Indications

For the topical treatment of inflamed dermatoses, such as intertrigo and infected eczema, where infection by susceptible organisms and inflammation coexist. Eczema or dermatitis, including atopic eczema, primary irritant or contact allergic eczema, or seborrheic eczema, including acne-related eczema Interiginous eczema, including inflammatory intrigue, perianal, and genital dermatitis, is also treated with this medication. Dermatophytes and pathogenic yeasts (e.g. Candida spp.) are vulnerable to miconazole, as are numerous Gram-positive bacteria, including several strains of Streptococcus and Staphylococcus.

Pharmacology

Miconazole is a substituted imidazole that belongs to the azole family and is used to treat superficial candidiasis, dermatophytosis and pityriasis versicolor, acanthamoeba, and seborrheic dermatitis. Aspergillus spp., Cryptococcus neoformans, Pseudalescheria boydii, and some gram-positive bacteria such as Staphylococci and Streptococci are also susceptible.

Dosage & Administration

Apply to the affected area as a thin film two or four times daily for 1 to 2 weeks. Rub it well with your finger until this cream fully vanished on the skin. Treatment should be continued at least one week after the disappearance of all signs and symptoms. The same dosage applies to both adults and children.

Interaction

Amphotericin antagonizes the effect of miconazole. Contraindications The drug is contraindicated in individuals with a history of sensitivity reactions to Miconazole or any of the components of the preparation, viral disease of the skin (herpes, chickenpox), perioral dermatitis, rosacea, ulcerative conditions, tuberculous or syphilitic processes.

Contraindications

Individuals who are hypersensitive to it or any of its components should avoid it. Without the advice of a physician, it should not be taken in pregnant or lactating mothers.

Side Effects

Generally, it is well tolerated. An allergic reaction to any of the ingredients of the cream may occur. Rarely, irritation & burning may occur.

Pregnancy & Lactation

Administration of corticosteroids to the pregnant animal at high doses can cause abnormalities of fetal development. Topical steroids should not be extensively used in pregnancy. Precautions & Warnings It should be used with caution when applied to extensive surface areas or under occlusive dressings including baby napkins. Application to the face should be avoided.

Precautions & Warnings

Only on a licensed physician’s prescription can it be dispensed. Keep out of children’s reach. In the case of long-term use in youngsters and the elderly, exercise caution or seek medical advice.

Therapeutic Class

Miconazole nitrate is an imidazole antifungal drug with antibacterial properties. It is used in combination with hydrocortisone. It interacts with fungal cytochrome P450 at low doses, preventing a demethylation step in the formation of ergosterol. At high concentrations, miconazole interacts with membrane lipids causing direct membrane damage which results in the leakage of fungus cell constituents. It appears that fungistatic effects result from the inhibition of membrane sterol synthesis and membrane. Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and the reversal of increased capillary permeability. It may also be used as replacement therapy for adrenocortical insufficiency.

Storage Conditions

Protect from light and moisture.

Generic Name

Miconazole Nitrate + Hydrocortisone

Pharmaceutical Name

ACI Limited