Each 100 g of cream contain:
Betamethasone 50 mg
Clotrimazole 1 g
Gentamicin 0.1 g
It is indicated for the relief of inflammatory manifestations of dermatoses responsive to steroids, complicated by a secondary infection caused by organisms sensitive to the components of this dermatologic preparation or suspected the possibility of such infection.
Clotrimazole has proven effective in the treatment of tinea pedis, jock itch and ringworm due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis; candidiasis caused by Candida albicans and tinea versicolor due to Malassezia furfur.
Bacteria susceptible to the action of gentamicin include sensitive strains of streptococci (group A beta-hemolytic, alpha hemolytic), Staphylococcus aureus (coagulase positive, negative and coagulase-penicillinase producing strains) and Gram-negative bacteria Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.
Cream combines the anti-inflammatory, antipruritic and vasoconstrictive sustained by the betamethasone dipropionate with broad spectrum antifungal action and the effect of clotrimazole antibiotic gentamicin. Clotrimazole appears to act on the fungus cell membrane, causing loss of cell content of the fungus. Gentamicin provides a highly effective topical treatment in primary and secondary bacterial infections of the skin.
DOSAGE AND ADMINISTRATION:
Cutaneous: Must apply a thin layer of cream to completely cover the affected area and surrounding skin twice daily, morning and evening.
For treatment to be effective, the cream should be applied regularly.
The duration of the treatment varies and depends on the extent and location of the disease, as well as the patient's clinical response. However, if no improvement is achieved in three or four weeks, the diagnosis must be considered again.
Its use is contraindicated in patients with a history of hypersensitivity to any component of the formula. Not for use in tuberculous lesions of the skin, herpes simplex viral and acute varicella or during the vaccination period. Should not be used near the eyes.
The prolonged use of topical antibiotics may cause the proliferation of microorganisms non-susceptible . If this occurs or if irritation supervene, hypersensitivity or superinfection with the use of the cream, the treatment should be discontinued and initiate appropriate therapy.
Any side effects associated with systemic use of corticosteroids, including adrenal suppression may also occur with topical corticosteroids, especially on infants and children.
Systemic absorption of topical corticosteroids or gentamicin may increase, if treated extensive body surface areas or used occlusive dressing.
Avoid application of gentamicin in open wounds or damaged skin. Under these conditions, appropriate measures should be taken, particularly in infants and children.
Not recommended the prolonged use of gentamicin.
BARMICIL COMPUESTO® is not for ophthalmic use.
RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING:
As the safety of topical corticosteroids in pregnant women has not been established , the drugs in this class should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
Drugs of this class should not be used extensively or for prolonged periods in pregnant patients.
As it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk, you should decide to discontinue nursing or the drug use, taking into account the importance of drug to the mother.
Pediatric Use: Pediatric patients may exhibit more sensitive than adults to the suppression of the hypothalamic-pituitary-adrenal (HPA) induced by topical corticosteroids and effects of exogenous corticosteroids.
This is because in children the surface area ratio between the skin and the body weight is higher and consequently the absorption is higher.
In children receiving topical corticosteroids have been reported depressive episodes HPA axis, Cushing syndrome, linear growth retardation, delayed weight gain and hypertension.
Rarely have reported adverse reactions to treatment and have included them hypochromia, burning, erythema, exudation and pruritus.
The following local adverse reactions have also been reported with the use of local corticosteroids, especially when used under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Adverse reactions that have been reported include: rash, itching, blistering, peeling, edema, pruritus, urticaria and general irritation of the skin.
Treatment with gentamicin produced transient irritation (redness and itching) that usually does not require treatment discontinuation.
None reported to date.
OVERDOSE OR ACCIDENTAL INGESTION:
The excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency manifestations of hypercorticism, including Cushing's syndrome.
Since the application of radiolabelled C14 clotrimazole to intact or injured skin under occlusive dressing for six hours, did not produce measurable amounts (minimum detection limit 0.0001μg/ml) of radioactive material in the human serum, is has a very low probability that occurs an overdose by use of topical administration. An overdose of gentamicin alone may not cause symptoms. The prolonged and excessive topical use of gentamicin can cause proliferation of nonsusceptible microorganisms.
Treatment: symptomatic treatment is indicated appropriate. If necessary, treat electrolyte imbalance. In case of chronic toxicity is recommended to discontinue the use of corticosteroids gradually.
If there is a proliferation of susceptible microorganisms, should be discontinued and use the appropriate therapy.
Carton and aluminum tube internally coated with epoxy-phenolic resin 30 g.
Keep out of reach of children.
Laboratorios Quimica SON’S, S.A. de C.V.