Ciclopirox

) Ciclopirox Topical Solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum .

The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.

• No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended.

• Ciclopirox Topical Solution, 8% should be used only under medical supervision as described above. • The effectiveness and safety of ciclopirox topical solution, 8% in the following populations has not been studied. , extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy.

TARO-CICLOPIROX (ciclopirox topical solution, 8% w/w) NAIL LACQUER should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail - as frequently as monthly - by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy.

Careful consideration of the appropriate nail management program should be given to patients with diabetes. ) Nail Care By Health Care Professionals: Removal of the unattached, infected nail - as frequently as monthly- trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in the treatment of nail disorders.

Nail Care By Patient:

Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after TARO-CICLOPIROX is removed with isopropyl alcohol. TARO-CICLOPIROX should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided.

Mild to moderate fungal infections of the nails caused by dermatophytes, yeasts and moulds, without nail matrix/lunula involvement. Onytec 80 mg/g medicated nail lacquer is indicated in adults.