Triderm^® (Ointment, Cream) Instructions for Use

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Clotrimazole (Rec.INN)

Gentamicin (Rec.INN)

Betamethasone (Rec.INN)

Clinical-Pharmacological Group

A drug with antibacterial, antifungal, and anti-inflammatory action for external use

Pharmacotherapeutic Group

Anti-inflammatory, antibacterial, antifungal agent

Pharmacological Action

A combined drug for external use.

Triderm^® cream combines the anti-inflammatory, antipruritic, antiallergic, and anti-exudative effect of the glucocorticosteroid betamethasone dipropionate with the antifungal activity of clotrimazole and the broad antibacterial action of gentamicin sulfate.

Clotrimazole exerts an antifungal effect by disrupting the synthesis of ergosterol, which is a component of the fungal cell membrane. It is active against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida albicans, Malassezia furfur.

Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group. It acts bactericidally and provides highly effective local treatment of primary and secondary bacterial skin infections. It is 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 penicillinase-producing strains).

Pharmacokinetics

Data on the pharmacokinetics of Triderm^® are not provided.

Indications

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);
• Localized neurodermatitis;
• Eczema;
• Dermatomycoses (dermatophytosis, candidiasis, pityriasis versicolor), especially when localized in the groin area and large skin folds.

Lichen simplex chronicus (localized neurodermatitis).

ICD codes

Dosage Regimen

Ointment

The drug is intended for external use.

Triderm^® ointment should be applied in a thin layer to the entire affected skin surface and surrounding tissue 2 times/day – in the morning and at night. To ensure treatment effectiveness, Triderm^® 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 be a reason to clarify the diagnosis.

Cream

The drug is intended for external use.

Triderm^® cream should be applied in a thin layer to the entire affected skin surface and surrounding tissue 2 times/day – in the morning and at night. To ensure treatment effectiveness, 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 be a reason to clarify the diagnosis.

Adverse Reactions

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

Adverse reactions occurring with the use of topical glucocorticosteroids (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, miliaria, as well as systemic reactions (blurred vision).

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, itching), usually not requiring discontinuation of treatment.

If the side effects listed in the instructions occur, or they worsen, or any other side effects not listed in the instructions are noted, the patient should inform the doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Skin tuberculosis;
• Skin manifestations of syphilis;
• Chickenpox;
• Herpes simplex;
• Post-vaccination skin reactions;

• Children under 2 years of age.

Use with caution during pregnancy (especially in the first trimester); in children over 2 years of age; for long-term treatment; when applied to large areas of skin or when the integrity of the skin is impaired; when using occlusive dressings (especially in children).

Use in Pregnancy and Lactation

Use of Triderm^® cream during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. In pregnant women, Triderm^® cream should not be used on large areas of 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^® cream during lactation, the issue of discontinuing breastfeeding should be considered.

Pediatric Use

The drug is contraindicated in children under 2 years of age.

The drug is prescribed with caution to children from 2 years of age only for strict indications and under medical supervision.

Special Precautions

Triderm^® cream is not intended for use in ophthalmology. Patients using systemic glucocorticosteroids or topical glucocorticosteroids have reported visual disturbances. If a patient experiences blurred vision or other visual disturbances, they should consult an ophthalmologist to assess possible causes, which may include cataracts, glaucoma, serous chorioretinopathy.

Prolonged topical use of antibiotics can sometimes lead to the growth of resistant microflora. In this case, as well as if irritation, sensitization, or superinfection develops during the use of 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 glucocorticosteroids, including suppression of adrenal cortex function, can also be observed with the use of topical glucocorticosteroids, especially in children.

Systemic absorption of glucocorticosteroids or gentamicin during topical application will be higher if treatment is carried out on large areas of skin or when using occlusive dressings, especially during long-term treatment or when the integrity of the skin is impaired. It is necessary to avoid applying gentamicin to open wounds and damaged skin. Otherwise, side effects characteristic of systemic gentamicin may occur. Appropriate precautions should be taken in such cases, especially when treating children.

With long-term use of the drug, its withdrawal is recommended to be carried out gradually.

Use in pediatrics

Children are more susceptible to the risk of suppression of the hypothalamic-pituitary-adrenal system due to the use of topical glucocorticosteroids than adults, due to their larger body surface area to weight ratio and, accordingly, increased absorption of the drug. In children, this is determined by low plasma cortisol levels and lack of response to adrenocorticotropic hormone stimulation. The occurrence of Cushing’s syndrome, growth and development disorders, slow weight gain, increased intracranial pressure, manifested by bulging fontanelle, headaches, bilateral papilledema is possible. Long-term use of the drug in children should be carried out for strict indications and under medical supervision. Atrophic skin changes occur more often in children than in adults with topical use of glucocorticosteroids. The course of treatment should be limited to five days. Occlusive dressings should not be used.

Effect on the ability to drive vehicles and mechanisms

No effect of Triderm^® on the ability to drive vehicles and operate machinery has been identified.

Overdose

Symptoms

With long-term use of topical glucocorticosteroids in high doses, suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing’s syndrome, is possible.

Overdose of clotrimazole with its topical use does not lead to any symptoms.

No symptoms are expected with a single overdose of gentamicin. Long-term treatment with gentamicin in increased doses may lead to the growth of insensitive flora.

Treatment

Symptomatic therapy is carried out. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance is performed. In case of chronic glucocorticosteroid toxicity, gradual withdrawal of glucocorticosteroids is recommended.

Drug Interactions

No interaction of Triderm^® with other drugs has been registered.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

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

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.