagualase - positive, a coagualase - the negative and some strains producing a penicillinase).

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 (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:

Outwardly.
To apply with a thin layer on all struck surface of skin and surrounding fabric twice a day - in the morning and for the night. TRIDERM cream needs to be applied to ensuring efficiency of treatment regularly. Duration of therapy depends on the size and localization of defeat, and also, reactions 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:

TRIDERM cream is not intended for use in ophthalmology.
Long local use 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, in particular 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 and 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 only according to strict indications and under medical control since the system side effects connected using local corticosteroids at them can develop more often than at adult patients. Treat such side effects: suppression of function of gipotalamo-gipofizo-adrenal system; Cushing's syndrome; growth inhibition; delay of an increase of weight; the increase in intracranial pressure which is shown protrusion of fontanels, a headache, a bilateral papilledema.

Side effects:

Very seldom at Triderm's use are noted: burning sensation, erythema, exudation, disturbance of pigmentation and itch.
The side reactions which are found at use of local GKS (especially at use of occlusive bandages): burning sensation, itch, xeroderma, folliculitis, 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 geptamitsiny: the passing irritation of skin (an erythema, an itch) which is usually not demanding the treatment termination.

Interaction with other medicines:

Any interaction of drug Triderm cream with other medicines is not registered.

Contraindications:

Hypersensitivity to any of drug components, a tuberculosis cutis, skin displays of syphilis, chicken pox, a herpes simplex, skin postvaccinal reactions, children's age (less than 2 years).

With care. Pregnancy (especially in the I trimester), children's age (> 2 years), prolonged treatment, use on big sites of skin or at disturbance of integrity of integuments, use of occlusive bandages (especially at children).

Use during pregnancy and a lactation. Use of TRIDERMA during 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 during a long span. It is not known whether drug components with breast milk are allocated. Therefore at purpose of TRIDERMA in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.

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 syndrome 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 geptamitsiny in the raised doses can lead to growth of insensitive flora.
Treatment: symptomatic. 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:

At a temperature not above 25 °C. In the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

External use cream; on 15 g or 30 g of cream in tubas aluminum, covered with an epoxy varnish and corked by a membrane and a polyethylene screw cap; on 1 tuba together with the application instruction in a cardboard pack.