Trimistin® [Miramistin, Triamcinolone]

Pharmacological properties

Trimistin-Darnitsa ointment is a combined preparation for topical application. active substances - triamcinolone acetonide and miramistin.

Triamcinolone - fluorinated GCS, has a pronounced anti-inflammatory, anti-allergic and antiexudative effect. Interacting with a specific protein receptor in target tissues, it regulates the expression of corticoid-dependent genes and affects protein synthesis. Reduces the formation, release and activity of inflammatory mediators (histamine, kinin, prostaglandins, lysosomal enzymes). Suppresses cell migration to the site of inflammation; reduces vasodilation and vascular permeability in the focus of inflammation. Stabilizes lysosomal enzymes of leukocyte membranes; inhibits antibody synthesis and disrupts antigen recognition. It inhibits the release of interleukin-1, interleukin-2, interferon gamma from lymphocytes and macrophages. It induces the formation of lipocortin, inhibits the release of inflammatory mediators by eosinophils and stabilizes mast cell membranes. All these effects are involved in suppressing the inflammatory response in tissues in response to mechanical, chemical, or immune damage.

Miramistin is a broad-spectrum antiseptic, has a bactericidal effect (hydrophobic interaction with the membranes of microorganisms leads to their destruction). Effective against gram-positive (mainly) and gram-negative microorganisms (including aerobes and anaerobes), spore-forming and spore-forming microflora in the form of monocultures and microbial associations (including hospital strains with antibiotic resistance). It has an antifungal effect against ascomycetes of the genus Aspergillus and the genus Penicillium, yeast fungi (Rhodotorula rubra, Torulopsis gabrata and others) and yeast-like (Candida albicans, Candida tropicalis, Candida krusei and others), dermatophytes (Trichophyton rubrum Trichophyton trbrophytophytum Trichophyton trbrophytophytum Trichophyton trichrophophyt Trichophyton Trichophytophytum Trichophyton Trichophytum Trichophytofrichophytum Trichophyton Trichofophytum Trichophyton Trichophyton Trichofophytum Trichophyton Trichophytophy schoenleinii, Trichophyton violaceum, Epidermophyton Kaufman-Wolf, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis and others), as well as other pathogenic fungi, for example Pityrosporum orbiculare (Malassezia furfur), in the form of monocultures and microbial microorganisms . Effectively prevents infection of wounds, activating regeneration processes.

Pharmacokinetics The special physico-chemical properties of the ointment base and high molecular weight polymers, which are also in the base, with sorption properties keep the active components of the ointment at the site of application and prevent their diffusion into the systemic circulation.

Indications

Inflammatory skin diseases, including those complicated by a bacterial and fungal infection: eczema, atopic dermatitis, contact dermatitis, neurodermatitis, parapsoriasis, pemphigus, progressive and exudative psoriasis, seborrheic dermatitis, dermatitis dühring, discoid lupus erythematosus, photodermatosis, lymphoma.

Application

For external use.

During exudation, before using the drug, the erosive surface is treated with solutions of boric acid 1%, hydrogen peroxide 3% or chlorhexidine bigluconate 0.05%. If necessary, the ointment is applied under a sterile gauze dressing.

Adults: a thin layer of ointment is applied 1-2 times a day on the affected area of ​​the skin (maximum dose - no more than 15 g of ointment per day) or applied under an occlusive dressing (maximum dose - 10 g of ointment per day). The doctor determines the duration of treatment individually.

Elderly patients: the drug should be used with caution and for a short period, it should be borne in mind that in this category of patients the skin is thinner.

Contraindications

Hypersensitivity to triamcinolone and miramistin or other components of the drug. tuberculosis of the skin, which is localized at the site of application of the ointment; viral skin lesions, especially with herpes simplex and chickenpox; parasitic infections (scabies); syphilitic skin lesions; common plaque psoriasis; skin reactions after vaccination; varicose veins, leg ulcers; perianal and genital itching; facial skin lesions (rosacea, acne vulgaris,perioral dermatitis); diaper rash caused by wet diapers; treatment for dry peeling of the skin and applying ointment to the breast immediately before breastfeeding. skin cancer.

Side effects

From the side of the organ of vision: cataract, posterior subcapsular cataract, exophthalmos, glaucoma, swelling of the optic nerve papilla, corneal ulcer, exophthalmos. the likelihood of developing cataracts is higher in children.

From the digestive system: gastric bleeding, gastrointestinal bleeding, gastrointestinal perforation, esophagitis, pancreatitis, peptic ulcer.

From the nervous system: mental disorders, convulsions, dizziness, headache, increased intracranial pressure, insomnia.

From the cardiovascular system: heart failure, hypertension.

From the immune system: hypersensitivity reactions.

On the part of the skin and subcutaneous tissue: hyperemia, burning sensation, irritation, dryness, hypersensitivity, thinning of the skin, folliculitis, hirsutism, acneform rashes, hypopigmentation, perioral dermatitis, erythema of the face and telangiectasia, increased sweating, striae formation, allergic contact , secondary infections, slowing of wound healing, increased swelling, itching and getting wet, skin atrophy, slowing down reactions in skin tests, contact eczema, steroid acne, purpura.

From the musculoskeletal system and connective tissue: growth retardation in children, steroid myopathy, osteoporosis, osteonecrosis, aseptic necrosis.

Infections and parasitic diseases: activation of latent infections, masking the course of infections, opportunistic infections.

Systemic manifestations: in individual patients with prolonged use on a large surface, systemic side effects may develop: suppression of adrenal cortex function, decreased carbohydrate tolerance, Itsenko-Cushings syndrome; negative nitrogen balance is possible due to increased protein breakdown.

On the part of water-electrolyte metabolism: inhibition of the function of the adrenal cortex (secondary insufficiency of the adrenal cortex), hypokalemic alkalosis, delay in the body of water and sodium, hypokalemia, hypertension.

Laboratory abnormalities: increased intraocular pressure, negative nitrogen balance, slowing down reactions in skin tests.

special instructions

The effect of the ointment is partially weakened when applied to surfaces with a high content of purulent-necrotic masses. therefore, it is better to apply the ointment to the skin after its treatment with a warm soapy solution or, if necessary, with antiseptic solutions.

During the application of the ointment, microorganisms located on the skin (primarily pyogenic microorganisms, sometimes blastomycetes) can penetrate through the loosened stratum corneum and cause various pyoderma, which are treated with washable disinfectants.

The drug is not used in ophthalmic practice. It is impossible to prevent the drug from getting into the eyes, and ointment should not be applied to the skin around the eyes, since it is possible to develop glaucoma, cataracts, fungal infections of the eyes and exacerbation of herpes infection.

If skin irritation or signs of hypersensitivity appear in connection with the use of the ointment, treatment should be discontinued and the patient should be given adequate therapy. It is not recommended to use ointments for occlusive dressings and prolonged use of the drug on the skin of the face, since it is possible to increase side effects. Ointment is not used to treat varicose ulcers.

In the case of prolonged use of the drug when using occlusive dressings and when applied to a large surface of the body, especially in children, systemic side effects from the endocrine system are possible.These adverse reactions develop extremely rarely, are reversible and disappear immediately after stopping the use of the drug. For such patients, during the period of application of the ointment, regular monitoring of the function of the hypothalamic-pituitary-adrenal system is necessary. When symptoms of inhibition of the function of the hypothalamic-pituitary-adrenal system appear, it is necessary to cancel the drug or increase the intervals between applications of the ointment.

The use of local steroids for the treatment of psoriasis in some cases can lead to a relapse of the disease, the development of tolerance, an increased risk of generalized pustular psoriasis and the development of local or systemic (reversible suppression of the hypothalamic-pituitary-adrenal system) toxicity due to reduced skin barrier function. Therefore, in the treatment of psoriasis with the drug, careful care of the patient is important.

Some parts of the body, such as axillary cavities, inguinal folds (where there is natural occlusion), are more at risk of stretch marks. Therefore, the use of the drug in these areas should be short-lived.

In the case of the development of fungal or bacterial superinfection of the skin, additional use of an antifungal or antibacterial agent is necessary.

The use of ointment on the scalp is not recommended.

Use during pregnancy and lactation. The use of ointments in the first trimester of pregnancy is contraindicated. The doctor decides on the use of the drug in the II and III trimester of pregnancy and breastfeeding individually in each case, carefully weighing the ratio of the expected effect of treatment for the mother and the potential risk to the fetus / child. Data confirming the safety of the drug during pregnancy in the II and III trimester is not enough.

The absorption of GCS into the circulatory system is accompanied by their penetration into breast milk, the effect on the adrenal cortex and the growth of the baby.

Applying an ointment to the skin of the breast immediately before breastfeeding is contraindicated.

Children. Since there is no sufficient experience with the use of ointment in children, it is not used in pediatric practice.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Typically, the drug does not affect the reaction rate when driving vehicles or working with other mechanisms. However, when driving vehicles or working with other mechanisms, special caution is recommended, given the possibility of developing undesirable reactions from the nervous system.

Interactions

The effect of the ointment is partially weakened when applied to a surface with a high content of purulent-necrotic masses. therefore, it is better to apply it to the skin after its treatment with a warm soapy solution or, if necessary, with antiseptic solutions.

Means containing anionic surfactants (soap solutions) inactivate the drug.

With the simultaneous use of miramistin with systemic or local antibiotics, a decrease in the resistance of microorganisms to the latter is observed.

Overdose

When applying the ointment to the vast surfaces of the affected skin, it is possible that the active components of the ointment can partially enter the systemic circulation in amounts that cannot cause acute poisoning.

However, depending on the amount of corticosteroids that enter the body, it is possible to develop both local and systemic adverse reactions. The systemic effect of miramistin manifests itself as the action of a cationic detergent and can prolong the bleeding time. In case of an overdose of the drug, treatment should not be abruptly stopped - this should be done gradually, reducing the dose of the drug.With the development of symptoms of adrenocortical insufficiency, intravenous administration of hydrocortisone may be required. The treatment is symptomatic.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° c. do not freeze.