Adapal/benz 0.1-2.5% Gel (pmp) 45g
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid-like compound; Keratolytic; Antimicrobial
Pregnancy Category
Category C
FDA Approved
Aug 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
This gel is a combination medicine used on the skin to treat acne. Adapalene helps to prevent pimples and blackheads by affecting skin cell growth, and benzoyl peroxide kills bacteria that cause acne and helps to unclog pores.
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.
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 make sure 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 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.
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 make sure 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 excessive sun exposure and use sunscreen (SPF 30 or higher) and protective clothing, as this medication can increase sun sensitivity.
- Avoid using harsh or abrasive skin products (e.g., medicated soaps, cleansers, astringents, alcohol-containing products) that can increase irritation.
- Benzoyl peroxide can bleach hair and colored fabrics (towels, pillowcases, clothing); allow the gel to dry completely before contact with these items.
- Moisturize regularly to help manage dryness and irritation.
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, after washing gently with a mild cleanser and drying.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to affected areas once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 9 years of age and older: Apply a thin layer to affected areas once daily in the evening.
Adolescent:
Apply a thin layer to affected areas once daily in the evening.
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 does not bind to the cytosolic receptor protein. It normalizes follicular keratinization, which reduces microcomedone formation. Benzoyl Peroxide is an oxidizing agent with bactericidal and keratolytic effects. It releases free oxygen radicals that are toxic to P. acnes (now Cutibacterium acnes) and also helps to shed dead skin cells and unclog pores.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <0.25% for adapalene, <5% for benzoyl peroxide converted to benzoic acid).
Tmax:
Not applicable for topical systemic effects; localized action.
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not applicable (primarily localized to skin).
ProteinBinding:
Not applicable (minimal systemic absorption).
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption).
Clearance:
Not applicable (minimal systemic absorption).
ExcretionRoute:
Adapalene: Primarily biliary excretion. Benzoyl Peroxide: Benzoic acid excreted renally.
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Noticeable improvement typically within 1-4 weeks; full therapeutic effect may take 8-12 weeks.
PeakEffect:
8-12 weeks of continuous use.
DurationOfAction:
Requires continuous application for sustained effect.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ 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 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ 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 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)
- Blistering or crusting of the skin
- Signs of an allergic reaction (e.g., rash, itching/swelling, 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 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 or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other 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 or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other 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 crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Allergic Reactions and Irritation
Certain acne products, including 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 minimize the risk of 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.
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 in conjunction with this medication may increase the risk of irritation. Before using any other medications 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 accidentally swallow this medication, seek medical attention immediately by calling a doctor or poison control center. 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 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 potential benefits and risks of using this medication to you and your baby. If you are breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Allergic Reactions and Irritation
Certain acne products, including 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 minimize the risk of 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.
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 in conjunction with this medication may increase the risk of irritation. Before using any other medications 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 accidentally swallow this medication, seek medical attention immediately by calling a doctor or poison control center. 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 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 potential benefits and risks of using this medication to you and your baby. If you are breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Scaling
- Dryness
- Burning
- Stinging
What to Do:
Topical overdose is unlikely to cause systemic effects. Discontinue use temporarily or reduce frequency until irritation subsides. If severe irritation occurs, seek medical advice. For accidental ingestion, call a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Other topical retinoids (e.g., tretinoin, tazarotene) - increased irritation.
- Products containing alpha hydroxy acids (AHAs), salicylic acid, sulfur, or resorcinol - increased irritation.
- Products with strong drying or irritating effects (e.g., abrasive soaps, cleansers, astringents, alcohol-containing products) - increased irritation.
- Photosensitizing agents (e.g., tetracyclines, fluoroquinolones, phenothiazines) - increased risk of photosensitivity.
Monitoring
Baseline Monitoring
Skin assessment (type, severity of acne, presence of irritation)
Rationale: To establish baseline for treatment efficacy and adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning/stinging)
Frequency: Daily during initial 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; signs of allergic reaction.
Acne lesion count and severity
Frequency: Monthly or every 2-3 months.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: No improvement after 8-12 weeks, or worsening of condition.
Symptom Monitoring
- Skin redness
- Dryness
- Peeling/scaling
- Burning sensation
- Stinging sensation
- Itching
- Swelling
- Blistering (rare, severe reaction)
- Discoloration of hair or fabrics (due to benzoyl peroxide)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, topical retinoids should be used with caution.
Trimester-Specific Risks:
First Trimester:
Potential risk, but systemic absorption is very low. Consider alternative if possible.
Second Trimester:
Potential risk, but systemic absorption is very low.
Third Trimester:
Potential risk, but systemic absorption is very low.
Lactation
L3 (Moderately safe). It is not known whether adapalene or benzoyl peroxide are excreted in human milk. Due to minimal systemic absorption, risk to the infant is considered low. However, caution should be exercised. Avoid applying to areas where the infant may come into direct contact, especially the breast area.
Infant Risk:
Low risk due to minimal systemic absorption, but potential for exposure if applied to areas accessible to the infant.
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
Acne vulgaris is less common in the geriatric population. No specific dose adjustments are necessary based on age, as systemic absorption is minimal. However, older patients may have more fragile or sensitive skin and may experience increased irritation.
Clinical Information
Clinical Pearls
- A 'purging' effect (initial worsening of acne) can occur during the first few weeks of treatment as the medication works to bring underlying lesions to the surface. This is usually temporary.
- Consistency is key; apply daily as directed, even if acne appears to be improving.
- Start with a pea-sized amount for the entire face. More is not better and can lead to increased irritation.
- Apply to the entire affected area, not just individual pimples, to prevent new lesions.
- Avoid waxing on treated areas, as skin may be more fragile and prone to tearing.
- Benzoyl peroxide can bleach fabrics and hair; apply before bed and use white towels/pillowcases.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical salicylic acid
- Topical azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
- Chemical peels, laser therapy, light therapy
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 45g tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.