Tetraderm cream, 15g

Dermatoses complicated by infections caused by pathogens sensitive to the drug, or if such infections are suspected, including simple and allergic dermatitis, atopic dermatitis (including diffuse neurodermatitis), limited neurodermatitis, eczema, dermatomycosis (dermatophytosis, candidiasis, tinea versicolor), especially when localized in the groin and large folds of the skin; simple chronic lichen (limited neurodermatitis).

Outwardly.
Apply in a thin layer to the entire affected skin surface and surrounding tissue twice a day - in the morning and at night. To ensure the effectiveness of treatment, TRIDERM cream must be used regularly. The duration of therapy depends on the size and location of the lesion, as well as the patient's response.
If clinical improvement does not occur after 3-4 weeks of treatment, this may serve as a reason for clarifying the diagnosis.

1 g of cream contains:
active substances - betamethasone dipropionate - 0.643 mg (equivalent to 0.5 mg of betamethasone), clotrimazole - 10 mg, gentamicin sulfate (equivalent to 1.0 mg (1000 ME) of gentamicin base);

auxiliary substances - petrolatum, propylene glycol, cetostearyl alcohol, liquid paraffin, macrogol cetostearate, benzyl alcohol, sodium dihydrogen phosphate dihydrate, phosphoric acid, phosphoric acid or sodium hydroxide (qs for pH adjustment), purified water (qs up to 1.0 g).

Hypersensitivity to any of the components of the drug, skin tuberculosis, skin manifestations of syphilis, chickenpox, herpes simplex, post-vaccination skin reactions, children (less than 2 years).

With caution
Pregnancy (especially in the first trimester), childhood (> 2 years), long-term treatment, use on large areas of the skin or in violation of the integrity of the skin, the use of occlusive dressings (especially in children).

The trade name of the drug is TRIDERMЃ.

International non-proprietary name:

Betamethasone + Gentamicin + Clotrimazole

The dosage form is a cream for external use.

Composition
1 g of cream contains:
active substances - betamethasone dipropionate - 0.643 mg (equivalent to 0.5 mg of betamethasone), clotrimazole - 10 mg, gentamicin sulfate (equivalent to 1.0 mg (1000 ME) of gentamicin base);

auxiliary substances - petrolatum, propylene glycol, cetostearyl alcohol, liquid paraffin, macrogol cetostearate, benzyl alcohol, sodium dihydrogen phosphate dihydrate, phosphoric acid, phosphoric acid or sodium hydroxide (qs for pH adjustment), purified water (qs up to 1.0 g).

Description
A homogeneous cream of soft consistency, white or almost white, without visible particles.

Pharmacotherapeutic group
Anti-inflammatory, antibacterial, antifungal agent.

ATX code - D07XC01.

Pharmacological properties
Combined preparation for external use.
TRIDERM cream combines the anti-inflammatory, antipruritic, anti-allergic and anti-exudative effects of 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 fungal cell membrane. Active against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida albicans, Pityrosporum orbiculare (Malassezia furtur).
Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group. Acts bactericidal and provides highly effective local treatment of primary and secondary bacterial skin infections. Active against gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae; gram-positive bacteria: Streptococcus spp. (susceptible strains of group A beta and alpha hemolytic streptococcus), Staphylococcus aureus (coagulase-positive, coagulase-negative and some strains producing penicillinase).

Indications for use
Dermatoses complicated by infections caused by pathogens sensitive to the drug, or if such infections are suspected, including simple and allergic dermatitis, atopic dermatitis (including diffuse neurodermatitis), limited neurodermatitis, eczema, dermatomycosis (dermatophytosis , candidiasis, versicolor versicolor), especially when localized in the groin and large folds of the skin; simple chronic lichen (limited neurodermatitis).

Contraindications
Hypersensitivity to any of the components of the drug, skin tuberculosis, skin manifestations of syphilis, chickenpox, herpes simplex, post-vaccination skin reactions, childhood (less than 2 years).

With caution
Pregnancy (especially in the first trimester), childhood (> 2 years), long-term treatment, use on large areas of the skin or in violation of the integrity of the skin, the use of occlusive dressings (especially in children).

Application during pregnancy and lactation
The use of TRIDERM during pregnancy is possible only when the intended benefit to the mother outweighs the potential risk to the fetus. Pregnant women should not use the drug on large areas of the skin or for a long period of time. It is not known whether the components of the drug are excreted in breast milk. Therefore, when prescribing TRIDERM during lactation, the question of stopping breastfeeding should be resolved.

Method of administration and dosage
Outwardly.
Apply in a thin layer to the entire affected skin surface and surrounding tissue twice a day - in the morning and at night. To ensure the effectiveness of treatment, TRIDERM cream must be applied regularly. The duration of therapy depends on the size and location of the lesion, as well as the patient's response.
If clinical improvement does not occur after 3-4 weeks of treatment, this may serve as a reason for clarifying the diagnosis.

Side effects
Very rarely, when using Triderm, there are: burning sensation, erythema, exudation, pigmentation disorders and itching.
Adverse reactions that occur when using local GCS (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, striae , prickly heat.
Adverse reactions due to clotrimazole: erythema, tingling sensation, blistering, peeling, local edema, itching, urticaria, skin irritation.
Adverse reactions due to heptamycin: transient skin irritation (erythema, pruritus), usually not requiring discontinuation of treatment.

Overdose
Symptoms: With long-term use of local GCS in high doses, it is possible to suppress the function of the adrenal glands with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's syndrome. An overdose of clotrimazole when applied topically does not lead to the appearance of any symptoms.
With a single overdose of gentamicin, no symptoms are expected either.
Long-term treatment with heptamycin in high doses can lead to the growth of insensitive flora.
Treatment: symptomatic. Acute symptoms of hypercortisolism are usually reversible. If necessary, the electrolyte imbalance is corrected. In the case of chronic GCS toxicity, a gradual abolition of GCS is recommended.

Interaction with other medicinal products.
Any interaction of the drug Triderm cream with other drugs has not been registered.

Special instructions
TRIDERM cream is not intended for use in ophthalmology.
Long-term topical use of antibiotics can sometimes lead to the growth of resistant microflora. In this case, as well as with the development of irritation, sensitization or superinfection during treatment with TRIDERM cream, treatment. should be discontinued and appropriate therapy prescribed. Cross-allergic reactions with aminoglycoside antibiotics have been observed.
Any side effects that occur with the use of systemic corticosteroids, including inhibition of the function of the adrenal cortex, can also be observed with local administration of corticosteroids, especially in children.
Systemic absorption of corticosteroids or gentamicin when applied topically will be higher if the treatment is carried out on large areas of the skin or when using occlusive dressings, especially with long-term treatment or in violation of the integrity of the skin. Avoid applying gentamicin to open wounds and damaged skin. Otherwise, there may be side effects characteristic of gentamicin when used systemically.
Appropriate precautions should be taken in such cases, especially when treating children.
With prolonged use of the drug, it is recommended to withdraw it gradually.
Application in pediatrics
For children, the drug is prescribed only on strict indications and under medical supervision. systemic side effects associated with the use of topical corticosteroids, they may develop more often than in adult patients. These side effects include: suppression of the function of the hypothalamic-pituitary-adrenal system; Cushing's syndrome; growth retardation; slowing down weight gain; increased intracranial pressure, manifested by bulging fontanelles, headache, bilateral edema of the optic nerve head.

Release form
Cream for external use; 15 g or 30 g of cream in aluminum tubes, coated with epoxy varnish and sealed with a membrane and a polyethylene screw cap; 1 tube each with instructions for use in a cardboard box.

Storage conditions
At a temperature not exceeding 25 oC.
Out of the reach of children.

Shelf life is
3 years.
Do not use after the expiration date.

Terms of leave
Without a prescription.