Ciclopirox 8% Nail Lacquer Top Soln
It is used to treat fungal infections of the nails.
Drug Class
Antifungal, Topical
Pharmacologic Class
Hydroxypyridone Antifungal
Pregnancy Category
Category B
FDA Approved
Dec 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciclopirox nail lacquer is a medicine applied directly to your nails to treat fungal infections. It works by stopping the growth of the fungus that causes the infection. It's important to use it regularly for many months to see the best results, as nails grow slowly.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your nails and the surrounding skin. Avoid getting it in your mouth, nose, ears, or eyes.
Use the medication daily on your nails and nail beds.
Apply the medication 8 hours before bathing or showering.
Once a week, remove the medication with rubbing alcohol. Gently file away any loose nail material and trim your nails as instructed by your doctor.
Do not use nail polish or other nail products while using this medication.
Storage and Disposal
Store the medication at room temperature.
Keep the medication in its original outer carton to protect it from light.
Ensure the lid is tightly closed when not in use.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your nails and the surrounding skin. Avoid getting it in your mouth, nose, ears, or eyes.
Use the medication daily on your nails and nail beds.
Apply the medication 8 hours before bathing or showering.
Once a week, remove the medication with rubbing alcohol. Gently file away any loose nail material and trim your nails as instructed by your doctor.
Do not use nail polish or other nail products while using this medication.
Storage and Disposal
Store the medication at room temperature.
Keep the medication in its original outer carton to protect it from light.
Ensure the lid is tightly closed when not in use.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Clean and dry nails thoroughly before application.
- Apply once daily, preferably at bedtime, to the entire nail plate and surrounding skin.
- Once a week, remove the lacquer with rubbing alcohol to ensure better penetration of new applications.
- Trim or file away any loose or infected nail material weekly.
- Avoid using cosmetic nail polish or artificial nails on treated nails.
- Wear breathable footwear and keep feet dry to prevent reinfection.
- Do not share nail clippers or files.
Available Forms & Alternatives
Available Strengths:
- Ciclopirox Topical Suspension 30ml
- Ciclopirox Topical Suspension 60ml
- Ciclopirox 8% Nail Lacquer Top Soln
- Ciclopirox 0.77% Cream 90gm
- Ciclopirox 0.77% Cream 15gm
- Ciclopirox 0.77% Gel 30gm
- Ciclopirox 0.77% Gel 45gm
- Ciclopirox 0.77% Gel 100gm
- Ciclopirox 1% Shampoo 120ml
- Ciclopirox 8% Kit
- Ciclopirox 1% Shampoo 120ml
- Ciclopirox 0.77% Cream 30gm
- Ciclopirox 8% Nail Lacquer Top Soln
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected nails once daily, preferably at bedtime. Apply over the entire nail plate and 5 mm of surrounding skin. If possible, apply beneath the nail plate.
Condition-Specific Dosing:
onychomycosis:
Apply once daily for up to 48 weeks. Remove the lacquer with alcohol every 7 days to remove unadhered film and allow better penetration. Trim or file away loose nail material weekly.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established in pediatric patients under 12 years of age.
Adolescent:
Safety and efficacy not established in pediatric patients under 12 years of age. For patients 12 years and older, dosing is generally similar to adults, but consult specific guidelines.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Ciclopirox is a synthetic broad-spectrum antifungal agent that inhibits the growth of dermatophytes, yeasts, and other pathogenic fungi. Its mechanism of action is thought to involve chelation of polyvalent metal ions (e.g., Fe3+ and Al3+), which inhibits the metal-dependent enzymes responsible for the degradation of peroxides within the fungal cell. This leads to the accumulation of toxic peroxides and subsequent cell death. It also interferes with fungal cell membrane integrity and metabolic processes.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 5% systemic absorption after topical application to nails.
Tmax:
Not applicable for topical nail lacquer (minimal systemic absorption).
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not applicable (minimal systemic absorption).
ProteinBinding:
Not applicable (minimal systemic absorption).
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable for topical nail lacquer (minimal systemic absorption).
Clearance:
Not applicable (minimal systemic absorption).
ExcretionRoute:
Primarily renal for any systemically absorbed drug.
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Clinical improvement may be seen within weeks, but complete resolution of onychomycosis can take 6-12 months.
PeakEffect:
Not applicable for topical nail lacquer (gradual effect over months).
DurationOfAction:
Effect persists as long as treatment continues and for a period after discontinuation, but recurrence is common if treatment is stopped prematurely.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could be signs of a serious reaction:
Allergic reaction symptoms, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Skin irritation at the application site, including:
+ Blisters
+ Burning
+ Itching
+ Oozing
+ Redness
+ Swelling
+ Tender skin
+ Other forms of irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
* Changes in skin or fingernails
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could be signs of a serious reaction:
Allergic reaction symptoms, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Skin irritation at the application site, including:
+ Blisters
+ Burning
+ Itching
+ Oozing
+ Redness
+ Swelling
+ Tender skin
+ Other forms of irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
* Changes in skin or fingernails
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or irritation around the treated nail
- Worsening of the nail infection despite consistent use
- Signs of allergic reaction (e.g., rash, swelling, severe itching)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Do not initiate, discontinue, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Do not initiate, discontinue, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or products on your skin, such as soaps, consult with your doctor to ensure safe use.
Please note that the treated nail may not completely clear up with the use of this medication. Additionally, this medication is flammable, so it is crucial to keep it away from open flames and not to use it while smoking.
If this medication is accidentally swallowed, it can be harmful, and you should immediately call a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use and how it may affect you and your baby.
Please note that the treated nail may not completely clear up with the use of this medication. Additionally, this medication is flammable, so it is crucial to keep it away from open flames and not to use it while smoking.
If this medication is accidentally swallowed, it can be harmful, and you should immediately call a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use and how it may affect you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely due to minimal absorption.
What to Do:
If accidentally ingested, seek medical attention. For topical irritation, discontinue use and wash the area. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of Onychomycosis
Rationale: Confirm fungal infection before initiating treatment.
Timing: Prior to treatment initiation
Assessment of Nail Condition
Rationale: Document baseline severity and extent of infection.
Timing: Prior to treatment initiation
Routine Monitoring
Clinical Improvement of Nail
Frequency: Monthly or every 2-3 months
Target: Reduction in discoloration, thickening, and debris; clear nail growth.
Action Threshold: Lack of improvement after 6 months may warrant re-evaluation or alternative therapy.
Local Adverse Reactions (e.g., irritation, redness)
Frequency: At each follow-up visit
Target: Absence of significant irritation.
Action Threshold: Persistent or severe irritation may require temporary discontinuation or re-evaluation.
Symptom Monitoring
- Improvement in nail appearance (less discoloration, less thickening)
- New, clear nail growth
- Reduction in nail brittleness or crumbling
- Absence of local irritation, redness, or itching around the nail
Special Patient Groups
Pregnancy
Ciclopirox is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, and systemic absorption in humans is minimal. Use during pregnancy should only be if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Ciclopirox is classified as Lactation Risk L3 (Moderately Safe). It is not known if ciclopirox is excreted in human milk. Due to minimal systemic absorption, risk to the infant is considered low. Use with caution and monitor the infant for adverse effects.
Infant Risk:
Low
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age. For adolescents 12 years and older, dosing is generally similar to adults, but clinical judgment is advised.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. The minimal systemic absorption makes age-related changes in renal or hepatic function unlikely to affect drug exposure or safety.
Clinical Information
Clinical Pearls
- Ciclopirox nail lacquer requires consistent, long-term application (up to 48 weeks) for optimal results due to the slow growth of nails.
- Weekly removal of the old lacquer layer with alcohol is crucial for effective penetration of new applications.
- Regular debridement (trimming/filing) of the infected nail material enhances treatment efficacy.
- This treatment is most effective for mild to moderate onychomycosis without lunula (nail matrix) involvement.
- Patients should be advised that complete cure is not guaranteed, and recurrence is possible.
Alternative Therapies
- Efinaconazole topical solution (Jublia)
- Tavaborole topical solution (Kerydin)
- Terbinafine oral (Lamisil)
- Itraconazole oral (Sporanox)
- Griseofulvin oral
Cost & Coverage
Average Cost:
$100 - $300 per 6.6 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred brand/non-preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.