Ketoconazole 2% Foam 50gm
It is used to control seborrheic dermatitis.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category C
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketoconazole foam is a medicine applied to the skin to treat fungal infections, such as seborrheic dermatitis. It works by stopping the growth of the fungus.
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. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, eyes, or vagina, as it may cause burning.
Application Instructions
1. Wash your hands before and after applying the medication, unless your hand is the treated area.
2. Clean the affected area before use and dry it thoroughly.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. Do not cover the treated area with bandages or dressings unless your doctor advises you to do so.
5. If your skin is broken or swollen, consult your doctor before using this medication, as some medications are not suitable for use on damaged skin.
Special Instructions for Foam Application
1. Hold the can upright when using the medication.
2. Do not turn the can upside down.
3. Dispense the foam into the can's cap or onto a cool surface, rather than directly into your hands, as it may melt.
4. Use your fingertips to pick up a small amount of foam and gently rub it into the affected area until the foam is no longer visible.
5. If the affected area has hair, part the hair to apply the foam directly to the skin, rather than the hair.
Storage and Disposal
Store this medication at room temperature, away from heat, open flames, and moisture. Do not refrigerate or freeze the medication, and keep it out of the bathroom.
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 dose, skip the missed dose and resume your regular 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. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, eyes, or vagina, as it may cause burning.
Application Instructions
1. Wash your hands before and after applying the medication, unless your hand is the treated area.
2. Clean the affected area before use and dry it thoroughly.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. Do not cover the treated area with bandages or dressings unless your doctor advises you to do so.
5. If your skin is broken or swollen, consult your doctor before using this medication, as some medications are not suitable for use on damaged skin.
Special Instructions for Foam Application
1. Hold the can upright when using the medication.
2. Do not turn the can upside down.
3. Dispense the foam into the can's cap or onto a cool surface, rather than directly into your hands, as it may melt.
4. Use your fingertips to pick up a small amount of foam and gently rub it into the affected area until the foam is no longer visible.
5. If the affected area has hair, part the hair to apply the foam directly to the skin, rather than the hair.
Storage and Disposal
Store this medication at room temperature, away from heat, open flames, and moisture. Do not refrigerate or freeze the medication, and keep it out of the bathroom.
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 dose, skip the missed dose and resume your regular schedule. Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the foam.
- Shake the can well before each use.
- Apply a small amount of foam to the affected skin area and gently rub it in until it disappears.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use occlusive dressings (airtight bandages) over the treated area unless directed by your doctor.
- Complete the full course of treatment as prescribed, even if symptoms improve, to prevent recurrence.
- This product is flammable; avoid fire, flame, or smoking during and immediately after application.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area once daily for 2 to 4 weeks
Condition-Specific Dosing:
seborrheicDermatitis:
Apply to affected area once daily for 2 to 4 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established for children under 12 years of age
Adolescent:
Safety and efficacy not established for children under 12 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
Ketoconazole is an imidazole antifungal that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. It does this by inhibiting cytochrome P450-dependent 14-alpha-demethylase, which is necessary for the conversion of lanosterol to ergosterol. This inhibition leads to increased cell membrane permeability, leakage of cellular contents, and ultimately, fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic absorption from topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical formulation)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical improvement
PeakEffect:
Typically within 2-4 weeks of consistent use
DurationOfAction:
Maintained as long as treatment continues; recurrence possible after cessation if underlying condition persists
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
- A rash on the treated area if it is exposed to the sun.
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:
- Burning sensations
- Irritation at the site where the drug was applied
These are not the only possible side effects. If you have questions or concerns about side effects, consult 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 online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
- A rash on the treated area if it is exposed to the sun.
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:
- Burning sensations
- Irritation at the site where the drug was applied
These are not the only possible side effects. If you have questions or concerns about side effects, consult 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 online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or irritation at the application site
- New or worsening rash
- Signs of an allergic reaction (e.g., swelling of face/lips/tongue, severe itching, difficulty breathing)
- Lack of improvement or worsening of the skin condition after several weeks of treatment
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.
* 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 dosage 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.
* 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 dosage 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, including soaps, consult with your doctor to ensure safe use.
If you accidentally swallow this medication, immediately contact a doctor or a poison control center, as it can cause harm. Additionally, be aware that this medication is flammable and should not be used near an open flame or while smoking.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks with your doctor to make an informed decision. While breastfeeding, avoid applying this medication directly to the nipple or the surrounding area to prevent any potential harm to your baby.
If you accidentally swallow this medication, immediately contact a doctor or a poison control center, as it can cause harm. Additionally, be aware that this medication is flammable and should not be used near an open flame or while smoking.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks with your doctor to make an informed decision. While breastfeeding, avoid applying this medication directly to the nipple or the surrounding area to prevent any potential harm to 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 1-800-222-1222 (Poison Control Center).
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of affected skin area
Rationale: To establish baseline severity and extent of fungal infection/seborrheic dermatitis
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., scaling, erythema, pruritus)
Frequency: Weekly or as clinically indicated
Target: Improvement or resolution
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment
Local skin reactions (e.g., burning, stinging, irritation, dryness)
Frequency: Daily, during application
Target: Minimal to none
Action Threshold: Severe or persistent reactions may warrant discontinuation or dose adjustment
Symptom Monitoring
- Burning sensation
- Stinging sensation
- Itching (pruritus)
- Erythema (redness)
- Dry skin
- Application site reactions
- Folliculitis
- Hair discoloration (rare)
Special Patient Groups
Pregnancy
Ketoconazole foam is classified as Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption from topical application is minimal, which reduces the risk compared to oral ketoconazole.
Trimester-Specific Risks:
First Trimester:
Potential risk cannot be ruled out; minimal systemic absorption may limit risk.
Second Trimester:
Potential risk cannot be ruled out; minimal systemic absorption may limit risk.
Third Trimester:
Potential risk cannot be ruled out; minimal systemic absorption may limit risk.
Lactation
It is not known whether ketoconazole is excreted in human milk following topical application. Due to minimal systemic absorption, the risk to a nursing infant is considered low. Caution should be exercised, and the foam should not be applied to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in children should be under strict medical supervision.
Geriatric Use
No specific dose 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, age-related pharmacokinetic differences are not expected to be clinically significant.
Clinical Information
Clinical Pearls
- Ketoconazole foam is for external use only. Do not ingest.
- Shake the can vigorously before each use.
- Hold the can upright and dispense a small amount of foam into the cap or onto a cool surface (not directly onto hands, as it will melt on contact with warm skin).
- Apply the foam to dry skin.
- Avoid contact with eyes, mouth, and other mucous membranes. Rinse thoroughly with water if accidental contact occurs.
- This product is flammable. Keep away from heat, open flame, and do not smoke during or immediately after application.
- Patients should be advised to complete the full course of therapy, even if symptoms improve, to prevent relapse.
- If no improvement is seen after 4 weeks of treatment, the diagnosis should be re-evaluated.
Alternative Therapies
- Other topical antifungals (e.g., ciclopirox, econazole, miconazole, terbinafine)
- Topical corticosteroids (for inflammation, often used in combination or sequentially for seborrheic dermatitis)
- Other formulations of ketoconazole (e.g., cream, gel, shampoo)
Cost & Coverage
Average Cost:
$100 - $500+ per 50gm foam
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (varies by insurance plan)
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 your 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 information about the medication taken, the amount, and the time it happened.