Presentation and Status in Health Basket
The nail ointment is applied in a thin layer to the infected nail once a day in a quantity sufficient to cover the entire nail surface.
The treatment with KERATOSPOR nail ointment should be carried out carefully each day and should be continued until no more of the softened, fungally infected nail substance can be scraped off. This usually takes 7-14 days, depending on the extent of the infection and the thickness of the nail.
After detachment of the nail, consequent antimycotic treatment of the nail bed should be carried out with AGISPOR cream once daily for about 4 weeks.
Method of administration: After application of the nail ointment the treated fingernail or toenail is covered with a plaster, and this dressing is left in place for 24 hours. The dressing should be changed daily; the finger or toe (or the hand or foot) should be bathed for about 10 minutes in warm water after removal of the plaster. After bathing in water, the softened infected nail substance is removed with the scraper. The treated nails are then dried, further KERATOSPOR nail ointment is applied as described above, and the nails are once again covered with the ready-to-use plaster.
It is not necessary to cover the skin surrounding the nail. However, if in exceptional cases irritation occurs, the edges of skin surrounding the nail should be covered with a suitable product, such as zinc paste, before fixing the plaster.
After detachment of the nail, i.e. before the start of the antimycotic follow-up treatment, the treating doctor should check that onycholysis has been completed, and, if necessary, give the nail bed a final cleaning.
Nail plates that are significantly dystrophic appear to respond better to avulsion with urea.
For nail stripping and antifungal treatment of fungal infections of the finger nails and toe nails.
Hypersensitivity to the active substance(s) or to any of the excipients.
Patients with a history of hypersensitivity reactions to other imidazole antifungal agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole containing products with caution.
If symptoms continue/persist after treatment, seek medical advice.
Skin and subcutaneous tissue disorders: Dermatitis contact, skin maceration, desquamation, nail disorder, nail discoloration, erythema, skin irritation, application site pain, pain in extremity, pruritus, rash.
These side effects are reversible after discontinuation of the treatment.
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: There are no data from the use of urea in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, if is preferable to avoid the use of urea (or the nail ointment) during the first trimester of pregnancy.
Lactation: It is unknown whether urea is excreted in human milk. Breast-feeding should be discontinued during treatment with urea or the nail ointment.
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.