Indication
For the topical treatment of inflamed dermatoses where?ÿ infection by susceptible organisms and inflammation coexist e.g. intertrigo and infected eczema. For moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrheic eczema including that associated with acne. Also for interiginous eczema including inflammatory interigo, perianal and genital dermatitis. Organisms which are?ÿsusceptible to miconazole are dermatophytes and pathogenic yeasts (e.g. Candida spp.): also many Gram-positive bacteria including many strains of Streptococcus and Staphylococcus.
Pharmacology
Miconazole nitrate is an imidazole antifungal agent and possesses antibacterial activity. At low concentrations, it interacts with fungal cytochrome P450 which results in inhibition of a demethylation step in the biosynthesis of ergosterol. At high concentrations, miconazole interacts with membrane lipids causing direct membrane damage which results in leakage of fungus cell constituents. It appears that fungistatic effects result from the inhibition of membrane sterol synthesis and membrane. Hydrocortisone is a naturally occurring glucocorticoid that is now prepared by chemical synthesis and its main action is to reduce the response of the skin to injury (i.e. anti-inflammatory). It also has immunosuppressant and antimitotic actions. The anti-inflammatory activity of hydrocortisone is its main therapeutic property. This is thought to be mediated by the reduction in formation, release and action of the various vasoactive chemicals release during inflammation-kinins, histamine, lysosomal enzymes, prostaglandins and the complement system. Steroids decrease membrane permeability and bind to tissue receptors. They also induce vasoconstriction, by reducing vascular permeability and reversing vascular dilation which in turn decreases serum extravasation, swelling and discomfort, including itching. Thus, they effectively reduce cellular access to inflamed sites. Corticosteroids also exhibit an antimitotic effect against human epidermal cells which may account for their effectiveness in the treatment of scaly dermatoses such as psoriasis.
Dosage
It should be applied topically to the affected area two or three times daily. The same dosage applies to both adults and children. In infants, long term continuous topical corticosteroid therapy should be avoided. Occlusive dressing is usually only necessary in the case of nail lesions. Once the inflammatory symptoms have disappointed (after about 7 days) treatment can be continued where necessary with this cream.
Interaction
Amphotericin antagonises effect of miconazole.
Contradiction
Hypersensitivity to any of the ingredient. Tubercular or viral infections of the skin or those caused by gram negative bacteria.
Side Effect
Rarely local sensitivity may occur. Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
Pregnancy
Administration of corticosteroids to pregnant animal at high doses can cause abnormalities of fetal development. Topical steroids should not be extensively used in pregnancy.
Precaution
It should be used with caution when applied to extensive surface areas or under occlusive dressings including baby napkins. Application to the extensive surface areas of the face should be avoided. In infants, long term continuous topical corticosteroid therapy should be avoided. Adrenal suppression may occur even without occlusion.
Overdose
Storage
Keep below 25?øC temperature, away from light & moisture. Keep out of the reach of children.