Extina 2% Foam 50gm
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?
Extina 2% Foam is a medication used on the skin to treat a condition called seborrheic dermatitis. This condition causes red, flaky, and itchy patches, often on the scalp, face, or chest. The foam contains an antifungal medicine that helps stop the growth of the yeast that contributes to this skin problem.
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 area being treated.
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. Unless directed by your doctor, do not cover the treated area with bandages or dressings.
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 scheduled dose, skip the missed dose and resume your regular application 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 area being treated.
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. Unless directed by your doctor, do not cover the treated area with bandages or dressings.
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 scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- For external use only. Do not ingest.
- Shake the can well before each use.
- Apply a small amount of foam to the affected skin area(s) once daily.
- Gently massage the foam into the skin until it disappears.
- Wash your hands thoroughly after applying the foam.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Keep away from open flames or heat sources as the foam is flammable.
- Do not use more often or for longer than prescribed by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
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 patients under 12 years of age.
Adolescent:
Safety and efficacy not established for patients 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 agent that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This inhibition leads to increased membrane permeability and leakage of cellular contents, ultimately resulting in fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<1%) after topical application.
Tmax:
Not clinically relevant for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application.
ProteinBinding:
Not clinically relevant for topical application.
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant for topical application.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Not clinically relevant for topical application.
Unchanged:
Not clinically relevant for topical application.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 2 weeks of treatment.
PeakEffect:
After 2 weeks of daily application.
DurationOfAction:
Effect persists as long as treatment is continued; seborrheic dermatitis is a chronic condition that may require ongoing management.
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
- 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 application site
These are not all the 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.
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
- 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 application site
These are not all the 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:
- Increased redness, itching, burning, or irritation at the application site.
- Signs of an allergic reaction, such as rash, hives, swelling of the face or tongue, or difficulty breathing (seek immediate medical attention).
- Worsening of your skin condition despite 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 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 using 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 is 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, 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 is 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, 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to increased local irritation.
What to Do:
If swallowed, 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
Baseline Monitoring
Clinical assessment of affected skin area
Rationale: To establish baseline severity of seborrheic dermatitis and identify any pre-existing skin conditions or contraindications.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical assessment of affected skin area
Frequency: Periodically during treatment (e.g., at 2-week follow-up).
Target: Reduction in erythema, scaling, and pruritus.
Action Threshold: If no improvement or worsening of symptoms, re-evaluate diagnosis and treatment plan.
Local adverse reactions (e.g., burning, stinging, itching, erythema, dryness)
Frequency: Daily, by patient self-monitoring; periodically by clinician.
Target: Absence or mildness of reactions.
Action Threshold: Discontinue use if severe irritation, sensitization, or allergic reaction occurs.
Symptom Monitoring
- Burning sensation
- Stinging sensation
- Itching
- Erythema (redness)
- Dryness
- Application site reactions
- Hair discoloration (rare)
Special Patient Groups
Pregnancy
Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption after topical application is minimal.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data, but minimal systemic exposure from topical use reduces concern.
Second Trimester:
Potential risk based on animal data, but minimal systemic exposure from topical use reduces concern.
Third Trimester:
Potential risk based on animal data, but minimal systemic exposure from topical use reduces concern.
Lactation
Lactation Risk L3 (Moderately safe). It is not known whether topical ketoconazole is excreted in human milk. Due to minimal systemic absorption, excretion into breast milk is expected to be low. Caution should be exercised when administered to a nursing woman. Avoid applying to areas that may come into direct contact with the infant during breastfeeding.
Infant Risk:
Low risk due to minimal systemic absorption by the mother. Monitor infant for potential adverse effects such as rash or gastrointestinal upset, though unlikely.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in children should be under medical supervision and only if clearly indicated.
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 between elderly and younger patients.
Clinical Information
Clinical Pearls
- Extina foam is specifically formulated for seborrheic dermatitis and should be shaken well before each use.
- Patients should be advised that seborrheic dermatitis is a chronic condition and may recur after treatment cessation.
- The foam is flammable; patients should avoid fire, flame, and smoking during and immediately after application.
- Avoid using occlusive dressings or bandages over the treated area unless directed by a healthcare professional.
- If irritation or sensitization occurs, discontinue use and consult a physician.
Alternative Therapies
- Other topical antifungals (e.g., ciclopirox, selenium sulfide, pyrithione zinc shampoos)
- Topical corticosteroids (e.g., desonide, hydrocortisone) for inflammation and itching
- Topical calcineurin inhibitors (e.g., pimecrolimus, tacrolimus)
- Oral antifungals (e.g., oral ketoconazole, fluconazole) for severe or widespread cases (with caution due to systemic side effects)
- Phototherapy
Cost & Coverage
Average Cost:
Varies significantly by pharmacy and insurance plan. Typically ranges from $100-$300+ for a 50gm can. per 50gm can
Generic Available:
Yes
Insurance Coverage:
Varies; often Tier 2 or 3 for brand, Tier 1 for generic if covered.
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 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 details about the medication taken, the amount, and the time it happened.