Ciclopirox 0.77% Gel 30gm
It is used to treat fungal infections of the skin.It is used to control seborrheic dermatitis.
Drug Class
Antifungal
Pharmacologic Class
Hydroxypyridone Antifungal
Pregnancy Category
Category B
FDA Approved
Dec 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciclopirox gel is a topical medication used to treat seborrheic dermatitis, a common skin condition that causes red, itchy, and flaky patches, often on the scalp. It works by stopping the growth of the fungus that contributes to this condition.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as directed, even if your symptoms improve.
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 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.
Storing and Disposing of Your Medication
Store the medication at room temperature.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them 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 medications, and consider participating in a drug take-back program in your area.
What to Do If You Miss a 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 extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as directed, even if your symptoms improve.
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 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.
Storing and Disposing of Your Medication
Store the medication at room temperature.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them 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 medications, and consider participating in a drug take-back program in your area.
What to Do If You Miss a 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 extra doses to make up for a missed dose.
Lifestyle & Tips
- For external use only. Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Wash hands before and after applying the gel.
- Do not use occlusive dressings or bandages over the treated area unless directed by a healthcare professional.
- Avoid using cosmetics or other topical products on the treated area unless advised by your doctor.
- If irritation or sensitivity develops, discontinue use and consult your doctor.
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 twice daily to affected areas of the scalp and adjacent skin.
Condition-Specific Dosing:
seborrheicDermatitis:
Apply twice daily to affected areas of the scalp and adjacent skin for up to 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness in pediatric patients below the age of 16 years have not been established).
Adolescent:
Not established (Safety and effectiveness in pediatric patients below the age of 16 years have not been established).
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 pathogenic dermatophytes, yeasts, and Malassezia furfur. Its mechanism of action involves chelation of polyvalent cations (Fe3+ and Al3+), which inhibits the metal-dependent enzymes responsible for the degradation of peroxides, leading to the accumulation of toxic reactive oxygen species. It also interferes with fungal cell membrane integrity and inhibits DNA, RNA, and protein synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic absorption after topical application)
Tmax:
Not clinically relevant for systemic effects (topical application)
FoodEffect:
Not applicable (topical application)
Distribution:
Vd:
Not clinically relevant (primarily localized to skin)
ProteinBinding:
Not clinically relevant (primarily localized to skin)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant (minimal systemic absorption)
Clearance:
Not clinically relevant (minimal systemic absorption)
ExcretionRoute:
Renal (if systemically absorbed, primarily as glucuronide conjugates)
Unchanged:
Not clinically relevant (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 1-2 weeks, full effect may take up to 4 weeks.
PeakEffect:
Not applicable (topical agent, gradual effect)
DurationOfAction:
Not applicable (requires continued application for effect)
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 indicate a serious allergic reaction:
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
Additionally, if you experience any of the following skin reactions at the application site, seek medical help right away:
Blisters
Burning
Itching
Oozing
Redness
Swelling
Tender skin
* Other signs of irritation
Other Possible Side Effects
As with any medication, side effects can occur. Although many people may not experience any side effects or only minor ones, it's essential to monitor your response to the medication. If you notice any side effects that bother you or persist, contact your doctor for guidance.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor can also provide medical advice and guidance on managing side effects.
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 indicate a serious allergic reaction:
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
Additionally, if you experience any of the following skin reactions at the application site, seek medical help right away:
Blisters
Burning
Itching
Oozing
Redness
Swelling
Tender skin
* Other signs of irritation
Other Possible Side Effects
As with any medication, side effects can occur. Although many people may not experience any side effects or only minor ones, it's essential to monitor your response to the medication. If you notice any side effects that bother you or persist, contact your doctor for guidance.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor can also provide medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe burning
- Itching
- Redness
- Stinging
- Swelling
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing)
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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as these may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as these may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 poison control center immediately. If you are pregnant, planning to become pregnant, or are breast-feeding, 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:
- Overdose with topical application is highly unlikely due to minimal systemic absorption. Excessive application may lead to increased local irritation.
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222). For severe local irritation, discontinue use and wash the area with water.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (affected areas)
Rationale: To assess the severity of seborrheic dermatitis and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin reactions (e.g., irritation, burning, itching, redness)
Frequency: Daily, or as symptoms occur
Target: Absence or mild, tolerable reactions
Action Threshold: Discontinue if severe irritation or sensitization occurs.
Clinical improvement of seborrheic dermatitis symptoms
Frequency: Weekly during treatment period
Target: Reduction in scaling, erythema, and pruritus
Action Threshold: Re-evaluate diagnosis if no improvement after 4 weeks.
Symptom Monitoring
- Redness
- Itching
- Burning sensation
- Stinging
- Scaling
- Crusting
- Folliculitis
Special Patient Groups
Pregnancy
Ciclopirox is classified as Pregnancy Category B. Animal studies have shown no evidence of harm to the fetus. Due to minimal systemic absorption after topical application, the risk to a pregnant woman or 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 classified as L3 (Moderately Safe) for 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 negligible, and adverse effects on the breastfed infant are unlikely. Caution should be exercised, and direct application to the breast area should be avoided to prevent infant ingestion.
Infant Risk:
Low risk (unlikely to cause adverse effects due to minimal systemic absorption).
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 16 years have not been established. Use in this population should be based on a careful risk-benefit assessment by a healthcare professional.
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 gel is for topical use only and should not be used orally, intravaginally, or ophthalmically.
- Patients should be advised to avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
- Treatment duration for seborrheic dermatitis is typically up to 4 weeks. If no improvement is seen after this period, the diagnosis should be re-evaluated.
- Some patients may experience temporary stinging or burning upon application, which usually subsides with continued use.
- Ensure the affected areas are clean and dry before application for optimal efficacy.
Alternative Therapies
- Ketoconazole topical (cream, gel, shampoo)
- Selenium sulfide shampoo
- Zinc pyrithione shampoo
- Topical corticosteroids (e.g., desonide, hydrocortisone) for inflammation
- Calcineurin inhibitors (e.g., pimecrolimus, tacrolimus topical) (off-label for seborrheic dermatitis)
Cost & Coverage
Average Cost:
Varies, typically $50-$200+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1-3 (depending on specific insurance plan and formulary)
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 check 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.