Ciclopirox 0.77% Cream 15gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal, Topical
Pharmacologic Class
Hydroxypyridone Antifungal
Pregnancy Category
Category B
FDA Approved
Dec 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciclopirox cream is an antifungal medication used to treat various skin infections caused by fungi, such as athlete's foot, jock itch, ringworm, and yeast infections of the skin. It works by stopping the growth of the fungus.
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 skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature, in a safe place, out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Check with your pharmacist for guidance on the best way to dispose of medication, and consider participating in a drug take-back program in your area.
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 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 skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature, in a safe place, out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. Check with your pharmacist for guidance on the best way to dispose of medication, and consider participating in a drug take-back program in your area.
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 dose.
Lifestyle & Tips
- Wash hands before and after applying the cream.
- Clean and dry the affected area thoroughly before application.
- Apply a thin layer of cream to the affected skin and surrounding area.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Wear loose-fitting clothing and breathable footwear (for foot infections).
- Change socks and underwear daily.
- Continue using the medication for the full prescribed duration, even if symptoms improve, to prevent recurrence.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
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 areas twice daily
Condition-Specific Dosing:
tineaPedis:
Apply for 4 weeks
tineaCorporis:
Apply for 2 weeks
tineaCruris:
Apply for 2 weeks
cutaneousCandidiasis:
Apply for 2 weeks
tineaVersicolor:
Apply for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established for children under 10 years of age, but has been used off-label. Consult physician.
Adolescent:
Apply to affected areas twice daily for 2-4 weeks, similar to adult dosing.
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 broad-spectrum antifungal agent that inhibits the growth of dermatophytes, yeasts, and Malassezia furfur. Its mechanism of action involves chelating polyvalent cations (e.g., Fe3+ and Al3+), which inhibits essential metal-dependent enzymes (e.g., succinate dehydrogenase, cytochrome P450 enzymes) responsible for fungal cellular respiration and synthesis of macromolecules (DNA, RNA, proteins, and lipids). It also disrupts the integrity of the fungal cell membrane.
Pharmacokinetics
Absorption:
Bioavailability:
<1.5% (systemic absorption after topical application)
Tmax:
Not typically relevant for topical application; peak plasma concentrations are very low and variable.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical formulation due to minimal systemic absorption.
ProteinBinding:
Not applicable for topical formulation due to minimal systemic absorption.
CnssPenetration:
No
Elimination:
HalfLife:
Not precisely determined for topical application due to minimal systemic absorption; for absorbed drug, approximately 1.7 hours.
Clearance:
Not precisely determined for topical application.
ExcretionRoute:
Renal (for systemically absorbed portion)
Unchanged:
Approximately 96% of absorbed drug is excreted renally, primarily as unchanged drug or glucuronide conjugates.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks.
PeakEffect:
Full therapeutic effect may take 2-4 weeks of continuous application.
DurationOfAction:
Effects persist as long as treatment continues; recurrence possible if treatment is stopped prematurely.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or do not go away, call your doctor for advice.
Reporting Side Effects
If you have questions or concerns about side effects, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
Remember, this is not an exhaustive list of possible side effects. If you have any questions or concerns, always consult your doctor.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or do not go away, call your doctor for advice.
Reporting Side Effects
If you have questions or concerns about side effects, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
Remember, this is not an exhaustive list of possible side effects. If you have any questions or concerns, always consult your doctor.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, burning, or irritation at the application site
- Swelling or blistering of the skin
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- No improvement in symptoms after 2-4 weeks of treatment
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, 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. If this medication is accidentally swallowed, it can be harmful, so it is crucial to contact a doctor or a poison control center immediately. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Excessive application may lead to increased local irritation.
What to Do:
If accidentally ingested, seek medical attention. For excessive topical application, wipe off excess and monitor for local irritation. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Routine Monitoring
Clinical assessment of affected skin area
Frequency: Periodically during treatment (e.g., weekly)
Target: Reduction in erythema, scaling, pruritus; clearing of lesions.
Action Threshold: Lack of improvement after 2-4 weeks, worsening symptoms, or signs of irritation/allergic reaction.
Symptom Monitoring
- Resolution of itching
- Reduction in redness
- Decrease in scaling
- Clearing of lesions
- Monitor for local irritation (burning, stinging, redness, itching) which may indicate sensitivity or adverse reaction.
Special Patient Groups
Pregnancy
Ciclopirox is Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and potential benefits outweigh potential risks.
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
It is not known whether ciclopirox is excreted in human milk. Due to minimal systemic absorption, risk to a nursing infant is considered low. Exercise caution when administering to a nursing woman. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 10 years of age. Use in children should be under medical supervision and only if potential benefits outweigh risks.
Geriatric Use
No specific dosage 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, no overall differences in safety or effectiveness have been observed.
Clinical Information
Clinical Pearls
- Ciclopirox cream is for external use only. Do not use in the eyes, mouth, or vagina.
- Ensure the affected area is clean and dry before application to maximize efficacy.
- Patients should be advised to complete the full course of therapy, even if symptoms improve, to prevent relapse.
- If no clinical improvement is seen after the recommended treatment period (e.g., 2-4 weeks), the diagnosis should be re-evaluated.
- Local adverse reactions are generally mild and transient, including itching, burning, and redness.
Alternative Therapies
- Clotrimazole cream
- Miconazole cream
- Terbinafine cream
- Ketoconazole cream
- Econazole cream
- Naftifine cream
Cost & Coverage
Average Cost:
$15 - $40 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.