APO-CICLOPIROX 8% w/w nail lacquer is a clear, colourless to slightly yellowish solution.
APO-CICLOPIROX is indicated for the topical treatment of fungal infections of the nails, caused by dermatophytes, yeasts or moulds, including tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporumcanis, candidiasis due to Candida albicans and tinea (pityriasis) versicolor due to Malassezia furfur.
Key word: Batrafen Nail Lacquer 8% 3g batrafen nail lacquer 3g solution
Dosage and Administration
1. Before starting treatment, remove any loose nail or nail pieces using nail clippers or nail files. If you have diabetes or problems with numbness in your toes or fingers, talk to your doctor before trimming your nails or removing any nail pieces.</
2. Apply APO-CICLOPIROX every other day for the first month (bedtime is best) to all affected nails with the applicator brush provided. 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. Apply APO-CICLOPIROX evenly over the entire nail and the skin right around the nail. Where possible, APO-CICLOPIROX should also be put on the bottom side of the nail and the skin beneath it. This ensures that the nail is saturated with the active ingredient. Let APO-CICLOPIROX dry (about 30 seconds) before putting on socks or stockings. After putting on APO-CICLOPIROX, wait 8 hours before taking a bath or shower.
3. Apply APO-CICLOPIROX over the previous coat.
4. Once a week (every 7 days), remove APO-CICLOPIROX with a commercial nail polish remover. Remove as much as possible of the damaged nail using scissors, nail clippers, or nail file.
5. Repeat process (steps 2 through 4).
Up to 48 weeks of using APO-CICLOPIROX every other day and having your doctor remove the loose, infected nail as often as monthly is usually how long it takes to get a clear or almost clear nail (which means that 10% or less of your nail is still affected). You may need as long as six months of treatment before you first notice your nail(s) getting better.
Because of the lack of clinical experience, APO-CICLOPIROX is not recommended for use in children.
Maximum Tolerated Daily Dose
APO-CICLOPIROX may be used up to one daily
Active Ingredient: ciclopirox 80mg/g Inactive Ingredients: butyl ester of PVM/MA copolymer, ethyl acetate, propyl alcohol.
Hypersensitivity to ciclopirox or any other component in the lacquer.
Warnings and Precautions
Patients should use the medication for the full treatment time as advise by the physician.
APO-CICLOPIROX must not be applied to the eye. APO-CICLOPIROX is a known eye irritant.
Care should be taken to ensure the patient does not inadvertently transfer APO-CICLOPIROX to the eyes by touching them after applying the lacquer to their fingernails.
APO-CICLOPIROX must not be taken orally and is not for vaginal use.
Patients should inform the physician if the area of application shows signs of increased irritation If a reaction suggesting sensitivity or chemical irritation should occur with the use of APOCICLOPIROX, treatment should be discontinued and appropriate therapy instituted.
So far there is no relevant clinical experience with patients who have a history of immunosuppression (e.g. extensive, persistent or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster or persistent herpes simplex), who are immunocompromised (e.g. HIV-infected patients, transplant patients), or have a diabetic neuropathy. These patients should be carefully evaluated as to the suitability of APOCICLOPIROX for use in treatment of fungal infection.
There is no clinical experience with the efficacy of APO-CICLOPIROX when used with cosmetic nail varnishes.
Use in children
Safety and effectiveness in children below the age of 18 years have not been established, therefore, APO-CICLOPIROX is not indicated for use in children.
Use in elderly patients
In clinical studies, no overall differences in safety were observed between elderly patients and
younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Avoid the use of occlusive dressings.
Use in Pregnancy
"Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of increased occurrence of foetal damage, the significance of which is considered uncertain in humans".
Reproduction studies revealed no significant evidence of impaired fertility in rats orally exposed to ciclopirox in dosages of up to 5mg/kg body weight (approximately 5 times the maximum recommended topical human dose based on surface area). No fetotoxicity due to ciclopirox was observed in the mouse, rat, rabbit and monkey at oral dosages of up to 100, 30, 30 and 50mg/kg body weight, respectively (approximately 37.5, 30, 44 and 77 times, respectively, the maximum recommended topical human dose based on surface area). By the dermal route of administration, no fetotoxicity due to ciclopirox was observed in the rat and rabbit at dosages of up to 120 and 100mg/kg body weight, respectively (approximately 121 and 147 times, respectively, the maximum recommended topical human dose based on surface area).
There are no adequate or well controlled studies of topically applied ciclopirox in pregnant women. APO-CICLOPIROX should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.