Ciclopirox 0.77% Cream 90gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Hydroxypyridone 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 various fungal infections, 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. Use this medication only as directed and continue to use it 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 applying the medication, 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.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Storage and Disposal
Store this medication at room temperature, keeping it 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 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 application 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. Use this medication only as directed and continue to use it 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 applying the medication, 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.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Storage and Disposal
Store this medication at room temperature, keeping it 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 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 application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Clean and dry the affected area thoroughly before applying the cream.
- Wash hands before and after applying the cream.
- Avoid covering the treated area with occlusive dressings unless directed by a doctor.
- Wear loose-fitting clothing and breathable footwear (for foot infections).
- Change socks and underwear daily.
- Continue using the cream for the full prescribed duration, even if symptoms improve, to prevent recurrence.
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:
Tinea pedis, tinea cruris, tinea corporis:
Apply twice daily for 4 weeks
Candidiasis:
Apply twice daily for 2 weeks
Tinea versicolor:
Apply twice daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established for children under 10 years of age for all indications. For tinea infections, generally applied twice daily for 2-4 weeks, similar to adults, if deemed appropriate by a physician.
Adolescent:
Apply to affected areas twice daily, similar to adult dosing.
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 adjustment needed (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 broad-spectrum antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Its mechanism of action is thought to involve chelation of polyvalent cations (e.g., Fe3+), which inhibits the metal-dependent enzymes responsible for the degradation of peroxides within the fungal cell. This leads to the accumulation of toxic reactive oxygen species and disruption of cellular processes. It also interferes with fungal cell membrane integrity and synthesis of DNA, RNA, and protein.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 1.3% (systemic after topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Renal (if systemically absorbed)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks
PeakEffect:
Full therapeutic effect may take 2-4 weeks of continuous application
DurationOfAction:
Duration of treatment is typically 2-4 weeks, depending on the infection type and severity.
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
+ 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 signs of skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Submit a report 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
+ 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 signs of skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Submit a report online at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Increased redness or irritation at the application site
- Severe itching or burning that was not present before or worsens
- Development of a new rash or allergic reaction
- 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health 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 change 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health 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 change 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, 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 (e.g., redness, burning, itching).
What to Do:
If excessive application occurs, wash the area with soap and water. If irritation is severe or persists, discontinue use and consult a healthcare professional. In case of accidental ingestion, contact a poison control center (1-800-222-1222) or seek medical attention immediately, though systemic toxicity from ingestion is also unlikely due to poor absorption.
Drug Interactions
Monitoring
Routine Monitoring
Clinical signs and symptoms of fungal infection (e.g., redness, itching, scaling)
Frequency: Daily by patient, periodically by healthcare provider
Target: Resolution or significant improvement of symptoms
Action Threshold: Lack of improvement after 2-4 weeks, worsening symptoms, or signs of irritation/allergic reaction
Local skin reactions (e.g., burning, itching, redness, irritation)
Frequency: Daily by patient
Target: Absence or mild, transient reactions
Action Threshold: Severe or persistent irritation, contact dermatitis
Symptom Monitoring
- Resolution of itching
- Reduction in redness and inflammation
- Clearing of skin lesions (e.g., scaling, rash)
- Absence of burning sensation
Special Patient Groups
Pregnancy
Ciclopirox 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. Due to minimal systemic absorption, the risk to the fetus is considered low. Use only 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
It is not known whether ciclopirox is excreted in human milk. However, due to minimal systemic absorption, excretion into breast milk is expected to be very low. Caution should be exercised when administered to a nursing woman. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk due to minimal systemic absorption by the mother and low likelihood of significant transfer to breast milk. Direct contact with the infant should be avoided.
Pediatric Use
Safety and effectiveness in pediatric patients under 10 years of age have not been established for all indications. For tinea infections, use in children 10 years and older is generally considered safe and effective, similar to adults. Consult a pediatrician for use in younger children.
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
- Ensure the affected skin area is clean and dry before applying the cream to maximize efficacy.
- Advise patients to use the medication for the full prescribed duration, even if symptoms improve, to prevent relapse.
- For intertriginous areas (e.g., groin, between toes), ensure the area remains as dry as possible to prevent fungal growth.
- Ciclopirox cream is for external use only; avoid contact with eyes, nose, mouth, and other mucous membranes.
- If irritation or sensitization occurs, discontinue treatment and consult a healthcare provider.
Alternative Therapies
- Clotrimazole cream
- Miconazole cream
- Terbinafine cream
- Ketoconazole cream
- Econazole cream
- Naftifine cream
Cost & Coverage
Average Cost:
$20 - $60 per 90gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 this 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 details about the overdose, including the medication taken, the amount, and the time it occurred.