Full Prescribing Info
Contents
Miconazole nitrate, hydrocortisone.
Description
Each gram of cream contains 2.0% w/w miconazole nitrate and 1.0% w/w hydrocortisone with 0.16% w/w of chlorocresol as preservative.
Action
Pharmacology: Pharmacodynamics: Miconazole is an imidazole antifungal agent which interferes with ergosterol synthesis and thereby alters the permeability of the cell membrane of sensitive fungi. Hydrocortisone is a topically active corticosteroid which has anti-inflammatory action.
Pharmacokinetics: Miconazole has shown fungistatic activity, in vitro, against a number of fungi causing systemic mycoses such as Coccidioides immitis, Histoplasma capsulatum, Blastomyces dermatitides and Cryptococcus neoformans. Miconazole appears to act on the fungal cell wall and membranes inducing permeability changes which alter the ionic macromolecular composition of the effected cells. At high concentrations, Miconazole has shown fungicidal activity against various organisms. Miconazole readily penetrates the stratum corneum of the skin and persists there for more than 4 days after application. Less than 1% is absorbed into the blood. Absorption is no more than 1.3% from the vagina. Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive actions. When administered topically, particularly under occlusive dressing or when the skin is broken, sufficient corticosteroid may be absorbed to give systemic effects. Only unbound corticosteroids have pharmacological effects or are metabolised. They are metabolised mainly in the liver, also in the kidneys and are excreted in the urine.
Indications/Uses
Superficial fungal infection accompanied by inflammation, eczematous rash superinfected by fungus and/or gram positive bacteria.
Dosage/Direction for Use
Skin infection: Apply once or twice daily until lesion has disappeared.
Nail infection: Apply once daily and cover with bandage. Continue treatment until complete cure is observed.
Overdosage
Overdosage with Miconazole Nitrate in humans has not been reported to date.
Contraindications
It is contraindicated in individuals who are hypersensitive to it or any of its components, in untreated bacteria or viral lesions; rosacea (acne rosacea), perioral dermatitis.
Special Precautions
If irritation or sensitivity occurs, treatment should be discontinued. Avoid contact with eyes and mucous membranes (for external use only). Consult a doctor if no improvement occurs in 4 weeks (for athlete's foot) or 2 weeks (for jock itch). Discontinue therapy if sensitisation/irritation is reported during use. Avoid introduction of the drug into the eyes. Prolonged use of Miconazole, like any topical antimicrobial agent, may give rise to overgrowth of non susceptible organisms. Appropriate treatment should be given in the presence of infection. If there is no favourable response, treatment with the corticosteroid should be discontinued until the infection has been controlled. Corticosteroid applied to large areas of the skin can be absorbed in sufficient amount to produce systemic affects like adrenal suppression, manifestation of Cushing's Syndrome, hyperglycaemia and glycosuria in some patients. Thus suitable precautions should be taken during prolonged treatment, when treating extensive body surface area or when using the occlusive technique. Suitable precautions should also be taken when treating lesions complicated with stasis dermatitis or impaired circulation.
Paediatric Use: Do not use in children below 2 years except under medical advice.
Use In Pregnancy & Lactation
Use in pregnancy: Safety for use in pregnancy has not been establish. Since Miconazole Nitrate is absorbed in small amounts following topical administration, the drug should be used in the first trimester of pregnancy only if in the judgement of the treating clinician such treatment is considered essential to the welfare of the patient and the expected benefits outweigh any potential risks.
Use during lactation: It is not known whether or not Miconazole Nitrate is excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Miconazole is administered to a nursing mother.
Adverse Reactions
Dry skin, pruritus, irritation, mild to moderate transient burning/stinging. Local atrophic skin changes (prolonged and intensive treatment). Hypercorticism (systemic absorption on prolonged use). Itching, folliculitis, hypertrichoses, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, striae and miliaria.
Drug Interactions
Unknown.
Storage
Keep container well closed. Protect from strong light. Store below 30°C.
Recommended shelf life: 3 years.
ATC Classification
D01AC20 - imidazoles/triazoles in combination with corticosteroids ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Presentation/Packing
Cream (white) 15 g.
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