Micoral oral gel: Each gram contains Miconazole USP 20 mg.
Micoral oral gel is the preparation of Miconazole. It is a synthetic imidazole which exhibits broad spectrum activity against pathogenic dermatophytes, including Trichophyton species and yeasts including Candida species, Cryptococcus neoformans, Coccidioides immitis and Paracoccidioides brasiliensis as well as range of gram-positive cocci and bacilli. It acts by inhibiting membrane sterol synthesis and interfering with the permeability of the fungal cell membranes.
For oral administration : Dosage is based on 15 mg/ kg/ day.
Infants under 2 years: Half spoonful (2.5 ml) of gel twice daily.
Children aged 2-6 years: One spoonful (5 ml) of gel twice daily.
Children aged 6 years and over: One spoonful (5 ml) of gel four times daily.
Adult patients: One or two spoonfuls (5-10 ml) of gel four times daily.
In case of localized lesions of the mouth, a small amount of gel may be applied directly to the affected area with a clean finger, 2-4 times a day. For best results Micoral oral gel should be kept in contact with the affected area as long as possible. The treatment should be continued for up to two days after symptoms have cleared. For oral candidiasis, dental prosthesis should be removed at night and brushed with the gel. Elderly patients: Same as adult dose.
Preparation: Patients should be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated task.
Potent inhibitor of CYP2C9 and CYP3A4: significantly enhances anticoagulant action of warfarin causing severe bleeding (contraindicated with oral gel); increases phenytoin and sulfonylurea levels.
Miconazole is contraindicated in patients with known hypersensitivity to the active ingredient.
Less Common: Nausea, vomiting, diarrhea (prolonged use). Rare: Allergic reactions, hepatitis.
Overdose
In general Miconazole is not highly toxic. Accidental overdosage may cause vomiting and diarrhoea.
Category C. Avoid during pregnancy if possible; weigh potential hazards against possible maternal benefits. Lactation: Caution should be exercised when administered to a nursing woman.
Store below 25°C in a cool, dry place. Protect from light. Keep out of reach of children.