Epiduo Forte 0.3-2.5% Gel 60gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid; Keratolytic; Antimicrobial
Pregnancy Category
Category C
FDA Approved
Jul 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Epiduo Forte Gel is a topical medication used to treat acne. It contains two active ingredients: Adapalene, which helps to prevent pimples from forming and reduces inflammation, and Benzoyl Peroxide, which kills acne-causing bacteria and helps to unclog pores. It's applied to the skin once a day.
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 applying the medication to sensitive areas, including your mouth, nose, and eyes, as it may cause burning.
Do not apply the medication to the vagina or to areas with cuts, scrapes, eczema, or damaged skin.
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, protected 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.
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 applying the medication to sensitive areas, including your mouth, nose, and eyes, as it may cause burning.
Do not apply the medication to the vagina or to areas with cuts, scrapes, eczema, or damaged skin.
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, protected 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.
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 a thin layer to clean, dry skin once daily in the evening.
- Avoid contact with eyes, lips, nostrils, and mucous membranes.
- Avoid applying to cuts, abrasions, or sunburned/irritated skin.
- Use sunscreen daily and wear protective clothing when outdoors, as this medication can increase sensitivity to the sun.
- Use a gentle, non-comedogenic cleanser and moisturizer.
- Avoid waxing on treated areas, as skin may be more fragile.
- Be aware that the gel may bleach hair or colored fabrics.
Available Forms & Alternatives
Available Strengths:
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:
application_method:
Wash and gently dry the skin before application. Apply a thin layer, avoiding the eyes, lips, and mucous membranes. Do not apply to cuts, abrasions, eczematous or sunburned skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 9 years of age.
Adolescent:
For patients 9 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 due to minimal systemic absorption.
Moderate:
No dosage adjustment necessary due to minimal systemic absorption.
Severe:
No dosage adjustment necessary due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No dosage adjustment necessary due to minimal systemic absorption.
Moderate:
No dosage adjustment necessary due to minimal systemic absorption.
Severe:
No dosage adjustment necessary due to 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 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 oxygen radicals that oxidize bacterial proteins, effectively killing *Cutibacterium acnes* (formerly *Propionibacterium acnes*). It also helps to shed dead skin cells and unclog pores.
Pharmacokinetics
Absorption:
Bioavailability:
Very low systemic absorption for both components.
Tmax:
Adapalene: Typically 3-6 hours, but plasma concentrations are often below the limit of quantification (0.1 ng/mL). Benzoyl Peroxide: Rapidly converted to benzoic acid upon skin absorption.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Adapalene: Approximately 99.9% bound to plasma proteins (in vitro). Benzoyl Peroxide: Not applicable (rapidly metabolized).
CnssPenetration:
Limited
Elimination:
HalfLife:
Adapalene: Not precisely quantifiable due to low systemic levels, but elimination from tissues is slow. Benzoyl Peroxide: Benzoic acid is rapidly eliminated.
Clearance:
Not precisely quantifiable due to low systemic levels.
ExcretionRoute:
Adapalene: Primarily biliary excretion. Benzoyl Peroxide: Benzoic acid is excreted in the urine.
Unchanged:
Not available (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Initial improvement may be seen within 1 week, but significant therapeutic effects typically take 8-12 weeks.
PeakEffect:
Typically 8-12 weeks of consistent use.
DurationOfAction:
Maintained with continued use; effects diminish upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 medical attention 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
Severe skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
If you have questions or concerns about side effects, don't hesitate to reach out to your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 medical attention 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
Severe skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
If you have questions or concerns about side effects, don't hesitate to reach out to your doctor for medical advice. 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 redness, dryness, scaling, burning, or stinging that does not improve or worsens significantly.
- Swelling or blistering of the skin (signs of a severe allergic reaction or severe irritation).
- Difficulty breathing or swelling of the face/throat (signs of a severe allergic reaction - seek immediate medical attention).
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions, as this drug may affect or be affected by other drugs or health problems.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
All your health problems, as they may impact the safety and effectiveness of this medication.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so. This precaution is crucial to avoid potential interactions or adverse effects.
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions, as this drug may affect or be affected by other drugs or health problems.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
All your health problems, as they may impact the safety and effectiveness of this medication.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so. This precaution is crucial to avoid potential interactions or adverse effects.
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 sunlight, 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 for guidance on how to protect your skin in these conditions.
Additional Precautions
Avoid waxing the affected skin, as this can cause further 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 be harmful, so it is essential to call a doctor or poison control center immediately if this occurs. Common skin reactions, such as burning, dryness, redness, scaling, or stinging, may occur at the application site. 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 potential benefits and risks of using this medication with your doctor. If you are breastfeeding, avoid applying this medication directly to the nipple or 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 sunlight, 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 for guidance on how to protect your skin in these conditions.
Additional Precautions
Avoid waxing the affected skin, as this can cause further 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 be harmful, so it is essential to call a doctor or poison control center immediately if this occurs. Common skin reactions, such as burning, dryness, redness, scaling, or stinging, may occur at the application site. 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 potential benefits and risks of using this medication with your doctor. If you are breastfeeding, avoid applying this medication directly to the nipple or 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, discontinue use temporarily until irritation subsides. If accidentally ingested, seek medical attention or call a poison control center (1-800-222-1222).
Drug Interactions
Moderate Interactions
- Other topical preparations with a strong irritant or drying effect (e.g., abrasive soaps, cleansers, alcohol-containing products, astringents, other retinoids, salicylic acid, sulfur, resorcinol) due to potential for additive irritation.
- Products containing alpha hydroxy acids (AHAs) or beta hydroxy acids (BHAs) due to potential for increased irritation.
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To evaluate the severity of acne and identify any pre-existing skin irritation or conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, stinging/burning)
Frequency: Regularly, especially during the first 4 weeks of treatment.
Target: Mild to moderate irritation is expected; severe irritation should prompt re-evaluation.
Action Threshold: If severe irritation occurs, reduce frequency of application or temporarily discontinue use until irritation subsides. Consult healthcare provider if persistent or severe.
Therapeutic response (reduction in acne lesions)
Frequency: Every 4-8 weeks, or as clinically indicated.
Target: Gradual improvement in inflammatory and non-inflammatory lesions.
Action Threshold: If no significant improvement after 12 weeks, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Stinging
- Burning
- Itching
- Swelling
- Blistering (rare, severe irritation)
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.
Trimester-Specific Risks:
First Trimester:
Potential risk, as organogenesis occurs during this period. Avoid use if possible.
Second Trimester:
Potential risk, though less critical than first trimester. Use with caution.
Third Trimester:
Potential risk. Use with caution.
Lactation
Caution should be exercised when Epiduo Forte is administered to a nursing woman. It is not known whether adapalene or benzoyl peroxide are excreted in human milk. Due to minimal systemic absorption, risk to infant is considered low, but avoid applying to areas where the infant may come into direct contact with the medication.
Infant Risk:
Low risk, but caution advised.
Pediatric Use
Approved for use in patients 9 years of age and older. Safety and effectiveness in pediatric patients younger than 9 years have not been established.
Geriatric Use
No specific dosage adjustments or precautions are recommended 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.
Clinical Information
Clinical Pearls
- Patients should be advised that a transient feeling of warmth or slight stinging may occur immediately after application.
- Initial worsening of acne (purging) can occur during the first few weeks of treatment due to the medication's effect on existing microcomedones; this is usually temporary.
- Consistency is key for optimal results; patients should be encouraged to use the medication daily as prescribed.
- Emphasize the importance of daily sunscreen use due to increased photosensitivity.
- Advise patients to use a gentle, non-irritating cleanser and moisturizer to help manage dryness and irritation.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, tazarotene, trifarotene)
- Topical benzoyl peroxide (monotherapy)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical dapsone
- 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 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand name), Tier 1 (Generic if available)
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.