Description
Release form
Cream for external use
Pharmacological action
Pharmacological action – anti-inflammatory, antibacterial, wound healing, antifungal, glucocorticoid.
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 (dermatophytosis lichen), especially when localized in the inguinal region and large folds of the skin
simple chronic lichen (limited neurodermatitis).
Special instructions
Tetraderm is not intended for use in ophthalmology. Do not allow the drug to get into the eyes and on the periorbital region.
Tetraderm Cream is not recommended for use on the skin of the face and scalp. The use of the drug under occlusive dressings is not recommended, except when necessary.
Should not be used to treat varicose trophic ulcers of the lower leg and open wounds. Some parts of the body (inguinal folds, axillary hollows and the perianal region) are more at risk of striae, therefore, the duration of the drug in these parts of the body should be limited.
If irritation or signs of hypersensitivity are noted with the use of the Tetraderm drug, treatment should be discontinued and other therapy should be selected for the patient.
Any side effects encountered with the use of systemic corticosteroids, including inhibition of the function of the adrenal cortex, can also occur with external use of corticosteroids. Systemic absorption of local corticosteroids 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 corticosteroids is possible.
It should be borne in mind that corticosteroids are capable of changing the manifestations of certain skin diseases, which may complicate the diagnosis. In addition, the use of corticosteroids can be a reason for the delay in wound healing.
With prolonged treatment with corticosteroids, a sudden cessation of therapy can lead to the development of rebound syndrome, which manifests itself 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 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 lesions. With prolonged use of the Tetraderm preparation on vast skin surfaces with impaired integrity, there is a potential possibility of absorption of gentamicin and, accordingly, the development of symptoms of ototoxicity and other undesirable effects characteristic of gentamicin in its systemic use.
Perhaps the development of cross-allergic reactions to antibiotics from the aminoglycoside group.
With prolonged external use of gentamicin, an increase in insensitive microflora can be observed, including fungal. In this case, as with the development of irritation, hypersensitivity reactions and superinfection, treatment should be stopped and appropriate therapy prescribed.
Impact 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 types of activities that require concentration and speed of psychomotor reactions.
Composition
Cream for external use white.
1 g
mometasone furoate 0.5 mg
gentamicin sulfate 1 mg
econazole nitrate 10 mg
dexpanthenol 50 mg
Excipients:
paraffin liquid (liquid paraffin, mineral oil) – 200 ml alcohol, 80 ml alcohol, mg 50 mg,
macrogol cetostearyl ether 6 – 20 mg,
cetyl stearyl ether macrogol 25 – 20 mg,
sodium dihydrogen phosphate dihydrate (monobasic sodium phosphate) – 2 mg,
purified water – up to 1 g.
Dosage and Administration
Externally. The cream is applied to the affected areas of the skin with a thin layer, gently rubbing it, 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.
Tetraderm ® is not recommended for more than 4 weeks. If, after treatment, improvement does not occur or new symptoms appear, it is necessary to consult a doctor.
Use the drug only according to the method of use and at the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.
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 is very rare - <1/10000, including individual messages the frequency is unknown - according to the available data, it is not possible to establish the frequency of occurrence. From the skin: rarely – skin irritation, dry skin, burning sensation, 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), the formation of papules and / or pustules (rash), the frequency is unknown – skin hyperemia (redness), urticaria (blisters). From the nervous system: frequency unknown – paresthesia (tingling 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 applying to large areas of the skin, or using occlusive dressings, side effects characteristic of systemic corticosteroids can occur, including adrenal insufficiency and Itsenko-Cushing’s syndrome. Drug Interactions No studies have been conducted on the interaction of the Tetraderm drug with other drugs, however, it is not recommended to be used simultaneously with other medicinal products for external use. Overdose Symptoms: with prolonged use of local corticosteroids in high doses, suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercorticism, including Itsenko-Cushing’s syndrome, is possible. 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 increase in insensitive microflora, including fungal, in the lesion focus. An overdose of econazole when applied topically does not lead to any symptoms. With an overdose of dexpanthenol for external use, no symptoms are expected. Treatment: symptomatic. The acute symptoms of hypercorticism are usually reversible. If necessary, correction of electrolyte imbalance is indicated. With uncontrolled growth of insensitive microorganisms or the development of a fungal infection, discontinue treatment and choose the appropriate therapy. Storage conditions At a temperature not exceeding 25 ° C. Keep out of the reach of children. Expiration and 2 years Deystvuyuschee substances Gentamicin, Dexpanthenol, mometasone, konazol Form of Treatment mazy
