INDICATIONS: Gelmicin Cream 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 (Pityrosporon orbiculare).
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.
Action: Gelmicin ® Cream combines the anti-inflammatory, antipruritic and vasoconstrictive betamethasone dipropionate sustained action with broad spectrum antifungal effect of clotrimazole and antibiotic gentamicin. Clotrimazole appears to act on the cell membrane of the fungus, causing loss of cell contents. Gentamicin provides a highly effective topical treatment in primary and secondary bacterial infections of the skin.
Pharmacokinetics in Humans: Clinical experience suggests that the degree of absorption of betamethasone dipropionate cream has not been associated with clinically significant adverse effects when used as directed. Therefore, additional studies are required.
In one study, 1% clotrimazole cream was administered daily to the intact or injured skin of rabbits for three weeks without producing measurable serum levels. Similar results were obtained with 1% clotrimazole cream administered radiolabeled intact or inflamed skin of humans.
Were detected at very low levels (0001 mg / l) in serum clotrimazole and urine drug concentration was less than 0.5% of the amount administered to the skin.
However, when administered orally, clotrimazole is rapidly and almost completely absorbed and distributed throughout the body within hours. Higher concentrations of the drug were found in liver, adipose tissue and skin.
In the rat, clotrimazole absorbed is eliminated predominantly (over 90%) in the feces within 48 hours. Similarly, in humans, approximately 25% of the drug is excreted in urine and feces in the rest for about 6 days.
Betamethasone dipropionate, as is characteristic for corticosteroids are absorbed through the skin, is reversibly bound to plasma protein, and is metabolized in both hepatic and extrahepatic sites and results substances, mostly inactive and excreted almost completely within 72 hours.
In vivo studies were conducted to determine the distribution of gentamicin after subcutaneous administration. Activity assays were performed gentamicin 1,2,3 and 4 hours after injection by plates of tissue samples obtained at necropsy agar Staphylococcus aureus. The tissue injection site showed inhibition during 4 hours. Activity was also found in kidney, lung, heart, small intestine, blood, urine, liver, muscle and spleen. The stool showed no activity in any period.
Experiments were also conducted to establish the pattern of excretion and levels in blood and urine. To this effect, gentamicin was injected intramuscularly and the samples were analyzed for activity at 1,4,8 and 24 hours.
Peak blood levels were obtained at 0.5 hours and almost complete excretion occurred within the first 24 hours. After intravenous administration, no significant effects were found in urine flow, electrolyte excretion, release of creatinine or glomerular filtration rate. The antibiotic was rapidly excreted by the kidneys in a release rate close to the rate of infusion. Further experiments determined that the binding capacity of serum gentamicin sulfate is 25 to 30%.
CONTRAINDICATIONS: 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.
RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION: The prolonged topical antibiotics may occasionally result in overgrowth of non-susceptible organisms. If this occurs or if irritation supervene, hypersensitivity or superinfection with using Gelmicin ®, treatment should be discontinued and initiate appropriate therapy.
It has been shown that there is cross allergenicity aminoglycosides.
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 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 for prolonged use of gentamicin.
Gelmicin ® Cream is not for ophthalmic use.
Use during pregnancy and lactation has not been established as the harmlessness of topical corticosteroids in pregnant women, the drugs in this class should be used during pregnancy only if the potential benefit justifies 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 intracranial hypertension.
Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include outstanding fontanelle, headaches and bilateral papilledema.
ADVERSE REACTIONS: In very rare cases have reported adverse reactions to treatment with Gelmicin ® Cream 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. Of almost 1,000 patients treated with topical clotrimazole for their dermatomycosis, 95% showed excellent tolerance.
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.
DRUG INTERACTIONS AND OTHER GENDER: None reported to date.
CHANGES IN RESULTS OF LABORATORY TESTS: None reported to date.
PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: None reported to date.
DOSAGE AND ADMINISTRATION: Skin.
Must be applied a thin layer of Gelmicin ® Cream to completely cover the affected area and surrounding skin twice daily, morning and evening. For treatment to be effective, Gelmicin ® 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.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION
Symptoms: 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 of 0.0001 mcg / ml) of radioactive material in the serum of humans, very little probable that an overdose by topical administration. An overdose of gentamicin alone may not cause symptoms. The prolonged and excessive topical use of gentamicin can cause overgrowth of non susceptible.
Treatment: symptomatic treatment is indicated appropriate. Hipercorticoideos acute symptoms are virtually reversible. If necessary, treat electrolyte imbalance. In case of chronic corticosteroids should be discontinued gradually.
If proliferation occurs microorgansimos susceptible, treatment should be discontinued Gelmicin ® Cream and appropriate therapy instituted.