Tetraderm® (Tetraderm®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspTOfor external use.
Composition:

1 g of cream contains:

active substances: mometasone furoate - 0.5 mg; gentamycin sulfate 1.0 mg (in terms of gentamicin); econazole nitrate - 10.0 mg; dexpanthenol 50.0 mg;

Excipients: paraffin liquid (vaseline oil, mineral oil) 120.0 mg; cetostearyl alcohol - 70.0 mg; propylene glycol 50.0 mg; macrogol 6 cetostearyl ether - 20.0 mg; macrogol 25 cetostearyl ether - 20.0 mg; sodium dihydrogen phosphate dihydrate (monobasic sodium phosphate) - 2.0 mg; water purified to 1.0 g.

Description:

Homogeneous cream white or almost white.

Pharmacotherapeutic group:glucocorticosteroid for topical use + antibiotic-aminoglycoside + antifungal agent + tissue repair stimulant
ATX: & nbsp
  • Mometasone in combination with other drugs
    • Pharmacodynamics:

    Combination drug for external use.

    Has anti-inflammatory, antipruritic, antiexudative, antibacterial, antifungal (fungicidal) and regenerative effect. 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.

    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

    Dexpanthenol is a derivative of pantothenic acid. Pantothenic acid is 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 demand 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 glucocorticosteroid (GCS), has a local anti-inflammatory, antipruritic and antiexudative action. SCS induces the release of phospholipase-inhibiting proteins A2 and known collectively as lipocortins that control the biosynthesis of inflammatory mediators like prostaglandins and leukotrienes by inhibiting the release of their common arachidonic acid precursor.

    Econazole

    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.

    Active in relation to dermatophytes Trichophyton, Microsporum, Epidermophyton, yeast-like fungi of the genus Candida, Corynebacterium minutissimum, and Malassezia furfur (Pityrosporum orbiculare), causing pityriasis, and some gram-positive bacteria (streptococci, staphylococci).

    Pharmacokinetics:

    Gentamicin

    When used externally, it 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 intensively metabolized in the liver. It is excreted mostly by the kidneys and in an insignificant quantity with bile.

    Econazole

    With external application econazole penetrates into 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 with a high probability of secondary infection (simple and allergic dermatitis, atopic dermatitis (including diffuse neurodermatitis), limited neurodermatitis, eczema, dermatomycosis (dermatophigia, 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 to any of the components that make up the drug;

    - dermal post-vaccination reactions;

    - lupus;

    - cutaneous manifestations of syphilis;

    - chickenpox;

    - herpes simplex;

    - application in the field of open wounds;

    - rosacea;

    - perioral dermatitis;

    - children under 18 years of age (efficacy and safety not established).

    Carefully:

    - 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:

    Pregnancy

    Controlled studies of the use of Tetraderm® during 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.

    Breastfeeding period

    GCS is excreted in breast milk.In this regard, you should stop breastfeeding or use Tetraderm® as a nursing mother.

    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 severity of the disease and is usually 1-2 weeks. In the case of dermatomycosis, 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 the doses specified in the instructions. If necessary, please consult with your doctor before using the medication.

    Side effects:

    Classification of the incidence of adverse events according to the recommendations of the World Health Organization (WHO):

    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.

    From the skin:

    seldom - a skin irritation, dry skin, feeling of skin burning, itching, acne, skin atrophy (thinning and loss of elasticity), hypertrichosis (excess hair growth), hypopigmentation, perioral dermatitis (rash or irritation around the mouth), allergic contact dermatitis, maceration skin (softening of the upper layers of skin), striae (stretching), heat rash (skin irritation, develops due to increased sweating), the formation of papules and / or pustules (rash);

    frequency unknown - skin hyperemia (redness), urticaria (the appearance of blisters).

    From the nervous system:

    frequency is unknown - paresthesia (sensation of tingling and numbness).

    Other:

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

    When applying the external forms of corticosteroids for a long time and / or when applied to large areas of skin, or by using occlusive dressings can have side effects that are characteristic for corticosteroids system action, including adrenal insufficiency and Isenko-Cushing syndrome.

    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. Prolonged use or use in doses exceeding recommended, can lead to a significant increase in insensitive microflora, including fungal, in the lesion.

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

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

    Treatment

    Symptomatic. Acute symptoms of hypercorticoidism 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.

    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.

    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. Do not use the drug under occlusive dressings, except when necessary.

    Do not use 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 SCS, 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 GCS, 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 the 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 course of treatment, 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 prolonged use of Tetraderm® on the vast surfaces of the skin with compromised integrity, there is the potential for absorption of gentamicin and, accordingly, the 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.

    Effect on the ability to drive transp. cf. and fur:

    Data about the negative impact Tetraderm® drug on ability to drive and use machines, as well as perform other activities that require concentration and speed of psychomotor reactions, no.

    Form release / dosage:

    Cream for external use.

    Packaging:

    For 15 g or 30 g in an aluminum tube.

    Each tube together with instructions for use in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003766
    Date of registration:04.08.2016
    Expiration Date:04.08.2021
    The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspVERTEKS CJSC VERTEKS CJSC Russia
    Information update date: & nbsp08.10.2016
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