Muscle relaxants & cholinesterase inhibitors
Clotrimazole10 mg- Betamethasone dipropionate 0,64 Equivalent Betamethasone 0,5 mg/1g
30g/Tube
CR-05
424/2005
7/8/2005
Mechanism Of Action | Clotrimazole is a broad-spectrum, antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes; yeasts, and Malassezia furfur. The primary action of clotrimazole is against dividing and growing organisms. Betamethasone dipropionate, a corticosteroid, is effective in the treatment of corticosteroid-responsive dermatoses primarily because of its anti-inflammatory, antipruritic, and vasoconstrictive actions. |
INDICATIONS | TRIMASONE is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis. |
CONTRAINDICATIONS | Hypersensitivity to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in this preparation. |
Side EFFECTS | Paresthesia; maculopapular rash, edema, and secondary infection may be associated with the use of TRIMASONE cream |
WARNINGS | Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Administration of topical dermatologics containing a corticosteroid to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children |
Pregnancy And lactations | TRIMASONE cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs containing corticosteroids should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Caution should be exercised when TRIMASONE cream is used by a nursing woman |
Dosage And Administration | : Gently massage sufficient TRIMASONE cream into the affected and surrounding skin areas twice a day, in the morning and evening, for 2 weeks in tinea cruris and tinea corporis and for 4 weeks in tinea pedis. Treatment with TRIMASONE cream should be discontinued if the condition persists after 2 weeks in tinea cruris and tinea corporis, and after 4 weeks in tinea pedis. Alternate therapy may then be instituted with a product containing an antifungal only. The use of TRIMASONE cream for longer than 4 weeks is not recommended. Clinical improvement, with relief of erythema and pruritus, usually occurs within 3 to 5 days of treatment. If a patient with tinea cruris or tinea corporis shows no clinical improvement after 1 week of treatment with TRIMASONE cream, the diagnosis should be reviewed. In tinea pedis, the treatment should be applied for 2 weeks prior to making that decision. TRIMASONE cream should not be used with occlusive dressings |
OVERDOSE | Acute overdosage with topical application of TRIMASONE cream is unlikely and would not be expected to lead to a life-threatening situation. Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. |
Storage Conditions | For external use only Keep out of reach of children. Store below 30°C. |