Betamethasone dipropionate, gentamicin sulphate.
White cream contains 0.064% w/w of betamethasone dipropionate (equivalent to 0.05% of betamethasone) and 0.17% w/w of gentamicin sulphate (equivalent to 0.1% of gentamicin) with methyl paraben 0.16% & propyl paraben 0.03% as preservatives.
Betamethasone dipropionate is a topically active fluorinated corticosteroid which has anti-inflammatory, antipruritic and vasoconstrictive actions. Gentamicin sulphate is a broad spectrum aminoglycoside antibiotic which is bactericidal. It is effective against many strains of gram-negative bacteria and Staphylococcus aureus.
Pharmacology: Corticosteroids are extensively bound to plasma protein. Only unbound corticosteroids has pharmacological effects or is metabolised.
They are metabolised mainly in the liver and also in the kidney, and are excreted in the urine. Gentamicin sulphate is a bactericidal antibiotic which is active against a wide variety of pathogenic gram-positive and gram-negative bacteria. When applied topically to large areas of denuded body surface as the case of burn patients, plasma concentrations can reach 1mcg/ml, and 2% of the drug used may appear in the urine.
Treatment of impetigo, erythema and other localised primary bacterial skin infection with a Gram-negative component and also for secondary bacterial infections complicating other pre-existing dermatoses.
Apply to the affected area twice daily.
If hypothalamic-pituitary-adrenal axis suppression is found, then the drug should be withdrawn, frequency of application reduced or a weaker steroid used. Supplementary systemic corticosteroids may be required if signs and symptoms of steroid withdrawal occur.
Hypersensitivity to betamethasone dipropionate, gentamicin sulphate or any component in the base.
Use of topical gentamicin preparation in closed hospital settings is actively discouraged.
Discontinue use if irritation, sensitivity or other reaction develop and institute appropriate treatment. Corticosteroid applied to the skin can be absorbed in sufficient amount to produce systemic effects such as hypothalamic-pituitary-adrenal axis suppression, manifestation of Cushing's syndrome, hyperglycaemia and glucosuria. Thus suitable precautions should be taken during prolonged treatment, when treating extensive body surface areas, when using the occlusive technique and when treating children (because of larger skin surface area to bodyweight ratio). Safety of use of topical corticosteroids during pregnancy and lactation has not been established. Prolong use of a preparation containing an antibiotic may result in overgrowth of non susceptible organisms including fungi. If this occurs, discontinue use and institute appropriate therapy. Not suitable for ophthalmic use.
Reported local adverse reactions are burning sensation, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, maceration of the skin, secondary infection, skin atrophy, striae and miliria.
Ototoxicity and nephrotoxicity has been reported often in the topical treatment of severe burns with gentamicin. Hypersensitivity reactions have been reported after local use.
Keep container well closed. Protect from strong light. Store below 30°C.
Recommended shelf-life 3 years.
D07CC01 - betamethasone and antibiotics ; Belongs to the class of potent (group III) corticosteroids, in combination with antibiotics. Used in the treatment of dermatological diseases.
Cream (white) 15 g (tube), 450 g (jar).