Ketoconazole 2% Foam 100gm
It is used to control seborrheic dermatitis.
Drug Class
Antifungal
Pharmacologic Class
Imidazole antifungal
Pregnancy Category
Category C
FDA Approved
May 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketoconazole foam is an antifungal medicine applied to the skin to treat certain skin conditions caused by fungus, 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 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.
Using the Foam
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. Avoid placing the foam directly in your hands, as it will 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 and open flames. Keep it in a dry place, avoiding bathrooms and refrigeration or freezing.
Missed Dose
If you miss a dose, use 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 use two doses at the same time or take 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 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.
Using the Foam
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. Avoid placing the foam directly in your hands, as it will 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 and open flames. Keep it in a dry place, avoiding bathrooms and refrigeration or freezing.
Missed Dose
If you miss a dose, use 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 use two doses at the same time or take extra doses.
Lifestyle & Tips
- Shake the canister well before each use.
- Invert the canister and dispense a small amount of foam into the cap or onto a cool surface (e.g., a saucer). Do not dispense directly onto warm hands as the foam will melt.
- Gently massage the foam into the affected skin areas until it disappears.
- Wash your hands thoroughly after applying the foam.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- This product is flammable. Avoid fire, flame, or smoking during and immediately after application.
- Do not puncture or incinerate the canister. Do not expose to heat or store at temperatures above 120°F (49°C).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area twice daily for 4 weeks
Condition-Specific Dosing:
seborrheicDermatitis:
Apply to affected area twice daily for 4 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients under 12 years of age)
Adolescent:
Apply to affected area twice daily for 4 weeks (for patients 12 years and older)
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-demethylation of lanosterol, a precursor to ergosterol. This leads to increased cellular permeability and leakage of cellular contents, ultimately inhibiting fungal growth.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (plasma concentrations generally below detectable limits <5 ng/mL)
Tmax:
Not applicable (for systemic absorption, as it's minimal)
FoodEffect:
Not applicable (topical administration)
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 (clinical improvement typically seen within 4 weeks)
PeakEffect:
Not applicable (local antifungal effect)
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
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 immediately:
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
A 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing side effects.
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 immediately:
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
A 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Increased redness, swelling, or irritation at the application site
- Signs of an allergic reaction (e.g., rash, hives, severe itching, swelling of the face/lips/tongue, difficulty breathing)
- Development of new or worsening skin lesions
- Pus or signs of 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) drugs, natural products, and vitamins. This information will help your doctor 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 this medication can be taken 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 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 this medication can be taken 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, discuss the potential benefits and risks of using this medication with your doctor. This will help you make an informed decision about its use.
When breastfeeding, take care to avoid applying this medication directly 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, discuss the potential benefits and risks of using this medication with your doctor. This will help you make an informed decision about its use.
When breastfeeding, take care to avoid applying this medication directly 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. Ingestion of the foam could lead to gastrointestinal upset.
What to Do:
If accidental ingestion occurs, seek medical attention. For topical overuse, wash the area with water. For any concerning symptoms, call 1-800-222-1222 (Poison Control Center) or seek emergency medical care.
Drug Interactions
Monitoring
Routine Monitoring
Clinical signs and symptoms of seborrheic dermatitis (e.g., erythema, scaling, pruritus)
Frequency: Regularly throughout treatment (e.g., weekly or bi-weekly)
Target: Resolution or significant improvement
Action Threshold: Lack of improvement after 4 weeks, worsening symptoms, or development of new symptoms may indicate need to re-evaluate diagnosis or treatment.
Local adverse reactions (e.g., burning, stinging, pruritus, erythema, dryness, peeling)
Frequency: Regularly throughout treatment
Target: Absence or mild, tolerable reactions
Action Threshold: Severe or persistent local irritation, signs of allergic reaction (e.g., rash, hives, swelling) require discontinuation and medical evaluation.
Symptom Monitoring
- Redness
- Itching
- Burning sensation
- Stinging sensation
- Dryness
- Peeling
- Irritation
- Folliculitis
- Hair discoloration
- Skin discoloration
Special Patient Groups
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, but use with caution and only if clearly needed.
Second Trimester:
Minimal systemic absorption, but use with caution and only if clearly needed.
Third Trimester:
Minimal systemic absorption, but use with caution and only if clearly needed.
Lactation
L3 (Moderately Safe). It is not known whether topical ketoconazole is excreted in human milk. However, systemic absorption is minimal, making significant exposure to the infant unlikely. Use with caution and avoid applying to areas where the infant may ingest the medication.
Infant Risk:
Low risk of adverse effects to a breastfed infant due to minimal maternal systemic absorption.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age. Use in children should be under the guidance of a healthcare professional.
Geriatric Use
No specific dosage 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, but no overall differences in safety or effectiveness have been observed.
Clinical Information
Clinical Pearls
- Ketoconazole foam is specifically formulated for seborrheic dermatitis and should be applied to the affected areas, not just the hair.
- The foam melts quickly on contact with warm skin, so dispense it into the cap or onto a cool surface before applying.
- Patients should be advised about the flammability of the product and to avoid heat, flame, or smoking during and immediately after application.
- Treatment duration is typically 4 weeks; prolonged use should be discussed with a healthcare provider.
- Ensure patients understand proper application technique to maximize efficacy and minimize waste.
Alternative Therapies
- Other topical antifungals (e.g., ciclopirox, selenium sulfide, zinc pyrithione for seborrheic dermatitis)
- Topical corticosteroids (for inflammation associated with seborrheic dermatitis)
- Topical calcineurin inhibitors (e.g., pimecrolimus, tacrolimus)
- Oral antifungals (e.g., oral ketoconazole, fluconazole, itraconazole - typically reserved for severe, recalcitrant cases due to systemic side effects)
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/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 overdose, including the medication taken, the amount, and the time it occurred.