Expiration date: 04/2025
Clinico-pharmacological group
(A drug with antibacterial, antifungal and anti-inflammatory action for topical use)
Release form, composition and packaging
1g contains:
betamethasone dipropionate mcg 643,
that corresponds to the contents of betamethasone 500 mcg
clotrimazole 10 mg
gentamicin (sulphate) 1 mg (1000 ME)
Cream for external use white or almost white, homogeneous, soft consistency that does not contain visible particles.
Excipients: petroleum jelly - 150 mg propylene glycol 100 mg, cetostearyl alcohol 72 mg, liquid paraffin 60 mg, macrogol cetostearyl - 22.5 mg, benzyl alcohol - 10 mg, sodium dihydrogen phosphate dihydrate - 2.995 ppm, phosphoric acid - 30 mcg, sodium hydroxide or phosphoric acid to establish the pH, purified water - q.s. up to 1 year
15 g - tubes aluminum (1) - packs of cardboard.
30 g - tubes aluminum (1) - packs of cardboard.
Pharmacological action
Combined preparation for external use.Triderm cream combines the anti-inflammatory, pruritic, anti-allergic and antiexudative effect of corticosteroids betamethasone dipropionate with the antifungal activity of clotrimazole and the wide antibacterial activity of gentamicin sulfate.Clotrimazole has antifungal activity by disrupting 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 furtur (Pityrosporum obiculare).Gentamicin is a broad-spectrum antibiotic of the aminoglycoside. Acts bactericidal and provides highly effective local treatment of primary and secondary bacterial skin infections. Active against gram-negative bacteria: Pseudomonas aeruginosa, Enterobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae, gram-positive bacteria: Staphylococcus aureus (coagulase-positive, coagulase-negative and some strains producing penicillinase).
Pharmacokinetics
Data on the pharmacokinetics of the drug Triderm is not available.
Dosage:
Triderm cream should be applied thinly to the whole affected surface of the skin and surrounding tissue 2 times/day - morning and night. To ensure the effectiveness of the treatment cream Triggermenuitem to apply regularly. The duration of therapy depends on the size and location of lesion and patient response.If clinical improvement does not occur after 3-4 weeks of treatment, this may be a reason for further diagnosis.
Overdose
Symptoms: long-term use of local corticosteroids in high doses may suppress the adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's symptom.
An overdose of clotrimazole with local application does not lead to the appearance of any symptoms. With a single overdose of gentamicin appearance of any symptoms is also not expected.Long-term treatment with gentamicin at high doses can lead to the growth of insensitive flora.Treatment: symptomatic therapy. Acute symptoms of hypercortisolism are usually reversible. If necessary, a correction of electrolyte imbalance. In the case of chronic corticosteroids of toxicity it is recommended that gradual withdrawal of corticosteroids.
Drug interactions
Drug interactions drug Triderm is not described.
Pregnancy and lactation
The use of the drug Triderm in pregnancy is possible only in the case when the expected benefit to the mother outweighs the potential risk to the fetus. Pregnant women should not use the drug on large areas of skin or for a long time.Unknown are the components of the drug with breast milk. Therefore, the purpose of the drug Triderm in the lactation period should solve the issue of termination of breastfeeding.
Side effects
Local reactions: very rarely - burning sensation, erythema, exudation, pigmentation disorders, itching.Adverse reactions encountered in the application of local corticosteroids (especially when using occlusive dressings): burning, itching, dryness, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, the development of secondary infection, skin atrophy, striae, miliaria.Adverse reactions caused by clotrimazole: erythema, tingling sensation, appearance of blisters, peeling, local edema, itching, hives, skin irritation.Adverse reactions caused by gentamicin: transient skin irritation (erythema, pruritus), usually does not require discontinuation of treatment.
Terms and conditions storage
The drug should be stored out of reach of children at temperature not exceeding 25°C. shelf Life - 3 years.
Testimony
Dermatoses complicated by infections caused by sensitive to the drug pathogens, or suspected of such infection, including:— simple and allergic dermatitis, atopic dermatitis (including atopic dermatitis), less atopic dermatitis, eczema, dermatomycosis (tinea, candidiasis, pityriasis versicolor), especially in the localization in the groin and large skin folds.Simple chronic zoster (limited neurodermatitis).
Contraindications
— tuberculosis skin, skin manifestations of syphilis, chicken pox, simple herpes, skin post-vaccination reactions— children under 2 years of age,— hypersensitivity to components of drug.With caution the drug should be used during pregnancy (especially in I trimester), children older than 2 years, for long-term treatment on large areas of skin or in violation of the integrity of the skin, when using occlusive dressings (especially in children).
Special instructions
Cream Triderm is not intended for use in ophthalmology.Prolonged local use of antibiotics can sometimes lead to an increase in resistant microflora. In this case, as well as with the development of irritation, sensitization or superinfection on the background of treatment with Triderm cream, treatment should be discontinued and assign appropriate therapy. Observed allergic cross-reactions with aminoglycoside antibiotics.Any side effects encountered in the use of systemic corticosteroids, including the inhibition of the function of the adrenal cortex, can be observed and the local application of corticosteroids, especially in children.Systemic absorption of corticosteroids or gentamicin in the local application will be higher if the treatment will be carried out on large areas of skin or when using occlusive dressings, especially with prolonged treatment or in violation of the integrity of the skin. It is necessary to avoid applying the powder on open wounds or damaged skin. Otherwise, it may cause side effects characteristic of gentamicin when administered systemically. Please follow the specific precautions in such cases, especially when treating children.Prolonged use of the drug its abolition is recommended gradually.Use in pediatrician the drug is prescribed 2 years and only on the strict condition and under medical control, because the evolution of systemic side effects associated with betamethasone, which can develop more frequently than in adult patients. Such side effects include: suppression function of the hypothalamic-gipofize-adrenal axis, Cushing's syndrome, growth retardation, slowing of body weight gain, increased intracranial pressure, manifested by bulging fontanelles, headaches, bilateral edema of the optic nerve.
Conditions of supply of pharmacies
The drug is approved for use as non-prescription medicines..
