TRIDERM OINTMENT 15G

Trade name of the drug

Triderm

International non-proprietary or grouping name

Betamethasone + Gentamicin + Clotrimazole.

Dosage Form

Ointment for external use.

Composition

1 g ointment contains:

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

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

Description

Uniform translucent ointment from white to light yellow color of a soft consistence, not containing foreign inclusions.

Pharmacotherapeutic group

Anti-inflammatory, antibacterial, antifungal agent.

Pharmacological properties

Combined preparation for external use.

Ointment Triderm combines the anti-inflammatory, antipruritic, antiallergic and anti-exudative effect of glucocorticosteroid (GCS) betamethasone dipropionate with the antifungal activity of clotrimazole and the wide antibacterial action of gentamicin sulfate.

Clotrimazole has antifungal effect due to a violation of the 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 from the group of aminoglycosides.Bactericidal effect and provides highly effective local treatment of primary and secondary bacterial infections of the skin. 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 that are susceptible to the drug, or if such infections are suspected, including simple and allergic dermatitis, atopic dermatitis (including diffuse neurodermatitis), limited neurodermatitis, eczema, dermatomycosis (dermatophytosis, candidosis, lichen-colored), especially when localized in the groin area and large skin folds; simple chronic lichen (limited neurodermatitis).

Contraindications

Hypersensitivity to any of the components of the drug, skin tuberculosis, skin manifestations of syphilis, chicken pox, herpes simplex, skin post-vaccination reactions, open wounds, children's age (up to 2 years).

Carefully

Pregnancy (especially in the first trimester), child age (> 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

The use of Triderm during pregnancy is possible only in the case when the intended benefits to the mother outweigh the potential risk to the fetus.

It is not known whether the components of the drug are excreted in breast milk. Therefore, when prescribing a Triderm during lactation, it is necessary to decide on the termination of breastfeeding.

Dosage and administration

Ointment Triderm should be applied with a thin layer to the entire affected surface of the skin and the 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 response of the patient.

If clinical improvement does not occur after 3-4 weeks of treatment, this may serve as a reason to clarify the diagnosis.

Side effect

Very rarely, when using Triderm, a burning sensation, erythema, exudation, pigmentation disturbance and itching are noted.

Adverse reactions occurring when using local corticosteroids (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, strii, potnitsa.

Adverse reactions due to clotrimazole: erythema, tingling sensation, blistering, peeling, local edema, itching, urticaria, skin irritation.

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

Overdose

Symptoms: With prolonged use of local corticosteroids in high doses, adrenal function suppression is possible with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing syndrome.

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

With a single overdose of gentamicin, no symptoms are expected either.

Prolonged treatment with gentamicin in high doses can lead to the growth of insensitive flora.

Treatment: symptomatic. The acute symptoms of hypercorticism are usually reversible. If necessary, carry out the correction of electrolyte imbalance. In the case of chronic GCS toxicity, the gradual abolition of GCS is recommended.

Interaction with other drugs

No interaction of the drug Triderm with other drugs is not registered.

special instructions

Ointment Triderm is not intended for use in ophthalmology.

Prolonged local 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 the treatment with Triderm ointment, treatment should be stopped and appropriate therapy should be prescribed. Allergic cross-reactions with aminoglycoside antibiotics were observed.

Any side effects that occur with the use of systemic corticosteroids, including suppression of the function of the adrenal cortex, can also be observed in the local application of corticosteroids, especially in children.

Systemic absorption of GCS or gentamicin when applied topically will be higher if treatment is carried out on large areas of the skin or when using occlusive dressings, especially with prolonged treatment or in violation of the integrity of the skin. Gentamicin should be avoided on open wounds and damaged skin. Otherwise, there may be side effects characteristic of gentamicin in its systemic use. Appropriate precautions should be taken in such cases, especially when treating children.

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

Use in pediatrics

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

Influence on ability to drive vehicles and work with mechanisms

No effect of the drug Triderm on the ability to drive vehicles and work with mechanisms was detected.

Release form

Ointment for external use of 0.5 mg / g + 1 mg / g + 10 mg / g.15 g or 30 g 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 perforator for the membrane. On one tuba together with the application instruction in a cardboard pack.

Shelf life

2 years.

Do not use after expiration date.

Storage conditions

Store at a temperature not higher than 25 ° С.

Keep out of the reach of children.

Vacation conditions

Over the counter.