Instruction for use: Tetraderm

Active substance Gentamicin + Dexpanthenol + Mometasone + Econazole

ATX code D07XC03 Mometasone in combination with other drugs

Pharmacological group

Glucocorticosteroids in combinations

Nosological classification (ICD-10)

B35 Dermatophytosis

Lishay Grubi-Saburo, Lichen microsporic, Ringworm, fine-spore, Microsporosis, Dermatomycosis of the groin area and smooth skin, Mycosis of the skin and nails, caused by Trychophyton, Microsporia, Ringworm, Trichophytia, Epidermophytia

B35.6 The inguinal epidermophytosis

Fungal lesions of skin folds, Dermatomycosis of the groin area and smooth skin, Mycosis of the inguinal region, Inguinal dermatophytosis, Inguinal epidermophytosis, Inguinal dermatomycosis, Mycosis of feet and large folds

B36.0 Multicolored lichen

Lichen otripeda, Leesar multicolored, Lichen pityriasis furfuracea, Pitirosporum orbiculare, Multicolored lichen, Peregrine lichen

B36.9 Surface muriculation, unspecified

Fungal diseases of smooth skin, Fungal diseases of the skin, Fungal lesions of smooth skin of the body, Dermatomycosis, Dermatomycosis in large folds of the skin, Dermatomycosis of smooth skin, Dermatomycosis, Dermatomycosis smooth skin, Interdigital fungal erosion, Mycosis of the skin of the body, Mycosis complicated by secondary pyoderma, Chronic fungal infections, Epidermophytia of smooth skin

B37 Candidiasis

Visceral candidiasis, Invasive Candidiasis, Candidiasis of the larynx, Candidiasis of the digestive tract, Candidiasis of the skin and mucous membranes, Candidiasis of mucous membranes and skin, Candidiasis of the mucous membranes, Candidiasis caused by Candida albicans,Candidomycosis,Acute pseudomembranous candidiasis, Chronic forms of candidiasis

B37.2 Skin and Nail Candidiasis

Fungal paronychia, Fungal Eczema, Fungal dermatosis, Fungal diseases of smooth skin, Fungal lesions of smooth skin, Fungal lesions of smooth skin of the body, Fungal nail infections, Yeast Infection of the Skin, Candidiasis of the skin, Candidiasis of skin and mucous membranes of mouth and mouth, Candidiasis of the skin of nail ridges, Candidiasis of nail rollers, Candidiasis of nails, Candidiasis with lesions of the skin and mucous membranes, Candidiasis of mucous membranes and skin, Candida paronychia, Candidomycosis of the skin, Cutaneous candidal infections, Cutaneous candidiasis, Interdigital fungal erosion, Mycotic dermatitis, Paronychia candida, Superficial form of skin candidiasis, Superficial candidiasis, Superficial candidiasis of nails, Superficial mycosis of the skin, Chronic candidiasis of the skin

B49 Mycosis, unspecified

Common mycoses, Visceral mycosis, Deep endemic mycoses, Keratomycosis, Cutaneous mycosis, Pulmonary mycosis, Mycosis, Mycosis eyes, Mycoses of the gastrointestinal tract, Mycosis of large skin folds, Mycosis with secondary bacterial infection, Mycoses in patients with immunodeficiency, Systemic fungal infections, Tropical mycoses, Fungal infections of the skin, Fungal lesions of skin folds, Fungal infection, Fungal skin lesions, Fungal lesions of the bronchial mucosa, Fungal lesions of the oral mucosa, Infections fungal, Infections of skin fungal, Skin mycoses, Mycosis systemic, Mycosis of the mucous membranes

L20 Atopic dermatitis

Itchy atopic eczema, Common neurodermatitis, Allergic skin diseases, Allergic skin diseases of non-infectious etiology, Allergic skin diseases of non-microbial etiology, Allergic skin diseases, Allergic skin lesions, Allergic manifestations on the skin, Allergic dermatitis, Allergic diathesis, Allergic itching dermatosis, Allergic Skin Disease, Allergic skin irritation, Dermatitis allergic, Atopic dermatitis, Dermatosis allergic, Diathesis exudative, Skin Allergic Disease, Skin allergic reaction to medicinal and chemical preparations, Skin reaction to medication, Skin and allergic disease, Acute eczema, Chronic atopic dermatitis, Exudative diathesis, Itching allergic dermatosis

L20.8 Other atopic dermatitis

Constitutional neurodermatitis, Chronic neurodermatitis, Restricted neurodermatitis, Allergic eczema, Atopic eczema, Children's eczema, Diffuse neurodermatitis, Neurodermatitis, Neurodermatitis diffuse, Neurodermatitis limited, Neurodermatitis, Dermatosis of a neurogenic origin

L23 Allergic contact dermatitis

Allergic dermatitis, Purulent allergic dermatopathies, Contact allergic reaction, Contact allergic dermatitis, Photoallergic contact dermatitis

L28.0 Simple chronic lichen

Common lichen, Chronic and simple lichen, Chronic lichen

L30.3 Infectious dermatitis

Microbial skin infections, Dermatitis with concomitant bacterial infections, Dermatitis in the presence of a bacterial infection or suspected of it, Infected eczema of external auditory canal, Secondarily infected dermatosis, Erythema migrans, Secondarily infected dermatoses , Dermatitis re-infected, Infectious dermatitis, Dermatitis infected, Dermatoses complicated by a secondary infection, Dermatoses complicated by primary and secondary infection, Dermatoses complicated by primary and / or secondary infection, Infected eczema, Infected dermatitis, Infected dermatosis, Migrating erythema, Microbial eczema, Chronic migratory erythema, Eczema is infected, Erythema Migrating, Bacterial dermatitis, Erythema migratory chronic, Superinfectant dermatitis, Necrolytic Migrating erythema

L30.9 Dermatitis, unspecified

Allergic dermatoses complicated by a secondary bacterial infection, Anal eczema, Bacterial maturation, Varicose Eczema, Venous dermatitis, Inflammation of the skin, Inflammation of the skin upon contact with plants, Inflammatory Skin Diseases, Inflammatory skin reactions, Inflammatory processes of the skin, Hypostatic dermatitis, Fungal Eczema, Fungal dermatosis, Dermatitis, Dermatitis is stagnant, Dermatitis and eczema in the anal area, Dermatitis acute contact, Perianal dermatitis, Dermatosis, Dermatosis of the scalp, Dermatosis of psoriasis, Dermatosis with persistent itching, Dermatoses, Dermatoses itchy, Other itching dermatoses, Significant eczematous manifestations, Itching with, dermatoses, Itching eczema, True eczema, Skin reaction to insect bites,Skin itching with dermatosis, Constitutional eczema, Weeping eczema, Drowsing inflammatory skin disease, Dying Infectious-Inflammatory Skin Disease, Non-allergic dermatitis, Nummular eczema, Acute contact eczema, Acute inflammatory skin disease, Acute dermatosis, Acute severe dermatosis, Perianal dermatitis, Superficial dermatosis, Subacute Contact Eczema, Simple dermatitis, Occupational dermatitis, Psychogenic dermatosis, Bubble dermatitis of newborns, Pustular eruptions, Irritation and redness of the skin, Low-flammable eczema, Dry atrophic eczema, Dry eczema, Toxic dermatitis, Ear eczema like dermatitis, Chronic eczema, Chronic dermatosis, Chronic common dermatosis, Scaly papular dermatosis, Eczema, Eczema anal region, Eczema of the hands, Eczema Contact, Eczema lichenized, Eczema Nummular, Eczema acute, Eczema acute contact, Eczema subacute, Eczematous dermatitis, Eczema-like rashes, Ecome exogenous, Endogenous eczema, Gluteal dermatitis, Restricted itchy dermatitis

Composition

Cream for external use 100 g

Active substances:

Mometasone furoate 0.5 mg

Gentamycin sulfate 1 mg

(In terms of gentamicin)

Econazole nitrate 10 mg

Dexpanthenol 50 mg

Auxiliary substances: liquid paraffin (vaseline oil, mineral oil) - 120 mg; Cetostearyl alcohol - 70 mg; Propylene glycol 50 mg; Macrogol 6 cetostearyl ether - 20 mg; Macrogol 25 cetostearyl ether - 20 mg; Sodium dihydrogen phosphate dihydrate (monobasic sodium phosphate) - 2 mg; Purified water - up to 1g

Description of dosage form

Homogeneous cream white or almost white.

pharmachologic effect

Pharmacological action - anti-inflammatory, antibacterial, wound-healing, antifungal, glucocorticoid.

Pharmacodynamics

Combination drug for external use.

It has anti-inflammatory, antipruritic, anti-exudative, antibacterial, antifungal (fungicidal) and regenerative action. The activity of the drug is due to the pharmacological properties of the components that make up its composition.

Gentamicin. A broad-spectrum antibiotic from the aminoglycoside group. It is bactericidal and provides highly effective external treatment of primary and secondary bacterial skin infections. It is active against gram-negative microorganisms: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; Gram-positive microorganisms: Staphylococcus aureus (coagulase-positive, coagulase negative and some strains producing penicillinase).

Dexpanthenol is a derivative of pantothenic acid. Pantothenic acid - a water-soluble vitamin B (vitamin B5) - is an integral part of coenzyme A. Stimulates skin regeneration, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. The increase in the need for pantothenic acid is observed when the skin or tissues are damaged, and its deficiency can be compensated for by external application of dexpanthenol. Penetrates into all layers of the skin. It has a regenerating, weak anti-inflammatory effect.

Mometasone. Synthetic GCS, has a local anti-inflammatory, antipruritic and antiexudative action. SCS induces the release of proteins that inhibit phospholipase A2 and are known collectively as lipocortins that control the biosynthesis of inflammatory mediators such as PG and LT by inhibiting the release of their common precursor, arachidonic acid.

Econazole is a synthetic derivative of imidazole. Has antifungal and antibacterial action. It inhibits the biosynthesis of ergosterol, which regulates the permeability of the cell wall of microorganisms. It dissolves easily in lipids and penetrates well into tissues. It is active against dermatophytes Trichophyton, Microsporum, Epidermophyton, yeast-like fungi of the genus Candida, Corynebacterium minutissimum, and also Malassezia furfur (Pityrosporum orbiculare), which causes pungent lichen, and some gram-positive bacteria (streptococci, staphylococci).

Pharmacokinetics

Gentamicin. When topical application is absorbed in small amounts. Due to its low absorption, it practically does not have systemic effects.

Dexpanthenol. When applied externally, it is absorbed and converted to pantothenic acid, binds to blood plasma proteins. Pantothenic acid is not metabolized in the body and is excreted unchanged by the kidneys.

Mometasone. Absorption of mometasone for external use is low. After 8 hours after a single application on intact skin (without occlusive dressing), about 0.4% of the dose is found in the systemic blood stream. With inflammation and damage to the skin, absorption increases. Mometasone is extensively metabolized in the liver. It is excreted mainly by the kidneys and in a small amount - with bile.

Econazole. With external use, econazole penetrates all layers of the skin and the nail plate. Therapeutic concentrations are created in the horny and other layers of the epidermis, as well as in the dermis. When applied to the skin, systemic absorption is negligible. Less than 1% of the applied dose is excreted through the intestines and kidneys.

Indications

Treatment of dermatoses of inflammatory genesis with concomitant bacterial and mycotic infection or a high probability of secondary infection (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 dexpanthenol, econazole, gentamicin, mometasone or any of the components that make up the drug;

Cutaneous post-vaccination reactions;

lupus;

Cutaneous manifestations of syphilis;

chickenpox;

Herpes simplex;

Application in the field of open wounds;

Rosacea;

Perioral dermatitis;

Age to 18 years (efficiency and safety not established).

With caution: pregnancy and the period of breastfeeding; Application on large areas of the skin; Long-term use; Application in violation of the integrity of the skin; When using occlusive dressings.

pregnancy and lactation

Controlled studies of the use of Tetraderm® in pregnancy have not been conducted. Use in pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus. During pregnancy, do not use Tetraderm® on large areas of the skin or for a long period of time.

GCS (glucocorticosteroids) are excreted in breast milk. In this regard, during lactation, breastfeeding of the baby or the use of the Tetraderm® drug by the mother should be stopped.

Side effects

Classification of the incidence of adverse events according to WHO recommendations: very often - ≥1 / 10; Often from ≥1 / 100 to <1/10; Infrequently - from ≥1 / 1000 to <1/100; Rarely - from ≥1 / 10000 to <1/1000; Very rarely - <1/10000, including individual messages; The frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

On the part of the skin: rarely - skin irritation, dry skin, burning sensation, itching, acne, skin atrophy (thinning and loss of elasticity), hypertrichosis (excessive hair growth), hypopigmentation (bleaching), perioral dermatitis (rash or irritation around Mouth), allergic contact dermatitis, skin maceration (softening of the upper layers of the skin), striae (stretch marks), sweating (skin irritation that develops due to increased sweating), papules and / or pustules (rash); Frequency is unknown - skin hyperemia (redness), urticaria (the appearance of blisters).

From the side of the nervous system: the frequency is unknown - paresthesia (sensation of tingling and numbness).

Other: rarely - folliculitis (inflammation of the hair follicle), secondary infection.

When applying external forms of GCS for a long time and / or when applied to large areas of the skin, or with the use of occlusive dressings, there may be side effects that are characteristic of SCS of systemic action, including adrenal insufficiency and Itenko-Cushing syndrome.

Interaction

Studies of the interaction of Tetraderm® with other drugs have not been conducted, but it is not recommended to be used simultaneously with other drugs for external use.

Dosing and Administration

Outwardly. The cream is applied to the affected areas of the skin with a thin layer, gently rubbing, 2 times a day until a positive clinical result is achieved.

The duration of treatment is individual, depends on the size, localization of the lesion and the severity of the disease and is usually 1-2 weeks. With a dermatomycosis stop, the average duration of treatment is 2-4 weeks. For more than 4 weeks, Tetraderm® is not recommended.

If there is no improvement after treatment or new symptoms appear, it is necessary to consult a doctor. Use the drug only according to the method of administration and in the doses specified in the instructions. If necessary, consult a doctor before using the medication.

Overdose

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

A single overdose of gentamicin is not accompanied by the appearance of any symptoms. Long-term use or use in doses exceeding recommended, can lead to a significant increase in insensitive microflora, incl. Fungal, in the lesion.

Overdosage of econazole with external application does not lead to the appearance of any symptoms.

In case of an overdose of dexpanthenol in external application, no symptoms are expected.

Treatment: symptomatic. Acute symptoms of hypercorticism are usually reversible. If necessary, correction of electrolyte imbalance is shown.

With uncontrolled growth of insensitive microorganisms or the development of fungal infection, treatment should be discontinued and appropriate therapy selected.

special instructions

The drug Tetraderm® is not intended for use in ophthalmology. Do not allow the drug to enter the eyes and periorbital area.

Cream Tetraderm® is not recommended for use on the face and scalp. It is not recommended to use the drug under occlusive dressings, except when it is necessary.

It should not be used to treat varicose trophic ulcers of the lower leg and open wounds. Some areas of the body (inguinal folds, axillary hollows and perianal area) are more susceptible to the risk of streaking, so the duration of application of the drug in these areas of the body should be limited.

If there is irritation or signs of hypersensitivity when using Tetraderm®, treatment should be discontinued and the patient should be treated differently.

Any side effects that occur when using systemic GCS, including suppression of adrenal cortex function, can be noted even with external application of GCS. Systemic absorption of local GCS may increase with prolonged use, treatment of extensive body surfaces or the use of occlusive dressings. In such cases, the development of side effects, characteristic of systemic SCS, is possible.

It should be borne in mind that the GCS is able to change the manifestations of certain skin diseases, which can make it difficult to diagnose. In addition, the use of GCS may be a cause of delayed wound healing.

With prolonged therapy with SCS, sudden discontinuation of therapy can lead to the development of a rebound syndrome, manifested in the form of dermatitis with intense reddening of the skin and a burning sensation. Therefore, after a long treatment course, Tetraderm® should be phased out.

Systemic absorption of gentamicin for external application may increase in case of application to large areas of the skin, especially with prolonged treatment or if there are skin lesions. With long-term use of Tetraderm® on vast skin surfaces with compromised integrity, there is a potential for absorption of gentamicin and, accordingly, development of symptoms of ototoxicity and other undesirable phenomena characteristic of gentamicin in its systemic application.

It is possible to develop cross-allergic reactions to antibiotics from the aminoglycoside group.

With prolonged external application of gentamicin, growth of insensitive microflora, including fungal growth, can be observed. In this case, as with the development of irritation, reactions of hypersensitivity and superinfection, treatment should be stopped and appropriate therapy prescribed.

Impact on the ability to drive vehicles and mechanisms. Data on the negative effect of Tetraderm® on the ability to drive vehicles and mechanisms, as well as other activities that require concentration and speed of psychomotor reactions, are not available.

Form of issue

Cream for external use. For 15 or 30 grams in tubes of aluminum. Each tube in a pack of cardboard.

Conditions of leave from pharmacies

On prescription.

storage conditions

At a temperature not higher than 25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.