Local treatment of bacterial skin disorders responding to treatment with corticosteroids, in patients over 13 years of age. It is used in case of suspicion or bacteriological confirmation of skin infection caused by gentamicin-sensitive bacteria such as sensitive streptococcal strains (group A streptococcus: alpha- and beta-haemolysis), staphylococcus aureus (coagulase positive and coagulase positive strains and some penicillinase producing strains) and bacteria Gram-negative:Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris andKlebsiella pneumoniae.
Composition:
1 g of Ointment or cream contains 0.5 mg of betamethasone in the form of betamethasone dipropionate and 1 mg gentamycin in the form of Gentamicin sulphate. The cream formulation contains cetostearyl alcohol and chlorocresol.
Action:
A topical preparation with a combined effect of betamethasone and gentamicin. Betamethasone is a synthetic fluorinated corticosteroid with a strong action for topical use. It has a strong anti-inflammatory, antipruritic and decongestant effect on blood vessels. Gentamicin is an aminoglycoside antibiotic. It works on Streptococcus (groups A: alpha- and beta-haemolysing), Staphylococcus aureus (coagulase positive and coagulase positive strains, and some strains that produce penicillinase), as well as Gram-negative bacteria, including:Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris andKlebsiella pneumoniae. When administered on the skin, corticosteroids are absorbed in 12-14%. Approx. 64% of betamethasone is bound to plasma proteins. It is metabolised in the liver, and its metabolites are excreted primarily in the urine. Gentamicin sulfate after topical application on intact skin is absorbed to a minimal extent, while absorption after application on damaged skin can reach up to 5%. Gentamicin is poorly bound to plasma proteins and is excreted unchanged by the kidneys.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Skin tuberculosis. Viral skin infections. Acne, dermatitis around the mouth, rosacea. Do not use around the anus and genitals. Diaper dermatitis. Fungal infection of the skin. Skin infections with gentamycin-resistant bacteria.
Precautions:
Do not use the preparation on the scalp. If a skin allergic reaction occurs after applying the preparation, it should be immediately discontinued. Avoid contact of the preparation with eyes and mucous membranes. Do not use on eyes or around eyes. It is not recommended to apply to the face due to the risk of skin inflammation (similar to acne-like lesions), dermatitis, skin disappearance and acne. In the case of fungal skin infections, topical treatment with antifungal drugs should be applied. Due to the risk of systemic side effects of corticosteroids (including adrenal suppression) and gentamicin (oto- and nephrotoxicity, especially in patients with impaired renal function), the drug should be avoided for large body surface area, damaged skin, use in high doses and long-term use in patients with impaired liver function and in children. Use only the absolutely necessary cases for the skin of the armpits and groin, due to the increased absorption. The drug should be used with particular caution in patients with psoriasis, because topical use of corticosteroids in psoriasis can be dangerous, including 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 skin dysfunction. Long-term topical use of gentamicin sulphate leads to excessive growth of non-susceptible microorganisms and may result in the emergence of bacteria resistant to aminoglycoside antibiotics. It is not recommended for children up to 12 years of age due to frequent reports of side effects in the form of suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome and increase in intracranial pressure after topical use of potent corticosteroids. If the use of the drug is necessary, special precautions should be taken. The cream formulation contains cetostearyl alcohol, which can cause a local skin reaction (e.g., contact dermatitis) and chlorocresol, which can cause allergic reactions.
Pregnancy and lactation:
The use of the drug during pregnancy is only allowed in cases where the benefit for the mother outweighs the risk to the fetus. Use should be short-lived and limited to a small area of the body. A decision should be made whether to discontinue breast-feeding or discontinue the preparation, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother. The preparations should not be applied to the breast skin before breast-feeding.
Side effects:
Local application of betamethasone dipropionate may cause atrophic skin changes, irreversible stretch marks, dry skin, small arterioles, folliculitis, hypertrichosis, acne-like lesions, allergic contact dermatitis (burning, swelling and inflammatory blisters on the skin), dermatitis around the mouth, itching, discoloration of the skin, inhibition of sweat glands (prickly) and the occurrence of secondary infections. The topical use of gentamicin may result in hypersensitivity reactions in the form of, e.g. rash, itching, redness, edema. As a result of the absorption of active substances into the blood, there may also be general side effects of betamethasone and gentamicin. General side effects are rare, especially in the case of long-term use of the drug, use on a large area of the skin, under closed composure and use in children and usually disappear after discontinuation of the preparation.
Dosage:
Outwardly. Adults and children from 13 years of age: a thin layer of the preparation should be covered with affected lesions on the skin 1 or 2 times a day. Do not use a closed (occlusive) dressing. In some cases, less frequent use of the preparation is sufficient to maintain a therapeutic response.
(C)
