Triderm ointment, 15 g

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).

Triderm ointment 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 ointment 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.

1 g of ointment contains:
active substances: betamethasone dipropionate - 0.643 mg (equivalent to 0.5 mg of betamethasone), clotrimazole - 10.0 mg, gentamicin sulfate - equivalent to 1.0 mg (1000 IU) of gentamicin base;
excipients: liquid paraffin - 50.0 mg, soft white paraffin - 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, open wounds, children (up to 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).

Trade name of the drug
TridermЃ.

International non-proprietary or group name
Betamethasone + Gentamicin + Clotrimazole.

Dosage form
Ointment for external use.

The composition of
1 g of the ointment contains:
active substances: betamethasone dipropionate - 0.643 mg (equivalent to 0.5 mg of betamethasone), clotrimazole - 10.0 mg, gentamicin sulfate - equivalent to 1.0 mg (1000 IU) of gentamicin base;
excipients: liquid paraffin - 50.0 mg, soft white paraffin - qs up to 1.0 g.

Description
Homogeneous translucent ointment from white to light yellow in color of soft consistency, free of foreign inclusions.

Pharmacotherapeutic group
Anti-inflammatory, antibacterial, antifungal agent.

ATX code: D07XC01

Pharmacological properties
Combined preparation for external use.
Triderm ointment combines the anti-inflammatory, antipruritic, antiallergic and antiexudative effect of the glucocorticosteroid (GCS) 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, Malassezia furtur (Pityrosporum obiculare).

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, Enterobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae; gram-positive bacteria: 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, tinea 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, open wounds, children (up to 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).

Use during pregnancy and lactation
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.

Method of administration and dosage

Triderm ointment 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 ointment 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 effect

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 gentamicin: 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, the onset of any symptoms is also not expected.
Long-term treatment with high doses of gentamicin 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 with other drugs has not been registered.

Special instructions
Triderm ointment 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 ointment, treatment should be discontinued and appropriate therapy should be 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.

Use in pediatrics
For children, the drug is prescribed only under strict indications and under medical supervision, because the development of systemic side effects associated with betamethasone is possible. When using Triderm, like many other drugs for topical use based on GCS, 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.

Influence on the ability to drive vehicles and work with mechanisms
No effect of the drug Triderm on the ability to drive vehicles and work with mechanisms has been identified.

Release form
Ointment for external use 0.5 mg / g + 1 mg / g + 10 mg / g. 15 g or 30 g of ointment in aluminum tubes, treated with epoxy varnish and closed with a membrane. The tube is additionally closed with a screw-on polyethylene cap with a membrane perforator. One tube together with instructions for use in a cardboard box.

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

Storage
conditions Store at a temperature not exceeding 25 ? —. Keep out of the reach of children.

Terms of leave
Without a prescription.