Ciclopirox 8% Kit
It is used to treat fungal infections of the nails.
Drug Class
Antifungal, Topical
Pharmacologic Class
Pyridone Antifungal
Pregnancy Category
Category B
FDA Approved
Dec 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciclopirox nail solution 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 needs to be used consistently for many months to see results.
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 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 Instructions
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 dose.
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 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 Instructions
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 dose.
Lifestyle & Tips
- Trim nails regularly and keep them clean.
- Avoid wearing tight-fitting shoes that trap moisture.
- Wear breathable footwear and cotton socks.
- Avoid sharing nail clippers, files, or shoes.
- Disinfect shoes regularly.
- Do not use nail polish or artificial nails on affected nails during treatment.
- Follow application instructions carefully, including removing old lacquer weekly.
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 and immediately adjacent skin once daily, preferably at bedtime. The nail plate should be free of loose nail material. After 7 days, remove the lacquer with alcohol and remove any loose nail material. Reapply daily. This cycle is repeated throughout the duration of therapy.
Condition-Specific Dosing:
onychomycosis:
Apply once daily to affected nails and surrounding skin. Remove with alcohol after 7 days, then reapply. Continue for up to 48 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (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, adult dosing may be considered, but specific data are limited.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (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 cations (e.g., Fe3+ and Al3+), which inhibits the activity of metal-dependent enzymes essential for fungal metabolism and growth. It also interferes with fungal cell membrane integrity and transport processes.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 5% (systemic absorption after topical application to nails)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Renal (for systemically absorbed drug)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Slow (clinical improvement typically seen after several months of treatment)
PeakEffect:
Not applicable (requires prolonged treatment for full effect)
DurationOfAction:
Requires continuous application for up to 48 weeks for complete nail clearance
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble 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 irritation
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you experience any of these or any other side effects that bother you or do not go away, contact your doctor for advice:
* Changes in skin or fingernails
Reporting Side Effects
This list is not exhaustive, and you may have questions about other potential side effects. If you do, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble 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 irritation
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you experience any of these or any other side effects that bother you or do not go away, contact your doctor for advice:
* Changes in skin or fingernails
Reporting Side Effects
This list is not exhaustive, and you may have questions about other potential side effects. If you do, don't hesitate to reach out to 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:
- Severe redness, swelling, or pain around the treated nail
- Increased burning or itching that does not subside
- Signs of a new infection (e.g., pus, fever)
- Allergic reaction symptoms (e.g., rash, hives, difficulty breathing - seek immediate medical attention)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
An allergy to this medication or any of its components
An allergy to other medications, foods, or substances
The specific signs and symptoms you experienced due to the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure your safety, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
An allergy to this medication or any of its components
An allergy to other medications, foods, or substances
The specific signs and symptoms you experienced due to the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure your safety, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify 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 drug. To minimize risks, it is crucial to handle this medication with care, as it is flammable. Avoid using it near open flames or while smoking.
In case of accidental ingestion, this drug can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
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, considering both your health and the baby's well-being.
Please note that the treated nail may not completely clear up with the use of this drug. To minimize risks, it is crucial to handle this medication with care, as it is flammable. Avoid using it near open flames or while smoking.
In case of accidental ingestion, this drug can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
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, considering both your health and the baby's well-being.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. Local irritation may occur if excessive amounts are applied.
What to Do:
If ingested, call a poison control center immediately (1-800-222-1222). For excessive topical application, wash the area with soap and water.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of Onychomycosis
Rationale: Confirm fungal infection before initiating treatment.
Timing: Prior to treatment initiation
Routine Monitoring
Clinical improvement of nail
Frequency: Monthly to every 3 months
Target: Reduction in affected nail area, clearer nail growth
Action Threshold: Lack of improvement after 6-12 months may warrant re-evaluation or alternative therapy.
Local adverse reactions (e.g., redness, irritation, burning)
Frequency: At each follow-up visit
Target: Absence or mild, tolerable reactions
Action Threshold: Severe or persistent reactions may require discontinuation.
Symptom Monitoring
- Redness or irritation around the nail
- Burning or stinging sensation at the application site
- Itching
- Nail discoloration (unrelated to fungus)
- Nail shape changes (unrelated to fungus)
Special Patient Groups
Pregnancy
Ciclopirox is Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data and minimal systemic absorption.
Second Trimester:
Low risk based on animal data and minimal systemic absorption.
Third Trimester:
Low risk based on animal data and minimal systemic absorption.
Lactation
Lactation Risk L3 (Moderately Safe). It is not known whether ciclopirox is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be very low. Use with caution; consider potential benefits vs. risks.
Infant Risk:
Low risk due to minimal systemic absorption. Monitor infant for any signs of adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age. Use in this population is generally not recommended.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related pharmacokinetic changes are unlikely to be clinically significant.
Clinical Information
Clinical Pearls
- Ciclopirox nail lacquer requires consistent, long-term application (up to 48 weeks) for optimal results. Patients should be counseled on the importance of adherence.
- The treatment is for mild to moderate onychomycosis without lunula involvement. For more severe cases, oral antifungals or combination therapy may be necessary.
- Regular debridement (filing or trimming) of the affected nail is crucial for treatment success, as it allows better penetration of the medication.
- Patients should be advised that cosmetic improvement may lag behind mycological cure.
- The kit often includes nail files and alcohol wipes to facilitate proper application and removal.
Alternative Therapies
- Efinaconazole topical solution (Jublia)
- Tavaborole topical solution (Kerydin)
- Terbinafine oral (Lamisil)
- Itraconazole oral (Sporanox)
- Fluconazole oral (Diflucan)
- Amorolfine nail lacquer (not FDA approved in US)
Cost & Coverage
Average Cost:
$100 - $300 per 6.6 mL bottle of 8% solution
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (may require prior authorization for brand)
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 for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 details about the overdose, including the medication taken, the amount, and the time it occurred.