Extina 2% Foam 100gm
It is used to control seborrheic dermatitis.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category C
FDA Approved
Dec 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Extina 2% Foam is a medicine applied to the skin to treat a skin condition called seborrheic dermatitis, which causes flaky, itchy, 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. 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. Unless instructed 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 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, 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. Unless instructed 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 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, 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 before and after applying the foam.
- Shake the can well before use.
- Invert the can and dispense a small amount of foam into the cap or onto a cool surface (not directly onto hands as it will melt).
- Apply a thin layer of foam to the affected skin areas and gently rub it in until it disappears.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use more often or for longer than prescribed.
- Do not bandage, cover, or wrap the treated area unless directed by your doctor.
- Avoid using other topical products on the same area unless advised by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic 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 effectiveness in pediatric patients under 12 years of age have not been established).
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 due to negligible 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 permeability of the fungal cell membrane, resulting in leakage of cellular contents and ultimately cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption (plasma concentrations generally below detection limit of 1 ng/mL after topical application).
Tmax:
Not applicable for systemic Tmax due to negligible absorption.
FoodEffect:
Not applicable for 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:
Clinical improvement typically seen within 2-4 weeks.
PeakEffect:
Not precisely defined for topical effect, but full therapeutic effect expected by end of 4-week treatment.
DurationOfAction:
Effect persists 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 immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs and symptoms that may indicate a serious reaction:
- Allergic reaction symptoms, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Burning sensation
- Irritation at the site where the medication was applied
Note: This list does not include all possible 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.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs and symptoms that may indicate a serious reaction:
- Allergic reaction symptoms, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Burning sensation
- Irritation at the site where the medication was applied
Note: This list does not include all possible 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:
- Severe burning, stinging, or irritation at the application site
- Worsening of skin condition
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to assess potential interactions and determine the best course of treatment for you.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to assess potential interactions and determine the best course of treatment for you.
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 ingested, it can be harmful. In the event of accidental ingestion, 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 this medication 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 possible 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 ingested, it can be harmful. In the event of accidental ingestion, 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 this medication 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 possible 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:
- Overdose with topical ketoconazole is unlikely due to minimal systemic absorption. Excessive application may lead to increased local irritation.
What to Do:
If swallowed, seek medical attention immediately. For excessive topical application, wash the area with soap and water. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Routine Monitoring
Resolution of skin lesions (e.g., scaling, erythema, pruritus)
Frequency: Daily/Weekly by patient, at follow-up visits by clinician
Target: Improvement or resolution of symptoms
Action Threshold: Lack of improvement after 4 weeks, worsening symptoms, or significant irritation.
Local skin reactions (e.g., burning, stinging, itching, irritation, dryness)
Frequency: Daily by patient
Target: Minimal to no reaction
Action Threshold: Severe or persistent local reactions warrant discontinuation and medical evaluation.
Symptom Monitoring
- Burning sensation at application site
- Stinging sensation at application site
- Itching
- Irritation
- Dryness
- Erythema (redness)
- Pruritus (itching)
- Scaling
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is negligible, but animal studies with oral ketoconazole have shown teratogenic effects at high doses.
Trimester-Specific Risks:
First Trimester:
Category C. Risk is considered low due to minimal systemic absorption.
Second Trimester:
Category C. Risk is considered low due to minimal systemic absorption.
Third Trimester:
Category C. Risk is considered low due to minimal systemic absorption.
Lactation
It is not known whether topical ketoconazole is excreted in human milk. Due to negligible systemic absorption, excretion into breast milk is unlikely to be clinically significant. Use with caution; consider the benefits of breastfeeding and the potential risks to the infant.
Infant Risk:
Low (L3 - Moderately Safe) due to minimal systemic absorption. Advise nursing mothers to avoid applying the foam to the breast area to prevent direct infant exposure.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in adolescents (12 years and older) is generally consistent with adult dosing.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. No specific dose adjustment is required.
Clinical Information
Clinical Pearls
- Extina foam is specifically formulated for seborrheic dermatitis and may be preferred for hairy areas due to its foam consistency.
- Patients should be instructed to shake the can well and dispense the foam into the cap or onto a cool surface to prevent it from melting too quickly on warm hands.
- Treatment duration is typically 4 weeks; advise patients to complete the full course even if symptoms improve earlier.
- If no improvement is seen after 4 weeks, the diagnosis should be re-evaluated.
- Advise patients that local irritation (burning, stinging) is common but usually mild and transient.
Alternative Therapies
- Other topical antifungals (e.g., ciclopirox, selenium sulfide, zinc pyrithione)
- Topical corticosteroids (e.g., desonide, hydrocortisone) for inflammation
- Calcineurin inhibitors (e.g., pimecrolimus, tacrolimus) for anti-inflammatory effects
- Oral antifungals (e.g., oral ketoconazole, itraconazole) for severe or widespread cases (rarely used for seborrheic dermatitis due to systemic risks)
Cost & Coverage
Average Cost:
Not available Not available
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may vary by plan)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.