Product Overview
Composition
Cream for external use, white or almost white, homogeneous.
1 g mometasone furoate 0.5 mg,
gentamicin sulfate 1 mg,
econazole nitrate 10 mg,
dexpanthenol 50 mg.
liquid paraffin (liquid paraffin, mineral oil) - 120 mg,
cetyl stearyl alcohol - 70 mg,
propylene glycol - 50 mg,
macrogol cetostearyl ether 6 - 20 mg,
macrogol cetyl stearyl ether 25 - 20 mg,
sodium dihydrogen phosphate dihydrate (monobasic sodium phosphate) - 2 mg,
purified water - up to 1 g.
1 g mometasone furoate 0.5 mg,
gentamicin sulfate 1 mg,
econazole nitrate 10 mg,
dexpanthenol 50 mg.
Excipients:
cetyl stearyl alcohol - 70 mg,
propylene glycol - 50 mg,
macrogol cetostearyl ether 6 - 20 mg,
macrogol cetyl stearyl ether 25 - 20 mg,
sodium dihydrogen phosphate dihydrate (monobasic sodium phosphate) - 2 mg,
purified water - up to 1 g.
pharmachologic effect
Pharmacological action - anti-inflammatory, antibacterial, wound-healing, antifungal, glucocorticoid.
Indications
treatment of dermatoses of inflammatory genesis with concomitant bacterial and mycotic infections or a high probability of secondary infection (simple and allergic dermatitis, atopic dermatitis (including diffuse neurodermatitis), limited neurodermatitis, eczema, dermatomycosis (dermatophytosis, candidiasis, tinea versicolor), especially when localized in the groin and large folds of the skin; simple chronic lichen (limited neurodermatitis).
Application during pregnancy and lactation
There have been no controlled studies of the use of the drug Tetraderm during pregnancy.
In this regard, during lactation, breastfeeding of the child or the use of the drug Tetraderm by the mother should be stopped.
Use during pregnancy is possible only in cases where the intended benefit to the mother outweighs 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. GCS are excreted in breast milk.
In this regard, during lactation, breastfeeding of the child or the use of the drug Tetraderm by the mother should be stopped.
Recommendations for use
Outwardly. The cream is applied to the affected skin with 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 the severity of the disease and is usually 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 after treatment there is no improvement or new symptoms appear, you should consult your doctor.
Use the drug only according to the method of administration and in the doses indicated in the instructions.
If necessary, please consult your doctor before using the medicinal product.
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 after treatment there is no improvement or new symptoms appear, you should consult your doctor.
Use the drug only according to the method of administration and in the doses indicated in the instructions.
If necessary, please consult your doctor before using the medicinal product.
Contraindications
hypersensitivity to dexpanthenol, econazole, gentamicin, mometasone or any of the components that make up the drug; post-vaccination skin reactions; lupus; cutaneous manifestations of syphilis; chicken pox; herpes simplex; application in the field of open wounds; rosacea; perioral dermatitis; age up to 18 years (efficacy and safety have not been established).
With caution: pregnancy and breastfeeding; application on large areas of the skin; long-term use; use in violation of the integrity of the skin; the use of occlusive dressings.
With caution: pregnancy and breastfeeding; application on large areas of the skin; long-term use; use in violation of the integrity of the skin; the use of occlusive dressings.
Side effects
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 - from the available data, it is not possible to establish the frequency of occurrence.
On the part of 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 mouth), allergic contact dermatitis, skin maceration (softening of the upper layers of the skin), striae (stretch marks), prickly heat (skin irritation resulting from increased sweating), the formation of papules and / or pustules (rash); frequency unknown - flushing of the skin (redness), urticaria (blistering).
On the part of 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 mouth), allergic contact dermatitis, skin maceration (softening of the upper layers of the skin), striae (stretch marks), prickly heat (skin irritation resulting from increased sweating), the formation of papules and / or pustules (rash); frequency unknown - flushing of the skin (redness), urticaria (blistering).
From the nervous system: the frequency is unknown - paresthesia (tingling and numbness).
Others: rarely - folliculitis (inflammation of the hair follicle), secondary infection.
When using external forms of GCS for a long time and / or when used on large areas of the skin, or using occlusive dressings, side effects typical for GCS of systemic action may occur, including adrenal insufficiency and Itsenko-Cushing's syndrome.
Interaction
Studies of the interaction of the drug Tetraderm with other drugs have not been carried out, but it is not recommended to use it simultaneously with other drugs for external use.
Overdose
Symptoms: with long-term use of local corticosteroids in high doses, it is possible to suppress adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Itsenko-Cushing's syndrome.
Overdose of dexpanthenol when used topically is not expected to cause any symptoms.
Treatment: symptomatic. Acute symptoms of hypercortisolism are usually reversible.
Correction of electrolyte imbalance is indicated if necessary. 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.
A single overdose of gentamicin is not accompanied by the appearance of any symptoms. Prolonged use or use in doses exceeding the recommended ones can lead to a significant growth of insensitive microflora, incl. fungal, in the lesion focus.
An overdose of econazole when applied externally does not lead to the appearance of any symptoms.
Overdose of dexpanthenol when used topically is not expected to cause any symptoms.
Treatment: symptomatic. Acute symptoms of hypercortisolism are usually reversible.
Correction of electrolyte imbalance is indicated if necessary. 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
The drug Tetraderm is not intended for use in ophthalmology. Do not allow the drug to get into the eyes or 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 occlusive dressings, except when necessary. It should not be used to treat varicose ulcers of the leg and open wounds.
Certain areas of the body (groin folds, armpits and perianal region) are more at risk of striae, therefore, the duration of use of the drug in these areas of the body should be limited. If irritation or signs of hypersensitivity are noted when using the Tetraderm drug, treatment should be discontinued and the patient should be selected for another therapy. Any side effects that occur with the use of systemic corticosteroids, including inhibition of the function of the adrenal cortex, can be observed with external use of corticosteroids. Systemic absorption of local corticosteroids may increase with prolonged use, treatment of large 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 GCS can change the manifestations of some skin diseases, which can complicate the diagnosis. In addition, the use of GCS can be the cause of delayed wound healing. With prolonged therapy with GCS, a sudden cessation of therapy can lead to the development of rebound syndrome, manifested in the form of dermatitis with intense redness of the skin and a burning sensation. Therefore, after a long course of treatment, the abolition of the drug Tetraderm should be done gradually.
Systemic absorption of gentamicin when applied topically can be increased when applied to large areas of the skin, especially with prolonged treatment or in the presence of skin lesions. With long-term use of the drug Tetraderm on large surfaces of the skin with impaired integrity, there is a potential for the absorption of gentamicin and, accordingly, the development of symptoms of ototoxicity and other undesirable phenomena characteristic of gentamicin when used systemically. The development of cross-allergic reactions to antibiotics from the aminoglycoside group is possible.
With prolonged external use of gentamicin, the growth of insensitive microflora, including fungal, can be observed. In this case, as with the development of irritation, hypersensitivity reactions and superinfection, treatment must be discontinued and appropriate therapy prescribed.
Certain areas of the body (groin folds, armpits and perianal region) are more at risk of striae, therefore, the duration of use of the drug in these areas of the body should be limited. If irritation or signs of hypersensitivity are noted when using the Tetraderm drug, treatment should be discontinued and the patient should be selected for another therapy. Any side effects that occur with the use of systemic corticosteroids, including inhibition of the function of the adrenal cortex, can be observed with external use of corticosteroids. Systemic absorption of local corticosteroids may increase with prolonged use, treatment of large 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 GCS can change the manifestations of some skin diseases, which can complicate the diagnosis. In addition, the use of GCS can be the cause of delayed wound healing. With prolonged therapy with GCS, a sudden cessation of therapy can lead to the development of rebound syndrome, manifested in the form of dermatitis with intense redness of the skin and a burning sensation. Therefore, after a long course of treatment, the abolition of the drug Tetraderm should be done gradually.
Systemic absorption of gentamicin when applied topically can be increased when applied to large areas of the skin, especially with prolonged treatment or in the presence of skin lesions. With long-term use of the drug Tetraderm on large surfaces of the skin with impaired integrity, there is a potential for the absorption of gentamicin and, accordingly, the development of symptoms of ototoxicity and other undesirable phenomena characteristic of gentamicin when used systemically. The development of cross-allergic reactions to antibiotics from the aminoglycoside group is possible.
With prolonged external use of gentamicin, the growth of insensitive microflora, including fungal, can be observed. In this case, as with the development of irritation, hypersensitivity reactions and superinfection, treatment must be discontinued and appropriate therapy prescribed.
Influence on the ability to drive vehicles and mechanisms.
There are no data on the negative effect of the Tetraderm drug 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 the reach of children.
Shelf life
2 years
