Adapal/benz 0.3-2.5% Gel(pmp) 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid-like agent; Keratolytic; Antimicrobial
Pregnancy Category
Category C
FDA Approved
Oct 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
This is a topical gel containing two medicines, adapalene and benzoyl peroxide, used to treat acne. Adapalene helps to unclog pores and reduce inflammation, while benzoyl peroxide kills acne-causing bacteria and helps shed dead skin cells.
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.
Do not use this medication on cuts, scrapes, eczema, or damaged skin.
Avoid applying the medication to sunburned skin.
Wash your hands before and after using the medication.
Clean the affected area before applying the medication and make sure it is 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.
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 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.
Do not use this medication on cuts, scrapes, eczema, or damaged skin.
Avoid applying the medication to sunburned skin.
Wash your hands before and after using the medication.
Clean the affected area before applying the medication and make sure it is 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.
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.
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 application to cuts, abrasions, or eczematous skin.
- Limit sun exposure, including tanning beds, and use sunscreen and protective clothing when outdoors, as this medication can increase sensitivity to sunlight.
- Avoid waxing on treated skin.
- May bleach hair or colored fabrics; wash hands thoroughly after application.
- 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:
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 adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed 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-radical oxygen, which oxidizes bacterial proteins, thereby killing Propionibacterium acnes (now Cutibacterium acnes). It also has a mild keratolytic effect, which helps to prevent clogged pores.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption for both components. Adapalene plasma concentrations are generally below the limit of quantification (0.1 ng/mL). Benzoyl peroxide is absorbed into the skin where it is converted to benzoic acid.
Tmax:
Not applicable for topical application with minimal systemic absorption.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not applicable due to minimal systemic absorption.
ProteinBinding:
Not applicable due to minimal systemic absorption.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely quantifiable due to minimal systemic absorption.
Clearance:
Not precisely quantifiable due to minimal systemic absorption.
ExcretionRoute:
Adapalene: Primarily biliary excretion. Benzoyl Peroxide: Benzoic acid is primarily excreted in the urine.
Unchanged:
Not applicable due to minimal systemic absorption and rapid metabolism of benzoyl peroxide.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1 to 4 weeks.
PeakEffect:
Optimal results may take 8 to 12 weeks of continuous use.
DurationOfAction:
Effects persist with continued daily application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
If you experience any of the following symptoms, call your doctor or seek medical help right away, as they may be signs of a severe and potentially life-threatening side effect:
- 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have 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, your doctor is available to provide guidance.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also a valuable resource for medical advice regarding side effects.
If you experience any of the following symptoms, call your doctor or seek medical help right away, as they may be signs of a severe and potentially life-threatening side effect:
- 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you have 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, your doctor is available to provide guidance.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also a valuable resource for medical advice regarding side effects.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (e.g., excessive redness, dryness, scaling, burning, stinging) that does not improve or worsens.
- Signs of an allergic reaction (e.g., rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing).
- 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.
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.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify 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.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Precautions
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 containing benzoyl peroxide or salicylic acid can cause severe and potentially life-threatening allergic reactions or irritation. Before using this medication for the first time, you may need to follow specific steps to ensure you do not have an allergic reaction. Use this medication exactly as directed by your doctor or as instructed on the package label. If you have any questions, consult with your doctor.
Application and Skin Care
When applying this medication, exercise caution to avoid bleaching hair or colored fabrics. Be aware that your skin may appear worse before it starts to improve. You may also be more susceptible to sunburn, so it is crucial to avoid exposure to the sun, sunlamps, and tanning beds. Use a sunscreen and wear protective clothing and eyewear to shield your skin from the sun.
Environmental Factors 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. Avoid waxing the affected skin, as this can cause further irritation. Using other skin products while taking this medication may increase the risk of irritation, so be sure to discuss this with your doctor before using any other products, including soaps.
Potential Side Effects and Risks
It may take several weeks to experience the full effects of this medication. If you accidentally swallow this medication, call your doctor or a poison control center immediately, as it can cause harm. Common skin reactions, such as burning, dryness, redness, scaling, or stinging, may occur at the application site. These reactions usually resolve within 4 weeks of 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 to ensure the best possible outcome for you and your baby. 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 containing benzoyl peroxide or salicylic acid can cause severe and potentially life-threatening allergic reactions or irritation. Before using this medication for the first time, you may need to follow specific steps to ensure you do not have an allergic reaction. Use this medication exactly as directed by your doctor or as instructed on the package label. If you have any questions, consult with your doctor.
Application and Skin Care
When applying this medication, exercise caution to avoid bleaching hair or colored fabrics. Be aware that your skin may appear worse before it starts to improve. You may also be more susceptible to sunburn, so it is crucial to avoid exposure to the sun, sunlamps, and tanning beds. Use a sunscreen and wear protective clothing and eyewear to shield your skin from the sun.
Environmental Factors 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. Avoid waxing the affected skin, as this can cause further irritation. Using other skin products while taking this medication may increase the risk of irritation, so be sure to discuss this with your doctor before using any other products, including soaps.
Potential Side Effects and Risks
It may take several weeks to experience the full effects of this medication. If you accidentally swallow this medication, call your doctor or a poison control center immediately, as it can cause harm. Common skin reactions, such as burning, dryness, redness, scaling, or stinging, may occur at the application site. These reactions usually resolve within 4 weeks of 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 to ensure the best possible outcome for 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. If excessive application occurs, discontinue use temporarily until irritation subsides. If accidentally ingested, seek medical attention. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Moderate Interactions
- Other topical retinoids or vitamin A derivatives (increased irritation)
- Products containing alpha hydroxy acids (AHAs) or beta hydroxy acids (BHAs) (e.g., glycolic acid, salicylic acid) (increased irritation)
- Topical products containing sulfur, resorcinol, or strong drying agents (increased irritation)
- Abrasive soaps and cleansers, medicated soaps and cleansers, strong drying agents, products with high concentrations of alcohol, astringents, or lime (increased irritation)
Minor Interactions
- Photosensitizing agents (e.g., tetracyclines, fluoroquinolones, thiazide diuretics) (increased risk of photosensitivity)
Monitoring
Baseline Monitoring
Skin assessment (erythema, scaling, dryness, burning/stinging)
Rationale: To establish baseline skin condition and identify potential sensitivities.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning/stinging)
Frequency: Daily, especially during the first few 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 worsening.
Acne lesion count and overall appearance
Frequency: Monthly or as clinically indicated.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Skin redness
- Scaling
- Dryness
- Burning sensation
- Stinging sensation
- Itching
- Swelling
- Allergic reactions (e.g., severe rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
Special Patient Groups
Pregnancy
Adapalene is a retinoid and generally not recommended during pregnancy due to potential teratogenic effects, although systemic absorption is minimal. Benzoyl peroxide is also Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is minimal. Avoid if possible.
Second Trimester:
Risk likely similar to first trimester, but still minimal systemic absorption.
Third Trimester:
Risk likely similar to first trimester, but still minimal systemic absorption.
Lactation
It is not known whether adapalene or benzoyl peroxide are excreted in human milk. Due to minimal systemic absorption, exposure to the infant is expected to be low. However, caution should be exercised. Avoid applying to areas where the infant may come into direct contact with the medication, especially the chest area.
Infant Risk:
L3 (Moderate risk - possible hazard to infant, but benefits may outweigh risks).
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older. Not recommended for use in children under 12 years of age.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dose adjustments are recommended due to minimal systemic absorption.
Clinical Information
Clinical Pearls
- This combination gel is highly effective for inflammatory and non-inflammatory acne.
- Patients should be counseled on expected skin irritation (redness, dryness, peeling) during the initial weeks of treatment, which often subsides with continued use.
- Emphasize the importance of consistent daily application for optimal results, even if irritation occurs (unless severe).
- Strict sun protection is crucial due to increased photosensitivity.
- Advise patients to apply a pea-sized amount for the entire face, avoiding excessive application which can worsen irritation without improving efficacy.
- Avoid concomitant use of other topical products that may cause excessive dryness or irritation.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, tazarotene)
- Topical benzoyl peroxide monotherapy
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical dapsone
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Oral contraceptives (for hormonal acne)
- Spironolactone (for hormonal acne)
Cost & Coverage
Average Cost:
$400 - $600+ per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand). May require prior authorization.
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.