Ciclopirox 0.77% Gel 100gm
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 medicine applied to the skin to treat seborrheic dermatitis, a common skin condition that causes red, itchy, scaly patches, usually on the scalp, face, or chest. It works by stopping the growth of certain fungi that can contribute 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 instructed, 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 make sure it is dry.
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 use 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 instructed, 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 make sure it is dry.
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 use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash and dry affected areas before applying the gel.
- Apply a thin layer of gel to the affected skin areas twice daily, in the morning and evening.
- Gently rub the gel into the skin until it disappears.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Use the medication for the full prescribed duration, even if symptoms improve, to prevent recurrence.
- Avoid using cosmetics or other topical products on the treated area unless advised by 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 a thin layer to affected skin areas twice daily, in the morning and evening.
Condition-Specific Dosing:
seborrheicDermatitis:
Apply a thin layer to affected skin areas twice daily, in the morning and evening, for up to 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established in pediatric patients under 16 years of age.
Adolescent:
Safety and efficacy not established in pediatric patients under 16 years of age.
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 synthetic broad-spectrum antifungal agent that inhibits the growth of dermatophytes, yeasts, and other pathogenic fungi. Its mechanism of action is thought to involve chelation of polyvalent metal ions (e.g., Fe3+ and Al3+), which results in the inhibition of metal-dependent enzymes that are essential for fungal cell metabolism and growth. It also interferes with the synthesis of DNA, RNA, and protein, and disrupts the integrity of the fungal cell membrane.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic after topical application)
Tmax:
Not clinically relevant for topical application (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not clinically relevant (minimal systemic absorption)
ProteinBinding:
Not clinically relevant (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for topical application (minimal systemic absorption)
Clearance:
Not clinically relevant for topical application (minimal systemic absorption)
ExcretionRoute:
Not clinically relevant for topical application (minimal systemic absorption)
Unchanged:
Not clinically relevant for topical application (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks
PeakEffect:
Full therapeutic effect may take up to 4 weeks
DurationOfAction:
Maintained with continued application
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
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. 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
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
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. 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
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.
Seek Immediate Medical Attention If You Experience:
- Severe burning, itching, redness, or irritation at the application site
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Worsening of the skin condition
- Development of new skin problems
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 identify 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 it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 identify 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 it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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. In such cases, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to make an informed decision about its use, considering both your health and the health of your baby.
If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to make an informed decision about its use, considering both your health and the health of 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, wash the area with soap and water. For any concerning symptoms, call a poison control center (1-800-222-1222) or seek emergency medical care.
Drug Interactions
Monitoring
Routine Monitoring
Clinical improvement of seborrheic dermatitis symptoms (e.g., scaling, erythema, pruritus)
Frequency: Daily observation by patient, periodic assessment by clinician
Target: Reduction or resolution of symptoms
Action Threshold: Lack of improvement after 4 weeks, or worsening of symptoms, warrants re-evaluation.
Local skin reactions (e.g., burning, itching, redness, irritation)
Frequency: Daily observation by patient
Target: Minimal to no irritation
Action Threshold: Severe or persistent irritation, contact dermatitis, or allergic reaction warrants discontinuation and medical evaluation.
Symptom Monitoring
- Burning sensation at application site
- Itching at application site
- Redness (erythema)
- Irritation
- Scaling
- Pruritus
- Worsening of skin condition
Special Patient Groups
Pregnancy
Ciclopirox gel is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
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, the risk to a breastfed infant is considered low. Caution should be exercised when ciclopirox gel is administered to a nursing woman. Avoid applying to areas that may come into direct contact with the infant's mouth or skin.
Infant Risk:
L3 - Moderate risk; potential for minor, non-serious adverse effects or no data available. Minimal systemic absorption suggests low risk.
Pediatric Use
Safety and effectiveness in pediatric patients under 16 years of age 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 required 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 specifically formulated for seborrheic dermatitis and should be applied to clean, dry skin.
- Patients should be advised that full therapeutic effect may not be seen for up to 4 weeks.
- Emphasize the importance of completing the full course of treatment to prevent relapse, even if symptoms improve earlier.
- Advise patients to avoid contact with eyes and mucous membranes, as it can cause irritation.
- Local irritation (burning, itching) is a common side effect, but severe reactions warrant discontinuation.
Alternative Therapies
- Ketoconazole topical (cream, gel, shampoo)
- Selenium sulfide topical (shampoo)
- Zinc pyrithione topical (shampoo)
- Corticosteroid topical (e.g., desonide, hydrocortisone) for inflammation
- Calcineurin inhibitors topical (e.g., pimecrolimus, tacrolimus) off-label
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 100gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.