Symptomatic treatment of inflammatory skin changes responsive to corticosteroids, complicated by secondary infections caused by gentamicin-sensitive and Clotrimazole sensitive organisms. Clotrimazole has been shown to be effective in the treatment of topical inguinal, groin, foot and non-scalp skin. Clotrimazole applied on the skin has antifungal activityTrichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum andMicrosporum canis, candidiasis caused byCandida albicans and pityriasis dandruff caused byMalassezia furfur (Pityrosporum obiculare).The gentamicin-sensitive bacteria include strains of streptococci (groups A: β-hemolyzing, α-haemolysing), staphylococcus aureus (coagulase-positive strains, coagulase-negative strains and some penicillinase producing strains) and Gram-negative bacteria, such as:Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.
Composition:
1 g of Ointment or cream contains 0.5 mg of betamethasone in the form of betamethasone dipropionate, 10 mg of clotrimazole and 1 mg gentamycin in the form of Gentamicin sulphate. In addition, the cream contains cetostearyl alcohol and propylene glycol.
Action:
The properties of the preparation result from the combined action of the active substances: betamethasone dipropionate, gentamicin and clotrimazole. Betamethasone dipropionate is a potent corticosteroid. When applied topically, it has a fast and long-lasting anti-inflammatory, anti-pruritic and decongestant effect. Gentamicin is an aminoglycoside antibiotic with a broad spectrum of antibacterial activity. Clotrimazole belongs to the imidazole group with a broad spectrum of antifungal activity. It inhibits the growth of fungi that cause skin diseases. Clotrimazole acts on the cell wall of the fungus. Resistance to clotrimazole is rare, it was found in the caseCandida guilliermondi. Repeated exposure of strainsCandida albicans and Trichophyton mentagrophytes did not create resistant strains.
Contraindications:
Hypersensitivity to betamethasone dipropionate, clotrimazole or gentamycin, or to other corticosteroids, imidazole derivatives, aminoglycoside antibiotics or to the rest of the preparation. Viral skin infections (eg chickenpox, herpes). Rosacea. Common acne. Primary bacterial and fungal skin infections. Do not use on wounds, damaged skin, facial skin, around the anus and genitals, and inflammation of the skin around the mouth. Do not use long-term.
Precautions:
In the event of irritation, sensitization or secondary infection, discontinue use and apply appropriate treatment. Long-term topical use may lead to the growth of gentamycin-resistant microbial strains and other aminoglycoside antibiotics. There was the occurrence of cross-allergy to aminoglycoside antibiotics. Do not use the product in the eyes and around the eyes and mucous membranes. Systemic absorption of topical corticosteroids or gentamicin increases after use of occlusive dressings. During the use of the preparation, there is a risk of systemic side effects of corticosteroids (including adrenal suppression) and gentamicin (oto- and nephrotoxicity, especially in people with impaired renal function); Avoid using the drug on a large area of the body, using it in high doses and using occlusive dressings. Particularly caution should be used in patients with psoriasis, due to the recurrence of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis and general toxic effects caused by disturbance of skin continuity. In children, inhibition of the hypothalamic-pituitary-adrenal axis was more frequent than in adults after topical use of corticosteroids, due to the increased absorption resulting from the large skin surface area to body weight.In children treated with topical corticosteroids, Cushing's syndrome, growth slowdown, decreased body weight gain and increased intracranial pressure were also reported. Symptoms of adrenal insufficiency are low plasma cortisol levels and no response to ACTH stimulation. The symptoms of increased intracranial pressure include: bulging fontanelles, headaches and bilateral swelling of the optic disc. The cream formulation contains cetostearyl alcohol, which can cause a local skin reaction (e.g., contact dermatitis) and propylene glycol, which can cause skin irritation. The ointment preparation should not be used in children under the age of 2 years.
Pregnancy and lactation:
The preparation can be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the mother, fetus or newborn. A decision should be made to discontinue breast-feeding or use, taking into account the importance of the drug to the mother. During breast-feeding, do not use the drug on the skin of the breast.
Side effects:
Very rare: skin discoloration, non-pigmented anemia, burning sensation, erythema, exudation and pruritus. In addition, side effects may also occur, which have been observed after the topical use of corticosteroids, clotrimazole and gentamicin. Due to the content of betamethasone dipropionic, burning sensation, pruritus, irritation, dry skin, folliculitis, hypertrichosis, posteroid acne, discoloration of the skin, dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, may occur. stretch marks and perspiration. As a result of the absorption of betamethasone dipropionate into the blood, general side effects, characteristic of corticosteroids, may also occur. These symptoms occur primarily in the case of long-term use of the preparation, its use on a large area of the skin and use in children. In case of hypersensitivity symptoms, treatment should be stopped immediately. Due to clotrymazole content, erythema, burning sensation, blistering, exfoliation, swelling, pruritus, urticaria and general skin irritation may occur. Due to gentamicin content skin irritation (erythema and pruritus) may occur, which usually does not require discontinuation of treatment.
Dosage:
Outwardly. Apply a thin layer of ointment or cream twice daily (morning and evening) to the affected lesions and the surrounding skin. The preparation should be used regularly. The duration of treatment depends on the size and location of lesions and the patient's response to treatment. If there is no improvement after 3-4 weeks, the diagnosis should be verified. Ointment: in children over 2 years can be used no longer than for 5 days.
(C)
