Ciclodan

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Avoid contact with the eyes, nose, and inside of the mouth. If this does happen, rinse with water.

Avoid using other medications on the areas you treat with ciclopirox topical unless your doctor tells you to.

Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with ciclopirox nail lacquer.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

• Tell all of your health care providers that you take Ciclodan. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you use other drugs or products on your skin.
• This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Ciclodan while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• To gain the most benefit, do not miss doses.
• Do not take Ciclodan by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Ciclopirox Topical Solution, 8%, (Nail Lacquer), is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ciclopirox Topical Solution, 8%, (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 (see PRECAUTIONS).

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 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 Ciclopirox Topical Solution, 8%, (Nail Lacquer), is removed with alcohol.

Ciclopirox Topical Solution, 8%, (Nail Lacquer), should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. The Ciclopirox Topical Solution, 8%, (Nail Lacquer), should be applied evenly over the entire nail plate.

If possible, Ciclopirox Topical Solution, 8%, (Nail Lacquer), should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

The Ciclopirox Topical Solution, 8%, (Nail Lacquer), should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.

NDC 43538-500-06

Rx Only
Ciclodan®
Ciclopirox Topical Solution, 8% (Nail Lacquer)

FOR DERMATOLOGIC
USE ONLY

NOT FOR USE IN EYES

1 Bottle - 6.6 mL

MEDIMETRIKS
PHARMACEUTICALS, INC.

There are no data on the excretion of ciclopirox topical into human milk. Because ciclopirox is not absorbed, little excretion would be expected. The manufacturer recommends that caution be used when administering ciclopirox to nursing women.

Substance Name

Ciclopirox

CAS Registry Number

29342-05-0

Drug Class

Antiinfective Agents

Antifungal Agents