Tetraderm®

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Available since: 2019-09-19

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Clinical Pharmacology

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

Indications

treatment of inflammatory dermatosis with concomitant bacterial and mycotic infection or a high probability of attaching a secondary infection (simple and allergic dermatitis, atopic dermatitis (including diffuse neurodermatitis), limited neurodermatitis, eczema, dermatomycosis (dermatophytosis, candidiasis, varicolor lichen), with localization in the groin and large folds of the skin;

simple chronic lichen (limited neurodermatitis).

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

Excipients: liquid paraffin (liquid petrolatum, mineral oil) - 120 mg, cetyl stearyl alcohol - 70 mg, propylene glycol - 50 mg, macrogol cetostearyl ether 6 - 20 mg, cetyl stearyl ether macrogol 25 - 20 mg, sodium dihydrogen phosphate dihydrate (one basic sodium sodium disodium phosphate ) - 2 mg, purified water - up to 1 g.

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Dosage and Administration

Topically. The cream is applied to the affected skin with a thin layer, gently rubbing, 2 times a day to achieve a positive clinical result. The duration of treatment is individual, depends on the size, location of the lesion and the severity of the disease and is usually 1-2 weeks. In case of ringworm, the average duration of treatment is 2-4 weeks. Tetraderm® is not recommended for more than 4 weeks. 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 use and in those doses that are specified in the instructions. If necessary, please consult a physician before using the drug.

Adverse reactions

Classification of the incidence of side effects 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; frequency unknown - according to the available data it is not possible to establish the frequency of occurrence

On the part of the skin: rarely - skin irritation, dry skin, skin burning sensation, itching, acne, skin atrophy (thinning and loss of elasticity), hypertrichosis (excessive hair growth), hypopigmentation (lightening), perioral dermatitis (rash or irritation around mouth), allergic contact dermatitis, skin maceration (softening of the upper layers of the skin), striae (stretch marks), prickly heat (skin irritation due to excessive sweating), papules and / or pustules (rash); frequency is unknown - skin hyperemia (redness), urticaria (blistering).

On the part of the nervous system: the frequency is unknown - paresthesia (tingling and numbness).

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

When applying external forms of corticosteroids for a long time and / or when used on large areas of the skin, or using occlusive dressings, side effects may occur that are characteristic of systemic corticosteroids, including adrenal insufficiency and Itsenko-Cushing syndrome.

Contraindications

Hypersensitivity to dexpanthenol, econazole, gentamicin, mometasone or any of the components that make up the drug;

skin vaccine reactions;

lupus;

skin manifestations of syphilis;

chickenpox;

herpes simplex;

open wound application;

rosacea;

perioral dermatitis;

age up to 18 years (efficacy and safety have not been established).

With care: pregnancy and breastfeeding; use on large areas of skin; long-term use; use in violation of the integrity of the skin; application of occlusive dressings.

Drug interactions

Studies of the interaction of the drug 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

Tetraderm is not intended for use in ophthalmology. The drug should not be allowed to enter the eyes and the periorbital area.

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

It should not be used to treat varicose trophic ulcers of the leg and open wounds. Some areas of the body (inguinal folds, armpits and the perianal region) are more at risk for striae, so the duration of the drug in these areas of the body should be limited.

If the use of the drug Tetraderm marked irritation or signs of hypersensitivity, treatment should be stopped and the patient should choose another therapy.

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 local corticosteroids may increase with prolonged use, treatment of large areas of the body, or the use of occlusive dressings.In such cases, the possible development of side effects characteristic of systemic corticosteroids.

It should be borne in mind that GCS can change the manifestations of certain skin diseases, which may make diagnosis difficult. In addition, the use of corticosteroids may cause delayed wound healing.

With long-term GCS therapy, the sudden cessation of therapy can lead to the development of 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, the tetraderm should be discontinued gradually.

Systemic absorption of gentamicin when applied topically may increase if applied to large areas of skin, especially with prolonged treatment or in the presence of damaged skin. With long-term use of the drug Tetraderm on the vast surfaces of the skin with impaired integrity, there is the potential for the absorption of gentamicin and, accordingly, the development of ototoxicity symptoms and other undesirable effects characteristic of gentamicin in its systemic use.

Perhaps the development of cross-allergic reactions to antibiotics from the group of aminoglycosides.

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

Influence on ability to drive vehicles and mechanisms. Data on the negative effect of the drug Tetroderm on the ability to drive vehicles and mechanisms, as well as to perform other activities that require concentration of attention and speed of psychomotor reactions, are not available.

Overdosage

Symptoms: long-term use of local corticosteroids in high doses may suppress adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's syndrome.

A single overdose of gentamicin is not accompanied by the appearance of any symptoms. Prolonged use or use in doses exceeding the recommended, can lead to a significant increase in insensitive microflora, including fungal, in the lesion.

Overdose of econazole when applied topically does not lead to the appearance of any symptoms.

With an overdose of dexpanthenol, when externally administered, no symptoms are expected.

Treatment: symptomatic. The acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance is shown.

When uncontrolled growth of insensitive microorganisms or the development of a fungal infection is uncontrolled, treatment should be stopped and appropriate therapy should be selected.