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This cream is indicated for the topical treatment of inflammatory dermal infections like tinea pedis, tinea cruris, tinea corporis etc.
Dosage & Administration
Sufficient cream should be applied onto 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. The use of this cream for longer than four weeks is not recommended.
Adverse reactions reported for the preparation in clinical trials were paresthesia in 1.9% of patients, rash, edema and secondary infection, each in less than 1% of patients. Other adverse reactions reported with the preparation were burning and dry skin in 1.6% of patients and stinging in less than 1% of patients
Pregnancy & Lactation
There is inadequate evidence of safety in pregnancy. Clotrimazole has no teratogenic effect in animals but is foetotoxic at high oral doses. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. Hence the cream should only be used in pregnancy if the benefit justifies the potential risk to the fetus and such use should not be extensive,i.e. in large amounts or for long periods. It is not known whether the components of the preparation are excreted in human milk and therefore caution should be exercised when treating nursing mothers.
Use in Special Populations
The safety and effectiveness of the preparation have not been established in children below the age of 12 years.
Acute overdose with the cream is unlikely and would not be expected to lead to a life-threatening situation. The cream should not be used for longer than the prescribed time period.