Epiduo Forte 0.3-2.5% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid-like compound (Adapalene); Oxidizing agent/Antimicrobial (Benzoyl Peroxide)
Pregnancy Category
Not available
FDA Approved
Jul 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Epiduo Forte is a gel applied to the skin to treat acne. It contains two active ingredients: adapalene, which helps to unclog pores and reduce inflammation, and benzoyl peroxide, which kills acne-causing bacteria and helps shed dead skin cells. Together, they work to clear up existing acne and prevent new breakouts.
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. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina or to areas with cuts, scrapes, eczema, or damaged skin.
Do not use this medication on sunburned skin.
Before applying the medication, wash your hands thoroughly.
Clean the affected area before use and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature, away from heat and light.
Keep the lid tightly closed to maintain the medication's effectiveness.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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 make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina or to areas with cuts, scrapes, eczema, or damaged skin.
Do not use this medication on sunburned skin.
Before applying the medication, wash your hands thoroughly.
Clean the affected area before use and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature, away from heat and light.
Keep the lid tightly closed to maintain the medication's effectiveness.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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 make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily in the evening.
- Avoid contact with eyes, lips, nostrils, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Wash hands thoroughly after applying the gel.
- Sun sensitivity is increased; use sunscreen daily (SPF 30 or higher), wear protective clothing, and limit sun exposure, including tanning beds.
- Avoid waxing on treated areas as skin may be more fragile.
- Use a mild, non-comedogenic cleanser and moisturizer.
- Avoid other harsh or irritating topical products unless directed by your doctor.
- Benzoyl peroxide can bleach hair and colored fabrics; allow the gel to dry completely before contact with clothing or bedding.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas of the face and/or trunk once daily in the evening.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to affected areas of the face and/or trunk once daily in the evening after washing gently with a mild cleanser and patting dry. Avoid contact with eyes, lips, nostrils, and mucous membranes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For patients 12 years of age and older: Apply a thin layer to affected areas of the face and/or trunk once daily in the evening.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Dialysis:
No specific recommendations; systemic absorption is minimal.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
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 the differentiation of follicular epithelial cells, resulting in decreased microcomedone formation. Benzoyl Peroxide is an oxidizing agent with bactericidal and keratolytic effects. It releases free-radical oxygen, which oxidizes bacterial proteins, thereby reducing P. acnes (now C. acnes) and also has a mild desquamating effect, helping to prevent clogged pores.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption for both components.
Tmax:
Adapalene: <0.25 ng/mL (systemic, very low); Benzoyl Peroxide: Rapidly converted to benzoic acid upon skin penetration.
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not applicable (minimal systemic absorption).
ProteinBinding:
Adapalene: Approximately 99.7% bound to plasma proteins (in vitro); Benzoyl Peroxide: Not applicable (rapidly metabolized).
CnssPenetration:
Limited/No (minimal systemic absorption).
Elimination:
HalfLife:
Adapalene: Not precisely determined due to low systemic levels, but estimated to be several days; Benzoyl Peroxide: Benzoic acid has a half-life of approximately 1 hour.
Clearance:
Not precisely determined for adapalene due to low systemic levels; Benzoic acid is rapidly cleared.
ExcretionRoute:
Adapalene: Primarily biliary excretion; Benzoyl Peroxide: Benzoic acid is primarily excreted in the urine.
Unchanged:
Adapalene: Very little; Benzoyl Peroxide: None (converted to benzoic acid).
Pharmacodynamics
OnsetOfAction:
Improvements typically seen within 1-4 weeks, with full therapeutic effect often taking 8-12 weeks.
PeakEffect:
Optimal results usually observed after 12 weeks of continuous use.
DurationOfAction:
Maintained with continued daily application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
+ Difficulty 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 persist, 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
+ Difficulty 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 persist, 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 redness, dryness, scaling, burning, or stinging that does not improve or worsens.
- Significant swelling or blistering of the skin.
- Signs of an allergic reaction: rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble 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 allergic reaction you experienced, including any symptoms that occurred.
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 this medication may interact with certain conditions.
To ensure your safety, it is vital 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 allergic reaction you experienced, including any symptoms that occurred.
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 this medication may interact with certain conditions.
To ensure your safety, it is vital 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
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, such as those containing 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 yourself, avoid exposure to the sun, sunlamps, and tanning beds, and use sunscreen and wear protective clothing and eyewear when going outside.
Environmental Precautions
Certain weather conditions, such as cold and wind, can irritate your skin. Consult with your doctor or pharmacist about how to protect your skin in these conditions.
Interactions with Other Skin Products
Avoid waxing the affected skin, as this can cause irritation. Using other skin products while taking this medication can also increase the risk of irritation. Before using any other products on your skin, including soaps, consult with your doctor.
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 they 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. 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, such as those containing 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 yourself, avoid exposure to the sun, sunlamps, and tanning beds, and use sunscreen and wear protective clothing and eyewear when going outside.
Environmental Precautions
Certain weather conditions, such as cold and wind, can irritate your skin. Consult with your doctor or pharmacist about how to protect your skin in these conditions.
Interactions with Other Skin Products
Avoid waxing the affected skin, as this can cause irritation. Using other skin products while taking this medication can also increase the risk of irritation. Before using any other products on your skin, including soaps, consult with your doctor.
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 they 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. If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic effects. If excessive application occurs, wash the area gently with warm water. Management is symptomatic and supportive for local irritation. Call a poison control center (1-800-222-1222) for advice if concerned.
Drug Interactions
Moderate Interactions
- Concomitant use of other potentially irritating topical products (e.g., medicated or abrasive soaps and cleansers, soaps and cosmetics with strong drying effects, products with high alcohol content, astringents, toners, sulfur, resorcinol, salicylic acid) should be approached with caution due to potential for additive irritation.
- Products containing alpha hydroxy acids (AHAs) or beta hydroxy acids (BHAs) due to potential for increased irritation.
Minor Interactions
- Excessive sun exposure or artificial UV light (tanning beds) due to increased photosensitivity.
Monitoring
Baseline Monitoring
Skin assessment (type, severity of acne, presence of irritation)
Rationale: To establish baseline for treatment efficacy and tolerability.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning/stinging)
Frequency: Daily for first few weeks, then as needed.
Target: Mild to moderate irritation is common and expected; severe irritation warrants dose reduction or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency of application (e.g., every other day) or temporarily discontinue until irritation subsides. Consult healthcare provider if severe.
Acne lesion count (comedones, inflammatory lesions)
Frequency: Every 4-8 weeks, or as clinically indicated.
Target: Reduction in lesion count.
Action Threshold: Lack of improvement after 12 weeks may indicate need to reassess treatment plan.
Symptom Monitoring
- Skin dryness
- Peeling/scaling
- Redness (erythema)
- Burning sensation
- Stinging sensation
- Itching
- Swelling
- Allergic contact dermatitis (rare, but possible, especially to benzoyl peroxide)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Adapalene is a retinoid, and systemic retinoids are known teratogens. While systemic absorption of topical adapalene is minimal, caution is advised. Benzoyl peroxide is generally considered safer, but the combination product should be used with caution.
Trimester-Specific Risks:
First Trimester:
Potential risk due to adapalene's retinoid properties; avoid if possible.
Second Trimester:
Considered less risky than first trimester, but still use with caution.
Third Trimester:
Considered less risky than first trimester, but still use with caution.
Lactation
Caution should be exercised when Epiduo Forte is administered to a nursing woman. While systemic absorption is minimal, it is unknown whether adapalene or benzoyl peroxide are excreted in human milk. If used, avoid applying to areas where the infant may come into direct contact with the medication (e.g., chest).
Infant Risk:
Low risk due to minimal systemic absorption, but potential for direct exposure to infant.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Approved for use in patients 12 years of age and older.
Geriatric Use
Clinical studies of Epiduo Forte did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dosage adjustments are recommended based on age, as systemic exposure is minimal.
Clinical Information
Clinical Pearls
- Patients should be advised that a transient worsening of acne (purging) may occur during the first few weeks of treatment, which is normal and usually resolves with continued use.
- Emphasize the importance of consistent, once-daily application for optimal results.
- Educate patients on proper application technique: a pea-sized amount for the entire face, applied thinly.
- Stress the importance of sun protection due to increased photosensitivity.
- Advise patients that benzoyl peroxide can bleach fabrics and hair, so they should allow the gel to dry completely and use white towels/pillowcases.
- If irritation is severe, advise patients to reduce application frequency (e.g., every other day) or temporarily stop for a few days, then resume as tolerated, rather than discontinuing entirely.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide (monotherapy)
- Topical salicylic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
Cost & Coverage
Average Cost:
$400 - $600 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization)
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, including the amount taken and the time it happened, to ensure you receive the best possible care.