Ciclopirox 0.77% Cream 30gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Pyridinone antifungal
Pregnancy Category
Category B
FDA Approved
Dec 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciclopirox cream is a medicine applied to the skin to treat fungal infections like athlete's foot, jock itch, ringworm, yeast infections, and seborrheic dermatitis. 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's essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after application, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature, keeping it out of 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. You can also check with your pharmacist about drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it's 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's essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after application, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature, keeping it out of 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. You can also check with your pharmacist about drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it's 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
- 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).
- Continue treatment 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:
tineaPedisCrurisCorporis:
Apply to affected areas and surrounding skin twice daily for 4 weeks
cutaneousCandidiasis:
Apply to affected areas and surrounding skin twice daily for 2-4 weeks
tineaVersicolor:
Apply to affected areas and surrounding skin twice daily for 4 weeks
seborrheicDermatitis:
Apply to affected areas twice daily for up to 4 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established for children under 10 years of age, but generally used in children âĨ10 years of age at adult doses for tinea infections. 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
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Ciclopirox is a broad-spectrum antifungal agent that inhibits the growth of dermatophytes, yeasts, and other pathogenic fungi. Its mechanism of action involves chelating polyvalent metal ions (e.g., Fe3+, Al3+), which inhibits metal-dependent enzymes essential for fungal metabolism and growth. It also disrupts the integrity of the fungal cell membrane, leading to leakage of intracellular components and inhibition of macromolecular synthesis (DNA, RNA, protein).
Pharmacokinetics
Absorption:
Bioavailability:
Less than 1.5% (systemic after topical application)
Tmax:
Not applicable (topical, minimal systemic absorption)
FoodEffect:
Not applicable
Distribution:
Vd:
Not available (minimal systemic absorption)
ProteinBinding:
Not available (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
1.7 hours (systemic, if absorbed)
Clearance:
Not available
ExcretionRoute:
Renal (systemic, if absorbed)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks
PeakEffect:
Full therapeutic effect usually after 2-4 weeks of treatment
DurationOfAction:
Maintained as long as treatment continues; recurrence possible 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:
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 forms of irritation
Other Possible Side Effects
As with all medications, side effects can occur. However, many people do not experience any side effects or only have mild ones. If you notice any side effects that bother you or persist, contact your doctor for guidance. This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact 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:
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 forms of irritation
Other Possible Side Effects
As with all medications, side effects can occur. However, many people do not experience any side effects or only have mild ones. If you notice any side effects that bother you or persist, contact your doctor for guidance. This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact 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 or irritation at the application site
- Severe burning or stinging
- Swelling or blistering
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose 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, seek immediate medical attention by calling a doctor or a poison control center. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor 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. Local irritation may occur.
What to Do:
If accidentally ingested, seek medical attention. For severe local irritation, discontinue use and wash the area. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Routine Monitoring
Clinical improvement of fungal infection (e.g., reduction in redness, scaling, itching)
Frequency: Daily by patient, weekly by clinician if needed
Target: Resolution of symptoms
Action Threshold: Lack of improvement after 2-4 weeks of treatment, or worsening symptoms, warrants re-evaluation and alternative diagnosis/treatment.
Local adverse reactions (e.g., burning, itching, redness, irritation)
Frequency: Daily by patient
Target: Minimal to no irritation
Action Threshold: Severe or persistent irritation, contact dermatitis, or allergic reaction requires discontinuation.
Symptom Monitoring
- Redness
- Itching
- Scaling
- Burning sensation
- Irritation
- Blistering
- Peeling
Special Patient Groups
Pregnancy
Ciclopirox cream is Pregnancy Category B. Animal studies have not shown harm to the fetus, and 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
Ciclopirox is considered L3 (moderately safe) during lactation. Due to minimal systemic absorption, excretion into breast milk is expected to be negligible. Caution should be exercised, and direct application to the breast area should be avoided to prevent infant ingestion.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption by the mother.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 10 years have not been established. Use in children 10 years and older is generally considered safe for approved indications, following adult dosing guidelines.
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, due to minimal systemic absorption, no age-related differences in safety or efficacy are anticipated.
Clinical Information
Clinical Pearls
- Ciclopirox cream is effective for a wide range of superficial fungal infections, including those caused by dermatophytes and Candida species.
- It is also one of the few topical antifungals effective for seborrheic dermatitis.
- Patients should be advised to complete the full course of treatment, even if symptoms improve, to prevent relapse.
- For intertriginous areas, ensure the skin is thoroughly dry before application to prevent maceration and enhance drug efficacy.
- Minimal systemic absorption makes it a safe option with few drug interactions.
Alternative Therapies
- Clotrimazole cream
- Miconazole cream
- Terbinafine cream
- Ketoconazole cream
- Econazole cream
- Naftifine cream
Cost & Coverage
Average Cost:
$20 - $60 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.