Ciclopirox 1% Shampoo 120ml
It is used to control seborrheic dermatitis.
Drug Class
Antifungal
Pharmacologic Class
Hydroxypyridone antifungal
Pregnancy Category
Category B
FDA Approved
Jan 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ciclopirox shampoo is a medicine used on the scalp to treat a skin condition called seborrheic dermatitis, which causes flaky, itchy, and red skin. It works by stopping the growth of the fungus that can contribute 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. Do not take this medication by mouth. It is for use on your scalp and hair only. Avoid getting it in your mouth, nose, ears, and eyes, as it may cause burning.
Apply the medication as directed, even if your symptoms improve. To do so:
1. Wet your hair and scalp.
2. Apply enough shampoo to create a lather.
3. Lather well and leave it on for 3 minutes.
4. Rinse thoroughly.
Use this medication twice a week, with at least 3 days between each application. After completing the treatment, discard any remaining medication.
Storage and Disposal
Store this medication at room temperature, in a safe location, out of the 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 scheduled 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 use this medication correctly, follow your doctor's instructions and read all the information provided. Do not take this medication by mouth. It is for use on your scalp and hair only. Avoid getting it in your mouth, nose, ears, and eyes, as it may cause burning.
Apply the medication as directed, even if your symptoms improve. To do so:
1. Wet your hair and scalp.
2. Apply enough shampoo to create a lather.
3. Lather well and leave it on for 3 minutes.
4. Rinse thoroughly.
Use this medication twice a week, with at least 3 days between each application. After completing the treatment, discard any remaining medication.
Storage and Disposal
Store this medication at room temperature, in a safe location, out of the 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 scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Use the shampoo exactly as directed by your doctor or the product label. Do not use more often or for longer than prescribed.
- Wet hair and scalp thoroughly. Apply the shampoo to affected areas, lather well, and leave on for 3 minutes before rinsing.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on other body areas unless directed by a healthcare professional.
- Consistency is key for effective treatment. Continue using for the full prescribed duration, even if symptoms improve.
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 scalp areas twice weekly for 4 weeks, with a minimum of 3 days between applications. Lather and leave on for 3 minutes before rinsing.
Condition-Specific Dosing:
seborrheicDermatitis:
Apply to affected scalp areas twice weekly for 4 weeks, with a minimum of 3 days between applications. Lather and leave on for 3 minutes before rinsing.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 16 years of age.
Adolescent:
Not established for children 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 broad-spectrum antifungal agent that inhibits the growth of dermatophytes, yeasts, and other pathogenic fungi. Its mechanism of action involves chelating polyvalent metal cations (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 amino acid uptake and cell membrane integrity, leading to disruption of cellular processes and fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic after topical application)
Tmax:
Not clinically relevant for topical use
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not clinically relevant (minimal systemic absorption)
ProteinBinding:
Not clinically relevant (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant (minimal systemic absorption)
Clearance:
Not clinically relevant (minimal systemic absorption)
ExcretionRoute:
Renal (for systemically absorbed drug)
Unchanged:
Not clinically relevant (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks (clinical improvement)
PeakEffect:
Weeks (clinical improvement)
DurationOfAction:
Maintained with continued use
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
* Change in hair color
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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, 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 attention 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
* Change in hair color
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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 scalp irritation, redness, or itching after use
- Burning or stinging sensation that is severe or persistent
- Development of a new rash or hives
- Swelling of the face, lips, or tongue (signs of allergic reaction)
- Worsening of seborrheic dermatitis symptoms
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- Allergies to other drugs, foods, or substances
- The specific signs or symptoms you experienced due to the allergy
This medication may interact with other medications or health conditions. To ensure safe use, please disclose the following to your doctor and pharmacist:
- All prescription and over-the-counter (OTC) medications you are taking
- Any natural products or vitamins you are using
- Existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- Allergies to other drugs, foods, or substances
- The specific signs or symptoms you experienced due to the allergy
This medication may interact with other medications or health conditions. To ensure safe use, please disclose the following to your doctor and pharmacist:
- All prescription and over-the-counter (OTC) medications you are taking
- Any natural products or vitamins you are using
- Existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so in conjunction with 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, seek immediate medical attention by calling a doctor or poison control center. Additionally, if you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose with topical ciclopirox shampoo is highly unlikely due to minimal systemic absorption. Excessive topical application may lead to increased local irritation.
What to Do:
If accidental ingestion occurs, seek medical attention. For excessive topical application, rinse thoroughly with water. For any concerning symptoms, call 1-800-222-1222 (Poison Control) or seek emergency medical care.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of scalp
Rationale: To determine the extent and severity of seborrheic dermatitis or fungal infection.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (reduction in scaling, itching, redness)
Frequency: Weekly during treatment period
Target: Improvement in symptoms
Action Threshold: Lack of improvement or worsening symptoms after 4 weeks may indicate need for alternative therapy or re-evaluation.
Local skin reactions (irritation, burning, itching)
Frequency: With each application
Target: Minimal to no irritation
Action Threshold: Severe or persistent irritation may require discontinuation.
Symptom Monitoring
- Scalp redness
- Scalp itching
- Scalp burning sensation
- Scaling or flaking of the scalp
- Hair loss (if associated with underlying condition)
- Signs of allergic reaction (e.g., rash, hives, swelling)
Special Patient Groups
Pregnancy
Ciclopirox 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. It should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.
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 classified as L3 (Moderately Safe) for lactation. Due to minimal systemic absorption after topical application, it is unlikely to be excreted in breast milk in clinically significant amounts. Use with caution, and consider wiping off any residue from the breast area before nursing if applied there.
Infant Risk:
Low risk of adverse effects in nursing infant due to minimal maternal systemic absorption.
Pediatric Use
Safety and effectiveness of Ciclopirox 1% Shampoo have not been established in pediatric patients under 16 years of age. 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. The systemic absorption is minimal, so age-related changes in renal or hepatic function are unlikely to affect the safety or efficacy of topical ciclopirox.
Clinical Information
Clinical Pearls
- Instruct patients to leave the shampoo on the scalp for the full 3 minutes to allow adequate contact time for the active ingredient.
- Emphasize that Ciclopirox shampoo is for external use only and to avoid contact with eyes, mouth, and other mucous membranes.
- Advise patients that improvement may not be immediate and consistent use for the full 4-week course is important for optimal results.
- Inform patients that temporary hair discoloration may occur in some cases, particularly with light-colored or chemically treated hair, though this is rare.
- If symptoms persist or worsen after the recommended treatment period, advise the patient to consult their healthcare provider for re-evaluation.
Alternative Therapies
- Ketoconazole shampoo
- Selenium sulfide shampoo
- Zinc pyrithione shampoo
- Coal tar shampoo
- Topical corticosteroids (e.g., desonide, fluocinolone)
- Topical calcineurin inhibitors (e.g., pimecrolimus, tacrolimus)
Cost & Coverage
Average Cost:
Varies, typically $20-$100 per 120ml bottle
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's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 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.