Presentation and Status in Health Basket
To achieve a lasting cure, treatment with AGISPOR cream, solution and gel must be carried out reliably and over an adequate period. The usual periods of treatment are:
Foot mycoses (Tinea pedis, tinea pedum interdigitalis): 3 weeks.
Mycoses of the trunk, hands and skin folds (Tinea corporis, tinea manuum,
tinea inguinalis): 2-3 weeks.
Pityriasis versicolor: 2 weeks.
Erythrasma: 2 weeks.
Superficial candidiasis of the skin: 2-4 weeks.
Use in Children: No in-depth studies have been performed in children. From a survey of the clinical data reported there is no indication that harmful effects should be anticipated in children. However, in infants and toddlers, the medicinal product should only be used under medical supervision.
Method of administration:
Solution is used once a day, preferably in the evening, before retiring. It should be applied thinly to the affected skin area and rubbed in.
A few drops (about 3 drops) is generally sufficient to treat an area of about the
size of the palm of the hand.
Broad spectrum antimycotic agent.
Hypersensitivity to the active substance(s) or to any of the excipients.
Pregnancy, lactation. Avoid contact with eyes.
Slight reddening, burning, irritation, scaling may occur rarely, usually transient.
Limited data suggest that an interaction between topical bifonazole and warfarin may be possible, leading to increases in INR. If bifonazole is used in a patient on warfarin therapy, they should be appropriately monitored.
Pregnancy and Lactation
Pregnancy: Preclinical safety data and pharmacokinetic data in humans give no indication that harmful effects on the mother and child should be anticipated when bifonazole is used during pregnancy. However, no clinical data are available. As a precautionary measure, it is preferable to avoid the use of bifonazole during the first trimester of pregnancy.
Lactation: It is unknown whether bifonazole is excreted in human breast milk.
The excretion of bifonazole in milk has been studied in animals. Available pharmacodynamic/toxicological data in animals have shown excretion of bifonazole/metabolites in milk. Breast-feeding should be discontinued
during treatment with bifonazole.
No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion.
Shelf-life: 60 months.
Storage: store below 25°C.