Ciclopirox 0.77% Gel 45gm
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
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciclopirox gel is a medicine applied to the skin to treat a skin condition called seborrheic dermatitis. It works by stopping the growth of certain fungi that can cause this condition, helping to reduce redness, scaling, and itching.
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 is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your 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 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.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature, away from children and pets.
Keep all medications in a safe place.
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 local drug take-back programs.
Missed 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 correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your 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 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.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature, away from children and pets.
Keep all medications in a safe place.
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 local drug take-back programs.
Missed 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
- Use exactly as directed by your doctor. Do not use more often or for longer than prescribed.
- For external use only. Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to open wounds or broken skin.
- Wash hands before and after applying the gel.
- Avoid using occlusive dressings or bandages over the treated area unless directed by your doctor.
- Keep the treated area clean and dry.
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, for up to 4 weeks.
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:
Not established
Adolescent:
Safety and efficacy not established for 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 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 hydroxypyridone antifungal agent that acts by inhibiting the synthesis of essential components of fungal cells (e.g., DNA, RNA, proteins) and by disrupting the integrity of the fungal cell membrane. It achieves this by chelating polyvalent metal ions (e.g., Fe3+ and Al3+), which leads to the inhibition of metal-dependent enzymes that are crucial for fungal metabolism and growth. It also interferes with the transport of amino acids into the fungal cell.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic after topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not extensively studied systemically due to low absorption; primarily localized to skin.
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Renal (for systemically absorbed portion, which is minimal)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks, full effect within 4 weeks.
PeakEffect:
Within 4 weeks of continuous use.
DurationOfAction:
Duration of effect persists as long as treatment is continued; recurrence possible after cessation if underlying condition persists.
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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, including:
+ 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 signs of skin irritation
Other Possible Side Effects
As with any medication, side effects can occur. However, many people do not experience any side effects or only have mild ones. If you have 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
If you experience any side effects, you can report them 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 offer medical advice.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, including:
+ 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 signs of skin irritation
Other Possible Side Effects
As with any medication, side effects can occur. However, many people do not experience any side effects or only have mild ones. If you have 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
If you experience any side effects, you can report them 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 offer medical advice.
Seek Immediate Medical Attention If You Experience:
- Severe burning, itching, or redness at the application site
- Worsening of skin condition
- Signs of allergic reaction (e.g., rash, hives, swelling, difficulty breathing)
- New skin irritation or infection
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) medications, 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 it is safe to take this medication 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) medications, 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 it is safe to take this medication 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, 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Local irritation, redness, and burning may be exacerbated.
What to Do:
Discontinue use and wash the area with soap and water. If irritation persists, seek medical attention. In case of accidental ingestion, contact a poison control center immediately. Call 1-800-222-1222.
Drug Interactions
Monitoring
Routine Monitoring
Clinical assessment of skin condition (e.g., erythema, scaling, pruritus)
Frequency: Periodically during treatment (e.g., weekly or bi-weekly)
Target: Reduction or resolution of symptoms of seborrheic dermatitis
Action Threshold: Lack of improvement after 4 weeks, worsening symptoms, or signs of irritation/allergic reaction
Symptom Monitoring
- Redness (erythema)
- Scaling
- Itching (pruritus)
- Burning sensation
- Stinging
- Irritation at application site
Special Patient Groups
Pregnancy
Ciclopirox is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data; human data lacking.
Second Trimester:
Low risk based on animal data; human data lacking.
Third Trimester:
Low risk based on animal data; human data lacking.
Lactation
It is not known whether ciclopirox is excreted in human milk. Due to minimal systemic absorption, the risk to a nursing infant is considered low. However, caution should be exercised when ciclopirox 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:
Low risk (L3)
Pediatric Use
Safety and effectiveness in pediatric patients under 16 years of age have not been established. Use in this population is generally not recommended unless specifically directed by a physician after careful consideration of risks and benefits.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Clinical studies of ciclopirox gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, no overall differences in safety or effectiveness have been observed between elderly and younger patients.
Clinical Information
Clinical Pearls
- Ciclopirox 0.77% Gel is specifically indicated for the topical treatment of seborrheic dermatitis, not for other fungal infections unless specified.
- Patients should be advised that treatment may take up to 4 weeks to achieve full therapeutic effect.
- If no clinical improvement is seen after 4 weeks of treatment, the diagnosis should be re-evaluated.
- Avoid using harsh soaps or irritants on the affected skin during treatment.
- Patients should be instructed to avoid contact with eyes and mucous membranes, as the gel may cause irritation.
Alternative Therapies
- Ketoconazole topical (cream, gel, shampoo)
- Selenium sulfide topical (shampoo)
- Zinc pyrithione topical (shampoo)
- Topical corticosteroids (e.g., hydrocortisone, desonide) for inflammation
- Calcineurin inhibitors (e.g., pimecrolimus, tacrolimus) for off-label use
Cost & Coverage
Average Cost:
$50 - $150 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for 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 for more information. 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.