Ciclopirox Topical Suspension 30ml
It is used to treat fungal infections of the skin.
Drug Class
Antifungal, Topical
Pharmacologic Class
Pyridone Antifungal
Pregnancy Category
Category B
FDA Approved
Mar 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciclopirox topical suspension is an antifungal medicine used to treat seborrheic dermatitis, a common skin condition that causes flaky, red, and itchy patches, often on the scalp. It works by stopping the growth of the fungus that contributes to this condition.
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.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, do not wash your hand after application.
Clean the affected area before use and make sure it is completely dry.
Shake the medication well before use.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Guidelines
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Continue using the medication as directed, even if your symptoms improve.
Storage and Disposal
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 drug take-back programs 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. 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.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, do not wash your hand after application.
Clean the affected area before use and make sure it is completely dry.
Shake the medication well before use.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Guidelines
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Continue using the medication as directed, even if your symptoms improve.
Storage and Disposal
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 drug take-back programs 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
- Wash and dry the affected area before applying the medication.
- Shake the bottle well before each use.
- Apply a thin layer of the suspension to the affected areas of the scalp and adjacent skin.
- Gently massage it in.
- Do not wash the treated area for at least 8 hours after application.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Use the medication for the full prescribed duration, even if symptoms improve, to prevent recurrence.
- Maintain good scalp hygiene.
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 Ciclopirox Topical Suspension 0.77% twice daily to affected areas of the scalp and adjacent skin for 4 weeks.
Condition-Specific Dosing:
seborrheicDermatitis:
Apply twice daily to affected areas for 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for seborrheic dermatitis (safety and efficacy not established in pediatric patients under 16 years of age).
Adolescent:
Not established for seborrheic dermatitis (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 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 (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, including DNA, RNA, and protein synthesis, as well as membrane integrity.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic after topical application)
Tmax:
Not clinically significant due to minimal systemic absorption
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not clinically significant due to minimal systemic absorption
ProteinBinding:
Not clinically significant due to minimal systemic absorption
CnssPenetration:
Limited (not clinically relevant for topical use)
Elimination:
HalfLife:
Not clinically significant due to minimal systemic absorption
Clearance:
Not clinically significant due to minimal systemic absorption
ExcretionRoute:
Not clinically significant due to minimal systemic absorption
Unchanged:
Not clinically significant due to minimal systemic absorption
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks
PeakEffect:
Full therapeutic effect after 4 weeks of treatment
DurationOfAction:
Varies based on underlying condition and continued exposure to causative factors
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
If you experience any of the following severe side effects, contact your doctor or seek medical help right away, as they can be life-threatening:
- 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 forms of irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Many people have either no side effects or only minor ones. If you have side effects that bother you or do not go away, contact your doctor for advice. It's essential to remember that this list may not include all possible side effects. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or through their website at https://www.fda.gov/medwatch.
If you experience any of the following severe side effects, contact your doctor or seek medical help right away, as they can be life-threatening:
- 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 forms of irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Many people have either no side effects or only minor ones. If you have side effects that bother you or do not go away, contact your doctor for advice. It's essential to remember that this list may not include all possible side effects. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or through their website at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, itching, or irritation at the application site
- Rash or hives that spread beyond the treated area
- Swelling of the face, lips, or tongue (signs of allergic reaction)
- Worsening of the skin condition
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 it is safe to take this medication with all your other 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) 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 it is safe to take this medication with all your other 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 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:
- Unlikely with topical application due to minimal systemic absorption. Local irritation may occur if excessive amounts are applied.
What to Do:
If ingested, call a poison control center immediately (1-800-222-1222). For excessive topical application, wash the area with soap and water. Symptomatic and supportive care if needed.
Drug Interactions
Monitoring
Routine Monitoring
Clinical signs and symptoms of seborrheic dermatitis (e.g., scaling, erythema, pruritus)
Frequency: Periodically during treatment (e.g., weekly)
Target: Reduction or resolution of symptoms
Action Threshold: Lack of improvement after 4 weeks, or worsening of symptoms, indicates need for re-evaluation.
Local adverse reactions (e.g., irritation, burning, itching, redness)
Frequency: Daily, or as needed
Target: Absence or mild, tolerable reactions
Action Threshold: Severe or persistent irritation, burning, or allergic reactions require discontinuation and medical evaluation.
Symptom Monitoring
- Reduction in scaling
- Reduction in redness (erythema)
- Reduction in itching (pruritus)
- Resolution of lesions
- Development of new or worsening irritation
- Burning sensation
- Allergic reactions (rash, hives, swelling)
Special Patient Groups
Pregnancy
Ciclopirox is 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 only if clearly needed.
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
Ciclopirox is considered L3 (moderately safe) for lactation. It is not known whether ciclopirox is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be low. Caution should be exercised, and the drug should be used only if the potential benefit justifies the potential risk to the infant. Avoid applying to areas where the infant may ingest the medication.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients under 16 years of age for seborrheic dermatitis have not been established. For other indications (e.g., tinea), use in children should be based on specific product formulations and physician discretion.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. Dosage adjustments are generally not needed.
Clinical Information
Clinical Pearls
- Ciclopirox topical suspension 0.77% is specifically formulated for seborrheic dermatitis of the scalp and adjacent skin.
- Ensure patients understand the importance of shaking the bottle well before each use to ensure uniform distribution of the active ingredient.
- Advise patients to use the medication for the full 4-week course, even if symptoms improve earlier, to achieve optimal results and prevent relapse.
- Remind patients that this product is for external use only and to avoid contact with eyes and mucous membranes.
- If irritation or sensitization occurs, discontinue use and consult a healthcare professional.
Alternative Therapies
- Ketoconazole topical (shampoo, cream)
- Selenium sulfide topical (shampoo)
- Zinc pyrithione topical (shampoo)
- Corticosteroid topical (e.g., fluocinolone acetonide topical oil, desonide topical foam)
- Coal tar topical (shampoo)
Cost & Coverage
Average Cost:
$30 - $100 per 30ml bottle of 0.77% suspension
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 promptly. 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 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.