Ketodan 2% Foam 100gm
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?
Ketodan 2% Foam is a medicine applied to the skin to treat a common skin condition called seborrheic dermatitis, which causes flaky, itchy, and red skin, often on the scalp, face, or chest. 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. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. 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 applying the medication 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 instructs 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 Handling Instructions
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 once 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. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. 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 applying the medication 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 instructs 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 Handling Instructions
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 once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Shake the foam can well before each use.
- Apply the foam to dry skin on the affected areas once daily for 2 weeks, or as directed by your doctor.
- Wash your hands before and after applying the foam.
- Avoid getting the foam in your eyes, nose, mouth, or other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use on open wounds or broken skin.
- Do not use more often or for longer than prescribed, as this will not make it work faster and may increase side effects.
- Keep the can away from heat, open flame, and direct sunlight, and do not puncture or incinerate the can.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area(s) once daily for 2 weeks.
Condition-Specific Dosing:
seborrheicDermatitis:
Apply to affected area(s) once daily for 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
Safety and efficacy established for patients 12 years of age and older: Apply to affected area(s) once daily for 2 weeks.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Ketoconazole inhibits the cytochrome P450-dependent 14-alpha-demethylation of lanosterol, an essential step in fungal ergosterol biosynthesis. This leads to an alteration of the fungal cell membrane permeability and subsequent inhibition of fungal growth.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<1 ng/mL plasma concentrations)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
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:
Within days to weeks for symptomatic improvement
PeakEffect:
Within 2 weeks of daily application
DurationOfAction:
Variable, depends on the underlying condition and continued treatment if necessary
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, or swelling of the mouth, face, lips, tongue, or throat
- Rash on the treated area if exposed to sunlight
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
- Irritation at the site where the medication was applied
These are not all the possible side effects that may occur. 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.
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, or swelling of the mouth, face, lips, tongue, or throat
- Rash on the treated area if exposed to sunlight
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
- Irritation at the site where the medication was applied
These are not all the possible side effects that may occur. 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:
- Increased redness, itching, burning, or irritation at the application site (may indicate sensitivity or worsening condition)
- Signs of an allergic reaction (e.g., rash, hives, swelling of the face/lips/tongue/throat, difficulty breathing)
- Folliculitis (inflammation of hair follicles)
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 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 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 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 this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center for assistance.
This medication is flammable, so it's crucial to exercise caution when using it. Avoid using it near open flames or while smoking, as this can pose a fire hazard.
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 ensure the best outcome for you and your baby.
When breastfeeding, apply this medication carefully, avoiding direct application to the nipple or the surrounding area to prevent any potential harm to 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.
This medication is flammable, so it's crucial to exercise caution when using it. Avoid using it near open flames or while smoking, as this can pose a fire hazard.
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 ensure the best outcome for you and your baby.
When breastfeeding, apply this medication carefully, avoiding direct application to the nipple or the surrounding area to prevent any potential harm to your baby.
Overdose Information
Overdose Symptoms:
- Overdose with topical ketoconazole foam is highly unlikely due to minimal systemic absorption. Excessive application may lead to increased local irritation.
What to Do:
If accidental ingestion occurs, contact a poison control center or seek medical attention. For severe local irritation, discontinue use and consult a healthcare professional. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Visual assessment of affected skin area
Rationale: To establish baseline severity of seborrheic dermatitis (e.g., erythema, scaling, pruritus).
Timing: Prior to initiation of treatment
Routine Monitoring
Clinical response (resolution of symptoms)
Frequency: Periodically during treatment (e.g., at 2-week follow-up)
Target: Reduction or resolution of erythema, scaling, and pruritus.
Action Threshold: If no improvement or worsening after 2 weeks, re-evaluate diagnosis and treatment.
Local adverse reactions
Frequency: Daily, during application
Target: Absence or minimal local irritation.
Action Threshold: Discontinue if severe irritation, sensitization, or allergic reaction occurs.
Symptom Monitoring
- Application site reactions (e.g., burning, stinging, pruritus, erythema, dryness, folliculitis)
- Signs of allergic reaction (e.g., rash, hives, swelling, difficulty breathing)
Special Patient Groups
Pregnancy
Ketoconazole topical is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption following topical application is minimal.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption, unlikely to pose significant risk.
Second Trimester:
Minimal systemic absorption, unlikely to pose significant risk.
Third Trimester:
Minimal systemic absorption, unlikely to pose significant risk.
Lactation
It is not known whether topical ketoconazole is excreted in human milk. However, due to minimal systemic absorption, it is considered to have a low risk to the nursing infant. Use with caution.
Infant Risk:
Low risk (L3) due to minimal systemic absorption. Consider applying after feeding and avoiding application to areas that may come into direct contact with the infant.
Pediatric Use
Safety and efficacy have been established in pediatric patients 12 years of age and older. Safety and efficacy in pediatric patients younger than 12 years of age have not been established.
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, no overall differences in safety or effectiveness have been observed.
Clinical Information
Clinical Pearls
- Ketodan foam is specifically formulated for seborrheic dermatitis and may be easier to apply to hairy areas like the scalp compared to creams or gels.
- Patients should be instructed to shake the can well before each use and to apply a thin layer to the affected area.
- Advise patients that improvement may be seen within the first week, but the full 2-week course should be completed unless otherwise directed by a healthcare provider.
- Warn patients about the flammability of the product; avoid fire, flame, or smoking during and immediately after application.
Alternative Therapies
- Other topical antifungals (e.g., ciclopirox topical, selenium sulfide shampoo, zinc pyrithione shampoo)
- Topical corticosteroids (for inflammation and itching, often used in combination or sequentially)
- Calcineurin inhibitors (e.g., pimecrolimus cream, tacrolimus ointment - off-label for seborrheic dermatitis)
- Oral antifungals (e.g., oral ketoconazole, fluconazole - reserved for severe, recalcitrant cases due to systemic side effects)
Cost & Coverage
Average Cost:
Variable, typically $100-$500+ per 100gm can
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization for brand)
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 details. 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.