Epiduo 0.1-2.5% Gel (pump) 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid-like agent (Adapalene); Oxidizing agent, Antimicrobial (Benzoyl Peroxide)
Pregnancy Category
Category C
FDA Approved
Aug 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Epiduo Gel is a topical medication used to treat acne. It contains two active ingredients: Adapalene, which is a retinoid that helps to unclog pores and reduce inflammation, and Benzoyl Peroxide, which kills acne-causing bacteria and helps to dry out excess oil. It works by targeting multiple causes of acne to clear existing blemishes and prevent new ones from forming.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Do not apply the medication to the vagina or to areas with cuts, scrapes, eczema, or damaged skin.
Also, avoid applying the medication to sunburned skin.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected area before applying the medication and ensure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Precautions
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store the medication at room temperature, protecting it from heat and light.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
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 the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Do not apply the medication to the vagina or to areas with cuts, scrapes, eczema, or damaged skin.
Also, avoid applying the medication to sunburned skin.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected area before applying the medication and ensure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Precautions
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store the medication at room temperature, protecting it from heat and light.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
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 the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply to clean, dry skin once daily in the evening.
- Use a pea-sized amount for the entire face, avoiding eyes, lips, nostrils, and mucous membranes.
- Wash hands thoroughly after application.
- Avoid excessive sun exposure and use a broad-spectrum sunscreen (SPF 30 or higher) daily, as this medication can increase sun sensitivity.
- Wear protective clothing when outdoors.
- Avoid using other topical acne treatments or products that can cause skin irritation (e.g., abrasive soaps, cleansers, astringents, alcohol-containing products) unless directed by your doctor.
- This product may bleach hair or colored fabrics (towels, pillowcases, clothing); allow it to dry completely before contact with fabrics.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas of the face and trunk once daily in the evening
Condition-Specific Dosing:
initial_irritation:
Reduce frequency to every other day if severe irritation occurs, then gradually increase as tolerated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 9 years of age and older: Apply a thin layer to affected areas of the face and trunk once daily in the evening.
Adolescent:
Same as adult dosing for patients 9 years of age 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
Adapalene is a retinoid-like compound that modulates cellular differentiation, keratinization, and inflammatory processes. It binds to specific retinoic acid nuclear receptors (RARΞ² and RARΞ³), but not to the cytosolic receptor protein. It normalizes differentiation of follicular epithelial cells, resulting in decreased microcomedone formation. Benzoyl Peroxide is an oxidizing agent with bactericidal and keratolytic effects. It releases free oxygen radicals that oxidize bacterial proteins, effectively killing Cutibacterium acnes (formerly Propionibacterium acnes). It also reduces sebum production and has a mild peeling effect, helping to clear pores.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<0.25% for adapalene; <5% for benzoyl peroxide, which is converted to benzoic acid)
Tmax:
Adapalene: 3-6 hours (if detectable); Benzoyl Peroxide: Not applicable (rapidly converted)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not well characterized due to minimal systemic absorption
ProteinBinding:
Adapalene: Approximately 99% (in plasma, if absorbed); Benzoyl Peroxide: Not applicable (local metabolism)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Adapalene: Not precisely determined due to minimal systemic absorption; Benzoyl Peroxide: Not applicable (rapid local metabolism)
Clearance:
Not well characterized due to minimal systemic absorption
ExcretionRoute:
Adapalene: Primarily biliary excretion; Benzoyl Peroxide: Benzoic acid excreted renally
Unchanged:
Adapalene: Minimal; Benzoyl Peroxide: Not applicable (rapidly metabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-4 weeks; full therapeutic effect may take 8-12 weeks.
PeakEffect:
8-12 weeks
DurationOfAction:
Sustained with continued daily use
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Severe skin irritation
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 have any side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Severe skin irritation
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 have any side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (e.g., extreme redness, dryness, peeling, burning, stinging)
- Swelling of the face, lips, or tongue
- Difficulty breathing or hives (signs of an allergic reaction)
- Blistering or crusting of the skin
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Allergic Reactions and Irritation
Certain acne products, including this one, that contain benzoyl peroxide or salicylic acid can cause severe and potentially life-threatening allergic reactions or irritation in rare cases. Before using this medication for the first time, you may need to follow specific steps to ensure you do not have an allergic reaction. Be sure to use this medication as directed by your doctor or as indicated on the package label. If you have any questions or concerns, discuss them with your doctor.
Application and Skin Care
When applying this medication, exercise caution to avoid bleaching your hair or colored fabrics. You may notice that your skin appears worse before it starts to improve. Additionally, this medication can increase your sensitivity to the sun, making it easier to get sunburned. To protect your skin, avoid exposure to sunlight, sunlamps, and tanning beds, and use sunscreen and wear protective clothing and eyewear when going outside.
Weather Conditions and Skin Irritation
Certain weather conditions, such as cold and wind, can irritate your skin. Consult with your doctor or pharmacist for guidance on how to protect your skin in these conditions.
Precautions and Interactions
Do not wax the affected skin, as this can cause irritation. Using other skin products while taking this medication can increase the risk of irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe use.
Potential Side Effects
It may take several weeks to experience the full effects of this medication. If you swallow this medication, it can cause harm, so it is essential to call a doctor or poison control center immediately if this happens. Some people may experience skin reactions, such as burning, dryness, redness, scaling, or stinging, where the medication is applied. In most cases, these reactions will resolve within 4 weeks after starting the medication. However, if these reactions persist or worsen, consult with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of using this medication with your doctor to ensure the best possible outcome for you and your baby. If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Allergic Reactions and Irritation
Certain acne products, including this one, that contain benzoyl peroxide or salicylic acid can cause severe and potentially life-threatening allergic reactions or irritation in rare cases. Before using this medication for the first time, you may need to follow specific steps to ensure you do not have an allergic reaction. Be sure to use this medication as directed by your doctor or as indicated on the package label. If you have any questions or concerns, discuss them with your doctor.
Application and Skin Care
When applying this medication, exercise caution to avoid bleaching your hair or colored fabrics. You may notice that your skin appears worse before it starts to improve. Additionally, this medication can increase your sensitivity to the sun, making it easier to get sunburned. To protect your skin, avoid exposure to sunlight, sunlamps, and tanning beds, and use sunscreen and wear protective clothing and eyewear when going outside.
Weather Conditions and Skin Irritation
Certain weather conditions, such as cold and wind, can irritate your skin. Consult with your doctor or pharmacist for guidance on how to protect your skin in these conditions.
Precautions and Interactions
Do not wax the affected skin, as this can cause irritation. Using other skin products while taking this medication can increase the risk of irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe use.
Potential Side Effects
It may take several weeks to experience the full effects of this medication. If you swallow this medication, it can cause harm, so it is essential to call a doctor or poison control center immediately if this happens. Some people may experience skin reactions, such as burning, dryness, redness, scaling, or stinging, where the medication is applied. In most cases, these reactions will resolve within 4 weeks after starting the medication. However, if these reactions persist or worsen, consult with your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of using this medication with your doctor to ensure the best possible outcome for you and your baby. If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Scaling
- Dryness
- Stinging
- Burning
What to Do:
Topical overdose is unlikely to cause systemic effects. If excessive application occurs, discontinue use temporarily until irritation subsides. For accidental ingestion, seek medical attention or call a poison control center (1-800-222-1222).
Drug Interactions
Moderate Interactions
- Other topical retinoids (e.g., tretinoin, tazarotene) - increased irritation
- Other topical products with strong drying or irritating effects (e.g., salicylic acid, sulfur, resorcinol, abrasive soaps, cleansers, astringents, alcohol-containing products) - increased irritation
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To establish baseline severity of acne and identify any pre-existing skin irritation or sensitivity.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin reactions (erythema, scaling, dryness, stinging/burning)
Frequency: Regularly during treatment, especially during the first 4 weeks
Target: Mild to moderate; severe reactions warrant dose adjustment or temporary discontinuation.
Action Threshold: If severe irritation persists, reduce frequency or temporarily discontinue. If symptoms of allergic reaction occur, discontinue immediately.
Therapeutic response (reduction in acne lesions)
Frequency: Monthly or as clinically indicated
Target: Progressive improvement in lesion count
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Excessive dryness
- Severe redness
- Significant peeling or flaking
- Intense stinging or burning
- Swelling
- Itching
- Blistering or crusting (rare, severe reaction)
- Signs of allergic reaction (e.g., hives, difficulty breathing, swelling of face/lips/tongue/throat)
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, retinoids are known teratogens when administered systemically. Discontinue if pregnancy is confirmed.
Trimester-Specific Risks:
First Trimester:
Potential risk, though systemic absorption is minimal. Avoid if possible.
Second Trimester:
Potential risk, though systemic absorption is minimal. Avoid if possible.
Third Trimester:
Potential risk, though systemic absorption is minimal. Avoid if possible.
Lactation
Caution advised. It is not known whether adapalene or benzoyl peroxide are excreted in human milk. Due to minimal systemic absorption, risk to infant is likely low, but apply to areas not in contact with the infant's skin or mouth during feeding.
Infant Risk:
Low risk (L3) due to minimal systemic absorption, but direct contact with infant should be avoided.
Pediatric Use
Approved for use in patients 9 years of age and older. Safety and effectiveness in children younger than 9 years have not been established.
Geriatric Use
No specific studies have been conducted in geriatric patients. However, due to minimal systemic absorption, no specific dose adjustments or precautions are generally necessary.
Clinical Information
Clinical Pearls
- Patients should be advised that some irritation (redness, dryness, peeling, stinging/burning) is common, especially during the first few weeks of treatment, and usually subsides with continued use.
- Emphasize the importance of consistent daily use for optimal results, even if initial irritation occurs.
- Advise patients to use a gentle, non-comedogenic moisturizer to help manage dryness and irritation.
- Remind patients that Epiduo Gel can bleach hair and colored fabrics; apply carefully and allow to dry completely.
- Full therapeutic effect may take up to 12 weeks; encourage patience and adherence to the treatment regimen.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, tazarotene, trifarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide monotherapy
- Topical salicylic acid
- Topical azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (for female patients)
Cost & Coverage
Average Cost:
Varies widely per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or 3 for brand, Tier 1 for generic. Coverage 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 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 information about the medication taken, the amount, and the time it happened.