Triderm - instructions for use, doses, side effects, contraindications

active substances: betamethasone dipropionate 0.643 mg (equivalent to 0.5 mg betamethasone), clotrimazole 10.0 mg, gentamicin sulfate in the equivalent of 1.0 mg (1000 IU) of gentamicin base;

Excipients: paraffin liquid 50.0 mg, paraffin soft white q.s. up to 1.0 g.

Description:

Homogeneous, translucent ointment from white to light yellow color, soft consistency, not containing extraneous inclusions.

Pharmacotherapeutic group:glucocorticosteroid for topical use + antibiotic-aminoglycoside + antifungal agent

ATX: & nbsp

S.01.C.A.05 Betamethasone in combination with antimicrobials

Pharmacodynamics:

Combination drug for external use.

Ointment TRIDERM ® combines anti-inflammatory, antipruritic, anti-allergic and antiexudative effect of glucocorticosteroid (GCS) betamethasone dipropionate from antifungal activity of clotrimazole and broad antibacterial action of gentamicin sulfate.

Clotrimazole has an antifungal effect due to a violation of the synthesis of ergosterol, which is an integral part of the cell membrane of fungi. Active with respect to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida albicans, Malassezia furfur (Pityrosporum obiculare).

Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group. It is 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).

Indications:Dermatoses complicated by infections caused by drug-susceptible pathogens, or suspected of such infections, including simple and allergic dermatitis, atopic dermatitis (including diffuse neurodermatitis), limited neurodermatitis, eczema, dermatomycosis (dermatophytosis, candidiasis, multicolored lichen), 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, cutaneous manifestations of syphilis, chickenpox, herpes simplex, skin post-vaccination reactions, open wounds, children's age (up to 2 years).

Carefully:

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

Pregnancy and lactation:

The use of TRIDERMA® during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

It is not known whether the components of the drug are excreted in breast milk. Therefore, when appointing TRIDERMA® during lactation, the question of stopping breastfeeding should be resolved.

Dosing and Administration:

Ointment Triderm® should be applied a thin layer on the entire affected surface of the skin and surrounding tissue twice a day - in the morning and at night. To ensure the effectiveness of treatment, Tridentum ointment® 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 specifying the diagnosis.

Side effects:

Very rarely with Triderma® are noted: burning sensation, erythema, exudation, pigmentation disorder and itching.

Adverse reactions that occur when applying local GCS (Particularly when using occlusive dressings): burning sensation, itching, dryness, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae, sudamen.

Adverse reactions due to clotrimazole: erythema, tingling sensation, the appearance of blisters, peeling, local edema, itching, hives, skin irritation.

Adverse reactions due to gentamicin: transient skin irritation (erythema, pruritus), usually not requiring discontinuation of treatment.

Overdose:

Symptoms: with prolonged use of local SCS in high doses, it is possible to suppress adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing's syndrome.

Overdose of clotrimazole with its local application does not lead to the appearance of any symptoms.

With a single overdose of gentamicin, any symptoms are also not expected.

Long-term treatment with gentamicin in elevated doses can lead to an increase in insensitive flora.

Treatment: symptomatic. Acute symptoms of hypercorticoidism are usually reversible. If necessary, correct the electrolyte imbalance. In the case of chronic GCS toxicity, the gradual elimination of GCS is recommended.

Interaction:No interaction of the drug Triderm® cream with other drugs has been reported.

Special instructions:

Ointment 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 in the background of treatment with Tridentum ointment®, treatment should be discontinued and appropriate therapy should be prescribed. There were cross-allergic reactions with aminoglycoside antibiotics.

Any side effects that occur in the use of systemic SCS, including oppression of adrenal cortex function, can be noted even with local application of GCS, especially in children.

Systemic absorption of GCS or gentamicin for topical application will be higher if treatment is performed on large areas of the skin or with the use of occlusive dressings, especially with prolonged treatment or in violation of the integrity of the skin. It is necessary to avoid applying gentamicin to open wounds and damaged skin. Otherwise, there may be side effects, characteristic of gentamicin in its systemic application. Appropriate precautions should be taken in such cases, especially when treating children.

With prolonged use of the drug, it is recommended to abolish it gradually.

Use in Pediatrics

For children, the drug is prescribed only on strict indications and under medical supervision. possible development of systemic side effects associated with betamethasone. When using Triderma®, as well as many other topical preparations based on GCS,on extensive surfaces and / or with an occlusive dressing, suppression of the function of the hypothalamic-pituitary-adrenal system is possible, a decrease in the excretion of growth hormone, and an increase in intracranial pressure can be observed.

Effect on the ability to drive transp. cf. and fur:There was no evidence of any influence of Triderm® on the ability to drive vehicles and work with mechanisms.

Form release / dosage:Ointment for external use, 0.5 mg / g + 1 mg / g + 10 mg / g.

Packaging:

For 15 g or 30 g of ointment in tubes of aluminum, treated with epoxy varnish and sealed with a membrane. The tube is additionally closed by a screwed polyethylene cap with a perforator for the membrane.

One tube with instructions for use in a cardboard pack.

Storage conditions:Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013503 / 01

Date of registration:20.12.2007

The owner of the registration certificate:BAYER, AO BAYER, AO Russia

Manufacturer: & nbsp

SCHERING-PLOUGH LABO, N.V. USA

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp20.11.2015

Illustrated instructions

Instructions

Triderm® (Triderm®)