Tetraderm cream for external use, 15g

Composition

Cream for external use of white or almost white color, uniform. 1 g mometasone furoate 0.5 mg, gentamicin sulfate 1 mg, econazole nitrate 10 mg, dexpanthenol 50 mg. Auxiliary substances: liquid paraffin (paraffin oil, mineral oil) 120 mg, alcohol cetylstearyl 70 mg, propylene glycol,50 mg, macrogol cetostearyl ether 6 – 20 mg, cetylstearyl live macrogol 25 to 20 mg, sodium dihydrogen phosphate dihydrate (monobasic sodium phosphate) 2 mg, purified water – up to 1 g.

the Pharmacological action of

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

Indications

Treatment of dermatoses of inflammatory origin 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, multi-colored lichen), especially if localized in the groin area and large skin folds;simple chronic lichen (limited neurodermatitis).

Use during pregnancy and lactation

No controlled studies have been conducted on the use of Tetraderm during pregnancy. Use during pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus. During pregnancy, Tetraderm should not be used on large areas of the skin or for a long period of time. Corticosteroids are excreted in breast milk. In this regard, during lactation, breast-feeding of the child or the use of Tetraderm by the mother should be discontinued.

Recommendations for use

Externally. The cream is applied to the affected areas of the skin in a thin layer, gently rubbing,2 times a day until a positive clinical result is achieved. The duration of treatment is individual, depending on the size, location of the lesion and severity of the disease, and usually lasts 1-2 weeks. With dermatomycosis of the feet, the average duration of treatment is 2-4 weeks. It is not recommended to use Tetraderm® for more than 4 weeks. If there is no improvement after treatment or new symptoms appear, you should consult your doctor. Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.

Contraindications

Hypersensitivity to dexpanthenol, econazole, gentamicin, mometasone or any of the components that make up the drug; skin post-vaccination reactions; skin tuberculosis; skin manifestations of syphilis; chickenpox; herpes simplex; use in the area of open wounds; rosacea; perioral dermatitis; age up to 18 years (efficacy and safety have not been established). With caution: pregnancy and lactation; use on large areas of the skin; long-term use; use in case of violation of the integrity of the skin; use of occlusive dressings.

Side effects

Classification of the frequency of side effects according to WHO recommendations: very common – ≥1/10; common – ≥1/100 to <1/10; infrequent – ≥1/1000 to <1/100; rare – ≥1/10000 to <1/1000; very rare — From the skin: rarely — skin irritation, dry skin, burning sensation of the skin, itching, acne, skin atrophy (thinning and loss of elasticity), hypertrichosis (excessive hair growth), hypopigmentation (lightening), perioral dermatitis (rash or irritation around the mouth), allergic contact dermatitis, maceration of the skin (softening of the upper layers of the skin), striae (stretch marks), sweating (skin irritation that develops due to increased sweating formation of papules and/or pustules (rash); frequency unknown — hyperemia of the skin (redness), urticaria (blistering). Nervous system disorders: frequency unknown-paresthesia (tingling sensation and numbness). Other: rarely-folliculitis (inflammation of the hair follicle), secondary infection. When using external forms of corticosteroids for a long time and/or when applied to large areas of the skin, or using occlusive dressings, side effects characteristic of systemic corticosteroids may occur, including adrenal insufficiency and Itsenko-Cushing syndrome.

Interaction

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

Overdose

Symptoms: long-term use of topical corticosteroids in high doses may lead to suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Itsenko-Cushing syndrome. A single gentamicin overdose does not cause any symptoms. Long-term use or use in doses exceeding the recommended ones can lead to significant growth of insensitive microflora, including fungal, in the lesion. Overdose of econazole with external use does not lead to the appearance of any symptoms. If dexpanthenol is overdosed on topically, no symptoms are expected to occur. Treatment: symptomatic. Acute symptoms of hypercorticism are usually reversible. If necessary, correction of the electrolyte imbalance is indicated. In case of uncontrolled growth of insensitive microorganisms or the development of a fungal infection, treatment should be discontinued and appropriate therapy should be selected.

Special instructions

Tetraderm is not intended for use in ophthalmology. Do not allow the drug to get into the eyes and on the periorbital area. Tetraderm cream is not recommended for use on the face and scalp. It is not recommended to use the drug under occlusal dressings, except when necessary. It should not be used for the treatment of varicose trophic ulcers of the lower leg and open wounds. Some areas of the body (inguinal folds, armpits and perianal area) are more at risk of developing striae, so the duration of use of the drug in these areas of the body should be limited. If irritation or signs of hypersensitivity are noted during the use of Tetraderm, treatment should be discontinued and another therapy should be selected for the patient. Any side effects that occur with the use of systemic corticosteroids, including suppression of the function of the adrenal cortex, can also be observed with external use of corticosteroids. Systemic absorption of topical corticosteroids may increase with prolonged use, treatment of large body surfaces, or the use of occlusive dressings. In such cases, it is possible to develop side effects characteristic of systemic corticosteroids. It should be borne in mind that corticosteroids can change the manifestations of certain skin diseases, which can make it difficult to make a diagnosis. In addition, the use of corticosteroids may delay wound healing. With long-term corticosteroid therapy, sudden discontinuation of therapy can lead to the development of rebound syndrome, which manifests itself in the form of dermatitis with intense redness of the skin and a burning sensation. Therefore, after a long course of treatment, Tetraderm should be discontinued gradually. Systemic absorption of gentamicin with external use may increase if applied to large areas of the skin, especially with prolonged treatment or in the presence of skin damage. With prolonged use of Tetraderm on large skin surfaces with impaired integrity, there is a potential for absorption of gentamicin and, accordingly, the development of symptoms of ototoxicity and other adverse events characteristic of gentamicin with its systemic use. It is possible to develop cross-allergic reactions to antibiotics from the aminoglycoside group. With prolonged external use of gentamicin, the growth of insensitive microflora, including fungal, may occur. In this case, as with the development of irritation, hypersensitivity reactions and superinfection, treatment should be discontinued and appropriate therapy should be prescribed. Influence on the ability to drive vehicles and mechanisms. There are no data on the negative effect of Tetraderm on the ability to drive vehicles and mechanisms, as well as perform other activities that require concentration of attention and speed of psychomotor reactions.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

2 years

Active ingredient

Gentamicin, Dexpanthenol, Mometasone, Econazole

Conditions of release from pharmacies

By prescription

Dosage form

ointment

Purpose

Pregnant women as prescribed by a doctor, Nursing mothers as prescribed by a doctor, For adults

Indications

Dermatosis, Neurodermatitis, Skin Fungus, Eczema, Skin Infections, Dermatitis