Ciclopirox Topical Suspension 60ml
It is used to treat fungal infections of the skin.
Drug Class
Antifungal, Topical
Pharmacologic Class
Pyridone Antifungal
Pregnancy Category
Category B
FDA Approved
May 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciclopirox topical suspension is an antifungal medicine used on the skin to treat various 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. Apply this medication only to your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly, unless your hand is the area being treated. Clean the affected area before application and make sure it is completely dry.
Shake the medication well before use and apply a thin layer to the affected skin, gently rubbing it in. Unless your doctor advises otherwise, 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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 the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Apply this medication only to your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly, unless your hand is the area being treated. Clean the affected area before application and make sure it is completely dry.
Shake the medication well before use and apply a thin layer to the affected skin, gently rubbing it in. Unless your doctor advises otherwise, 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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 the missed one.
Lifestyle & Tips
- Wash hands before and after applying the medication.
- Clean and dry the affected area thoroughly before application.
- Apply a thin layer 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.
- Do not use in the vagina.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
- Wear loose-fitting clothing and breathable footwear (for foot infections).
- Practice good hygiene to prevent spread and recurrence of 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 and surrounding skin twice daily, in the morning and evening.
Condition-Specific Dosing:
Tinea (pedis, corporis, cruris):
Apply twice daily for 4 weeks.
Cutaneous Candidiasis:
Apply twice daily for 4 weeks.
Seborrheic Dermatitis:
Apply twice daily for up to 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and effectiveness in pediatric patients below the age of 10 years have not been established. For children 10 years and older, dosing is generally similar to adults.
Adolescent:
Apply to affected areas and surrounding skin twice daily, in the morning and evening.
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 specific considerations 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 pathogenic dermatophytes, yeasts, and Malassezia furfur. Its mechanism of action involves chelation of polyvalent metal ions (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 peroxides, causing oxidative damage and cell death. It also interferes with fungal cell membrane integrity and metabolic processes.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic after topical application)
Tmax:
Not clinically relevant due to minimal systemic absorption
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not clinically relevant due to minimal systemic absorption
ProteinBinding:
Not clinically relevant due to minimal systemic absorption (if absorbed, highly protein bound)
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant due to minimal systemic absorption
Clearance:
Not clinically relevant due to minimal systemic absorption
ExcretionRoute:
Not clinically relevant due to minimal systemic absorption (if absorbed, primarily renal)
Unchanged:
Not clinically relevant due to minimal systemic absorption
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks
PeakEffect:
Full therapeutic effect may take 2-4 weeks
DurationOfAction:
Duration of treatment is typically 2-4 weeks, depending on the infection
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
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
Local skin reactions at the application site, including:
+ Blisters
+ Burning
+ Itching
+ Oozing
+ Redness
+ Swelling
+ Tender skin
+ Other irritation
Other Possible Side Effects
As with all medications, side effects can occur. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience side effects that bother you or persist, contact your doctor for guidance.
Reporting 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.
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:
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
Local skin reactions at the application site, including:
+ Blisters
+ Burning
+ Itching
+ Oozing
+ Redness
+ Swelling
+ Tender skin
+ Other irritation
Other Possible Side Effects
As with all medications, side effects can occur. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience side effects that bother you or persist, contact your doctor for guidance.
Reporting 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, burning, or irritation at the application site (may indicate an allergic reaction or worsening irritation).
- Development of new skin rash or hives.
- Signs of secondary bacterial infection (e.g., pus, severe pain).
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 safely 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 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 safely 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 due to minimal systemic absorption. Excessive application may lead to increased local irritation.
What to Do:
If swallowed, seek medical attention immediately. For excessive topical application, wipe off excess medication. If severe local irritation occurs, discontinue use and consult a healthcare professional. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Routine Monitoring
Clinical assessment of infection site
Frequency: Weekly or as needed
Target: Resolution of erythema, scaling, pruritus, and other signs of infection
Action Threshold: If no improvement after 2-4 weeks, re-evaluate diagnosis or treatment plan; if worsening irritation occurs, discontinue use.
Symptom Monitoring
- Resolution of itching
- Reduction in redness (erythema)
- Decrease in scaling or flaking
- Improvement in skin appearance
- Monitoring for local irritation (burning, stinging, redness, itching, rash) which may indicate adverse reaction
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, risk to the fetus is considered low.
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 considered L3 (Moderately Safe) during lactation. It is not known whether ciclopirox is excreted in human milk. However, systemic absorption is minimal, making infant exposure unlikely. Use with caution; avoid applying to the breast area to prevent direct infant ingestion.
Infant Risk:
Low risk due to minimal maternal systemic absorption and unlikely infant exposure.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 10 years have not been established. For children 10 years and older, dosing is generally similar to adults. Use under medical supervision for younger children.
Geriatric Use
No specific dose adjustments or precautions 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 expected.
Clinical Information
Clinical Pearls
- Ciclopirox topical suspension is for external use only. Do not ingest.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use occlusive dressings unless specifically instructed by a healthcare provider.
- Patients should be advised to use the medication for the full prescribed treatment period, even if symptoms improve, to prevent recurrence of the infection.
- If no clinical improvement is seen after 4 weeks of treatment, the diagnosis should be re-evaluated.
- For seborrheic dermatitis, treatment may be continued for up to 4 weeks. If no improvement after 4 weeks, re-evaluate.
Alternative Therapies
- Azole antifungals (e.g., clotrimazole, miconazole, ketoconazole topical)
- Allylamine antifungals (e.g., terbinafine, naftifine topical)
- Polyene antifungals (e.g., nystatin topical)
- Other topical antifungals (e.g., tolnaftate, undecylenic acid)
Cost & Coverage
Average Cost:
$20 - $80 per 60ml suspension
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 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.