Triderm, cream, 15g

Composition

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of 1 g of cream contains:

betamethasone 0.5 mg,

clotrimazole 10 mg,

gentamicin 1 mg.

Auxiliary substances:

liquid paraffin,

white I vaseline,

cetostearyl alcohol,

propylene glycol,

cetomacrogol-1000.

gasoline alcohol,

J sodium dibasic phosphate dihydrate,

phosphoric acid,

sodium hydroxide (to establish the required pH value),

purified water (q. s. ad 1000 mg).

Pharmacological action

Pharmacological group:

glucocorticosteroid+antibiotic-aminoglycoside+ antifungal agent.

Pharmacological action:

Triderm is a combined drug. Triderm ® ointment and cream combine 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 (inhibits the synthesis of ergosterol in the fungal cell membrane). 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 topical treatment for primary and secondary bacterial skin infections. Active against gram – negative microorganisms: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; gram-positive microorganisms: Streptococcus spp. (sensitive strains of alpha-and beta-hemolytic streptococcus group A), Staphylococcus aureus (coagulase-positive, coagulase-negative and some penicillinase-producing strains).

Indications

– the reduction of the inflammatory manifestations of dermatoses complicated by primary and secondary infection (simple and allergic dermatitis, atopic dermatitis, diffuse neurodermatitis, atopic dermatitis limited);

– athlete’s foot;

– pityriasis versicolor;

– simple chronic lichen;

– ringworm (including inguinal and large folds of the skin) caused by drug-sensitive pathogens: dermatofitia, candidiasis; colorful lichen.

Use during pregnancy and lactation

The use of TRIDERM during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

It is not known whether the components of the drug are excreted in breast milk.

Therefore, when prescribing TRIDERM during lactation, the issue of stopping breastfeeding should be resolved.

Contraindications

-hypersensitivity to any of the components of the drug Triderm;

– skin tuberculosis;

– skin manifestations of syphilis;

– chickenpox;

– herpes simplex;

– skin post-vaccination reactions;

– age up to 2 years.

Side effects

Local reactions: burning sensation, erythema, exudation, pigmentation disorder, itching.

Side effects caused by betamethasone: burning sensation, itching, irritation and dryness of the skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, sweating.

Side effects caused by clotrimazole: erythema, peeling, local edema, pruritus, urticaria, maceration of the skin, paresthesia.

Adverse reactions caused by gentamicin: hyperemia, pruritus.

How to take, course of use and dosage

The cream is used in the treatment of acute wetting skin lesions – in processes with wetting and severe inflammation.

TRIDERM cream should be applied 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 should be used regularly.

The duration of therapy depends on the size and location of the lesion, as well as the patient’s reaction. If clinical improvement does not occur after 3-4 weeks of treatment, this may be a reason to clarify the diagnosis.

Overdose

With prolonged use of high-dose glucocorticosteroids, symptoms of hypercorticism may develop.

The use of clotrimazole under an occlusive dressing for 6 hours did not lead to the development of symptoms of overdose.

Special instructions

It can not 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 with the development of irritation, sensitization or superinfection with the use of Triderm, treatment should be interrupted and appropriate therapy should be prescribed. Cross-allergic reactions with aminoglycoside antibiotics were observed.

Any side effects that occur with the use of systemic glucocorticosteroids, including suppression of the adrenal cortex, may also occur with topical use of glucocorticosteroids, especially in children. Systemic absorption of glucocorticosteroids or gentamicin with topical application will be higher if the treatment is carried out on large body surfaces or when using occlusive dressings.

Avoid applying gentamicin to open wounds or skin lesions. Appropriate precautions should be taken in such cases, especially when treating children.

Discontinuation of the drug after prolonged use is recommended to be carried out gradually.

Use in pediatrics: children are prescribed from 2 years of age only for strict indications and under medical supervision, because it is possible to develop systemic side effects associated with betamethasone. When using Triderm, as well as many other topical glucocorticosteroids on extensive surfaces and/or with an occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system, there may be a decrease in the excretion of growth hormone, as well as an increase in intracranial pressure.

Form of production

Cream for external use.

Storage conditions

Store at a temperature of +2 °C to +30 °C.

Shelf

life is 3 years.

Active ingredient

Betamethasone, Gentamicin, Clotrimazole

Dosage form

cream