Tetraderm, cream 15 g

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, pityriasis versicolor), especially when localized in the groin area and large folds of the skin;
simple chronic lichen (limited neurodermatitis).

Pharmacological effect

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

Special instructions

Tetraderm is not intended for use in ophthalmology. Do not allow the drug to come into contact with the eyes or 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. Should not be used to treat varicose trophic ulcers of the leg and open wounds.

Some areas of the body (inguinal folds, armpits and perianal area) are more at risk of developing stretch marks, so the duration of use of the drug in these areas of the body should be limited.

If irritation or signs of hypersensitivity are observed when using Tetraderm, treatment should be discontinued and the patient should be given another therapy. Any side effects encountered 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 long-term use, treatment of large areas of the body, or 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 GCS can change the manifestations of some skin diseases, which can complicate the diagnosis. In addition, the use of corticosteroids may cause a delay in wound healing.

With long-term therapy with GCS, 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, Tetraderm should be discontinued gradually.

Systemic absorption of gentamicin when applied topically may be increased when applied to large areas of skin, especially during long-term treatment or in the presence of damaged skin.

With long-term use of the drug Tetraderm on large surfaces of the skin with impaired integrity, there is a potential for absorption of gentamicin and, accordingly, the development of symptoms of ototoxicity and other undesirable effects characteristic of gentamicin when used systemically. It is possible to develop cross-allergic reactions to antibiotics from the aminoglycoside group.

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

Impact on the ability to drive vehicles and machinery.

Active ingredient

Gentamicin, Dexpanthenol, Mometasone, Econazole

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.

Excipients:

Pregnancy

There have been no controlled studies of the use of Tetraderm during pregnancy.

Use during pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

Contraindications

Hypersensitivity to dexpanthenol, econazole, gentamicin, mometasone or any of the components included in the drug; skin post-vaccination reactions; lupus; skin manifestations of syphilis; chicken pox; herpes simplex; application in the area of ​​open wounds; rosacea; perioral dermatitis; age under 18 years (efficacy and safety have not been established).

With caution: pregnancy and breastfeeding; application on large areas of skin; long-term use; use for violation of the integrity of the skin; 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; uncommon - from ≥1/1000 to <1/100; rarely - from ≥1/10000 to <1/1000; very rarely - <1/10000, including isolated reports; frequency unknown - based on available data, it is not possible to determine the frequency of occurrence.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, skin maceration (softening of the upper layers of the skin), stretch marks (stretch marks), heat rash (skin irritation that develops as a result of increased sweating), the formation of papules and/or pustules (rash); frequency unknown – skin hyperemia (redness), urticaria (blistering).From the nervous system: frequency unknown – paresthesia (tingling and numbness).

Interaction

Studies of the interaction of the drug 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: with long-term use of local corticosteroids in high doses, suppression of adrenal function with the development of secondary adrenal insufficiency and symptoms of hypercortisolism, including Itsenko-Cushing syndrome, is possible.

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

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, depends on the size, location of the lesion and the severity of the disease and is usually 1-2 weeks.

For tinea pedis, 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.

Storage conditions

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

Shelf life

2 years

Manufacturer

Vertex, Russia