Batrafen Nail Lacquer

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

The active ingredient in Batrafen Nail Laquer, Ciclopirox penetrates the nail plate and reaches the fungal pathogen in as short a time as 48 hours after application.

Ciclopirox has a fungicidal action against all relevant pathogens responsible for fungal infections of the nails.

Active ingredient: Ciclopirox 8% Nail Lacquer

Please read this web page carefully before using BATRAFEN NAIL LACQUER.

This page answers some common questions about BATRAFEN NAIL LACQUER.  

BATRAFEN® NAIL LACQUER 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 µg/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 µg/mL.

Batrafen Nail Lacquer Pharmacokinetics:

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.

Batrafen Nail Lacquer Indications:

Fungal infections of the nails, caused by dermatophytes, yeasts or moulds.

Batrafen Nail Lacquer Dosage and Administration:

Before applying BATRAFEN® NAIL LACQUER for the first time, as much as possible of the affected nail material should be removed e.g. with scissors, and the remaining diseased nail roughened with a nail file. Unless otherwise directed, BATRAFEN® NAIL 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 a commercial nail varnish remover. During this process, as much as possible of the affected nail material should again be removed, using a nail file. If the coating of lacquer is damaged in the meantime, it is sufficient to paint over the chipped areas again with BATRAFEN® NAIL 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 BATRAFEN® NAIL LACQUER beyond this period of time.

One bottle contains approximately 500 applications.

Contraindications:

• Because of the lack of clinical experience, BATRAFEN® NAIL LACQUER is not recommended for use in children.
• Hypersensitivity to Ciclopirox.

Warnings and Precautions:

BATRAFEN® NAIL LACQUER should not be used in pregnancy or lactation unless considered absolutely essential. Consult your doctor first.

BATRAFEN® NAIL LACQUER is generally well tolerated. Where BATRAFEN® NAIL 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.

If you notice any adverse reactions, please consult your doctor.

Interactions:

Nil known.

Overdosage:

No overdosing effect by the topical route is known.

BATRAFEN® NAIL LACQUER Storage: 

• Protect from light (e.g. leave bottle in carton or replace it in carton after use).
• Keep out of the reach of children.
• Store at room temperature (below 25°C).
• Once the bottle has been opened BATRAFEN® NAIL LACQUER is stable for at least 6 months if stored as directed.

Special Notes:

• To prevent the solution from drying up, the cap must be firmly screwed down after use.
• To prevent the screw cap from sticking to the bottle, avoid spilling solution on the screw thread.

Medicine Classification: Pharmacist Only Medicine.

Package Quantities: 3g bottle.

Composition: Each gram of BATRAFEN® NAIL LACQUER contains, as active ingredient, 80mg Ciclopirox.

Excipients: copolymer of methylvinylether and maleic acid monobutyl ester, ethyl acetate, 2-propanol.

BATRAFEN® NAIL LACQUER supplied by:
Hoechst Marion Roussel (NZ) Limited
PO Box 112 042
Penrose
AUCKLAND

This page does not replace the advice of your doctor or pharmacist, nor does it contain all the available information about this medicine.

All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Batrafen Nail Lacquer does not require a prescription.

FREE WORLDWIDE DELIVERY - Batrafen Nail Lacquer

Do you have a question about Batrafen Nail Lacquer? Please address your query to info@strandarcadepharmacy.co.nz

Strand Arcade Pharmacy - Your New Zealand Online Pharmacy

© Strand Arcade Pharmacy - Batrafen Nail Lacquer