Batrafen Nail Lacquer

NAIL BATRAFEN has been specially developed for the treatment of fungal infections of the nails.

Ciclopirox is the free acid of ciclopiroxolamine. Ciclopirox has an identical spectrum of activity to ciclopiroxolamine. Ciclopirox is a hydroxypyridone derivative that is structurally unrelated to the imidazole derivatives or other antifungals.

In vitro ciclopirox has been shown to be both fungicidal and fungistatic as well as having sporicidal activity. Ciclopirox has activity against a broad spectrum of dermatophytes, yeasts, moulds and other fungi.

For most dermatophytes (Trichophyton species, Microsporum species, Epidermophyton species) and yeasts ( Candida albicans, Candida glabrata, other Candida species and Cryptococcus neoformans ) the MIC falls within the range of 0.9 to 3.9 g/mL. Some Aspergillus species are sensitive to ciclopirox as are some Penicillium species.

Ciclopirox has several mechanisms of action including chelation of polyvalent metal cations (eg Fe3+ and Al3+). It thus inhibits the metal-dependent enzymes including those responsible for the degradation of peroxides within microbial cells.

Ciclopirox has also demonstrated in vitro activity against many gram positive and gram negative bacteria (eg Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, relevant Staphylococcus and Streptococcus species), and Mycoplasma species, Trichomonas vaginalis and actinomyces . Most of the strains tested were in the range of 7.7 to 31.3 g/mL.

Ciclopirox is liberated from the lacquer vehicle in high concentrations and within a few hours. Ciclopirox readily penetrates into all parts of the nail rapidly producing fungicidal concentrations.

Ciclopirox penetrates the nail plate building up a gradient within 14 days of application depending on the nail condition. Penetration is more rapid and abundant in mycotic nails.

Nails with infection involvement of less than 60% of the nail plate, at the start of treatment, have a 4-5 times greater chance of clear regrowth compared to nails showing a higher involvement. 100% clearance rates have been shown in cases of 30% nail plate involvement. When more than 60% of the nail plate is involved clear regrowth may be reduced to a clinical improvement of approximately 30%. Some systemic absorption occurs but serum levels are very low.

Dosage

Adults

Unless otherwise directed, NAIL BATRAFEN lacquer is applied to the diseased nail in a thin layer every other day for the first month. This ensures that the nail is saturated with the active ingredient.

Application may be reduced to not less than twice weekly in the second month of treatment, and to once weekly from the third month of treatment onwards. Throughout the application period, the entire coating of lacquer is taken off once a week with the swab provided. If the coating of lacquer is damaged in the meantime, it is sufficient to paint over the chipped areas again with NAIL BATRAFEN lacquer.

The duration of application depends on the severity of the infection. A period of six months' treatment should not be exceeded because of a lack of clinical experience with NAIL BATRAFEN beyond this period of time. One bottle contains approximately 500 applications.

Children

Because of the lack of adequate clinical research, NAIL BATRAFEN lacquer is not recommended for use in children

Precautions

• People with hypersensitivity to Ciclopirox should avoid using this product
• Batrafen should not be used during pregnancy/lactation
• NAIL BATRAFEN is generally well tolerated. Where NAIL BATRAFEN lacquer has come into contact with skin adjacent to the nail a light reddening or scaling of the skin has been observed in a few exceptional cases.
• This is a "Pharmacist Only" Medicine.