(1997; 132 pages) [French] [Spanish]
Powder, ointment, cream or oral gel, 2% (20 mg/ml) miconazole nitrate
Miconazole is a synthetic imidazole active against fungi (both dermatophytes and yeasts) and Gram-positive cocci (Staphylococcus and Streptococcus spp.).
• Treatment of superficial fungal infections of the skin caused by both dermatophytes and yeasts and of secondary infections caused by Gram-positive cocci. Specific indications include ringworm, intertrigo, diaper dermatitis and chronic paronychia due to Candida spp., fungal infections of the outer ear and pityriasis (tinea) versicolor.
• Treatment of vaginal candidosis.
• Treatment and prevention of oral candidosis and denture stomatitis.
Dosage and administration
All doses are suitable for adults and children.
Superficial fungal infections and secondary infections:
A thin layer of cream or ointment should be applied twice daily to all affected areas. Treatment should be continued for 14 days after symptoms have resolved. Powder can be used in association with the cream or ointment and also dusted in clothes, footwear and bedding.
A dose of 10 ml (200 mg) of a specially formulated cream should be inserted high into the vagina on 3 consecutive nights.
Oral candidosis and denture stomatitis:
A dose of 5 ml (100 mg) of gel should be applied four times daily to all affected areas and retained in the mouth for as long as possible before swallowing. Treatment should be continued for 7 days after lesions have cleared.
• Known hypersensitivity to azole derivatives.
• Severe liver impairment.
Treatment should be discontinued if irritation or sensitivity occurs. Miconazole should not come in contact with the eyes.
Use in pregnancy and lactation
Topically applied miconazole is not systemically absorbed and can be used safely during pregnancy and lactation. No adverse effects have been reported in infants born to mothers who have been treated with oral miconazole during pregnancy and lactation.
Isolated cases of sensitization have been reported, characterized by irritation and a burning sensation and necessitating discontinuation of treatment.
Preparations should be stored in a cool place, protected from light.