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active substances: betamethasone, clotrimazole, gentamycin; 1 g of the preparation contains betamethasone dipropionate micronized in terms of betamethasone 0.5 mg, clotrimazole 10 mg, gentamicin sulfate in terms of gentamicin 1 mg;
excipients: cetostearyl alcohol, polyethylene glycol stearate, white soft paraffin, mineral oil, propylene glycol, sodium dihydrogen phosphate anhydrous, concentrated phosphoric acid, sodium hydroxide, benzyl alcohol, purified water.

Dosage form. Cream for external use.

Pharmacotherapeutic group.
Corticosteroids for use in dermatology. Corticosteroids in combination with antibiotics. Betamethasone and antibiotics. PBX code D07C C01.

Clinical characteristics.

Dermatoses treatable with glucocorticosteroids, with suspected complications or complicated by a secondary infection caused by microorganisms sensitive to the components of the drug.
Clotrimazole is effective in the treatment of foot mycoses, inguinal epidermophytosis and trichophytosis of smooth skin caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, candidiasis caused by Candida albicans, and pityriasis versicolor caused by Malasseziarozurispurispuris spurt furs.

The drug is contraindicated in patients with hypersensitivity to active substances or to any other component of the drug. It is also contraindicated in case of skin tuberculosis, skin manifestations of syphilis, skin reactions after vaccination, common plaque psoriasis, varicose veins, perioral dermatitis, rosacea, chicken pox, other bacterial and fungal infections of the skin without proper antibacterial and antifungal therapy.

Dosage and administration.
Betazone ultra is applied in a thin layer on the entire affected surface and the adjacent area of ​​the skin 2 times a day, morning and evening. To obtain the effect, the drug should be used regularly. The duration of treatment depends on the size, location of the lesion and the patients response to treatment. Sometimes, if clinical improvement is not observed within 3-4 weeks, the diagnosis needs to be reviewed.

Adverse Reactions
Adverse reactions to treatment with Betazone Ultra are rare and include pigmentation disorders, hypochromia, burning sensation, erythema, exudation and itching.
Of the nearly 1000 patients who received local clotrimazole therapy for the treatment of dermo-tomycosis, 95% had good local tolerance. Side effects reported have been a burning sensation, blisters, peeling, swelling, itching, hives, and general skin irritation.
Gentamicin treatment can cause temporary irritation (erythema and pruritus), which usually do not require discontinuation of treatment.
Topical application of betamethasone (especially under occlusive dressings) can cause the following adverse reactions: burning sensation, itching, skin irritation, dry skin, folliculitis, hypertrichosis, acne-like rashes, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, development secondary resistant flora, atrophy of the skin, striae, prickly heat.

With prolonged or excessive use of local glucocorticosteroids, oppression of the pituitary-adrenal function is possible with the development of secondary adrenal insufficiency and the appearance of symptoms of hypercorticism, including Cushings disease. The use of clotrimazole under an occlusive dressing for 6 hours did not lead to the development of overdose symptoms. A single overdose of gentamicin did not lead to the appearance of symptoms of an overdose. Excessive or prolonged use of gentamicin can lead to excessive growth of antibiotic-insensitive microorganisms.
Treatment. Appropriate symptomatic therapy is prescribed. Symptoms of acute hypercorticism are usually reversible. If necessary, carry out the correction of electrolyte balance.In the case of chronic toxic effects, gradual withdrawal of corticosteroids is recommended. In case of excessive growth of resistant microorganisms, it is recommended to stop treatment with Betazone Ultra and prescribe the necessary therapy.

Use during pregnancy or lactation.
Due to the fact that the safety of the use of local corticosteroids for pregnant women has not been established, the appointment of these drugs is only possible if the expected benefit to the expectant mother clearly exceeds the potential threat to the fetus. Drugs in this group should not be used by pregnant women at high doses and for a long time.
It is not clear whether corticosteroids, when applied topically as a result of systemic absorption, can pass into breast milk, therefore, when deciding whether to stop breastfeeding or stop using the drug, it is necessary to consider the importance of treatment for the mother.

It is not recommended for children, since there is no experience with the use of the drug in this age category.

Features of the application.
Betazone Ultra is not intended for use in ophthalmology.
With the development of skin irritation or manifestations of hypersensitivity during treatment with cream, the use of the drug should be discontinued and the patient should be given adequate therapy. Any side effects that occur with the use of systemic corticosteroids, including inhibition of the function of the adrenal cortex, can also occur with topical use of glucocorticosteroids.
Cross allergic reactions with aminoglycosides were observed.
Systemic absorption of glucocorticosteroids or gentamicin with topical application will be higher if treatment is carried out on large surfaces of the body or when occlusive dressings are used, especially for long periods or in the presence of damaged skin areas.
Avoid applying gentamicin to open wounds or damaged skin. Otherwise, side effects may occur after systemic use of gentamicin.
Appropriate precautions should be followed in such cases.
Prolonged local use of antibiotics can sometimes lead to the growth of resistant microflora. In this case, as well as with the development of irritation, sensitization or superinfection during treatment with Betazone, ultra therapy should be discontinued and appropriate therapy should be prescribed.

The ability to influence the reaction rate when driving vehicles or other mechanisms.
Typically, the drug does not affect the reaction rate when driving or working with other mechanisms.

Interaction with other drugs and other types of interactions. The interaction is unknown.

Pharmacological properties.
Pharmacodynamics Betazone Ultra combines the anti-inflammatory, antipruritic, and sucking-up effects of betamethasone dipropionate with the broad antimycotic effect of clotrimazole and a wide spectrum of antibacterial activity of gentamicin sulfate. Clotrimazole has an antifungal effect on the cell membrane of fungi, leading to leakage of cellular contents.
It is effective for Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, candidiasis caused by Candida albicans, and Malassezia furtur (Pityrosporum obiculare).
Gentamicin provides a highly effective local treatment for primary and secondary bacterial skin infections.
Gentamicin is active against Staphylococcus aureus (coagulase-positive, coagulase-negative and some penicillinase-producing strains) and gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris pneumoniae and Klebsi.
Pharmacokinetics There are no data on the pharmacokinetics of the drug.

Pharmaceutical characteristics.
Basic physical and chemical properties: cream of white or almost white color, homogeneous consistency.

Shelf life. 2 years.

Storage conditions.Store in the original packaging at a temperature not exceeding 25 ° C.
Keep out of the reach of children.

Packaging. Cream for external use of 15 g or 30 g in tubes in a box.

Vacation category. On prescription.