Benzepro 5.3% Emollient Foam 60gm
It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anti-acne agent
Pharmacologic Class
Keratolytic, antibacterial, oxidizing agent
Pregnancy Category
Category C
FDA Approved
Jun 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Benzepro foam is a medicine used on the skin to treat acne. It works by killing the bacteria that cause acne and by helping to remove dead skin cells that can clog pores.
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. This medication is for topical use only, meaning it should be applied directly to the affected skin area. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Before and after applying the medication, wash your hands to maintain cleanliness. You can apply makeup after the treated skin has dried. If you notice the medication or white marks on your skin after application, you may be using too much. It's essential to continue using the medication as directed, even if your symptoms improve, as it may take several weeks to experience the full effects.
Preparing the Medication for Use
Before using the medication for the first time, or if it has not been used for some time, you will need to prime the pump. It's crucial to understand when and how to prime the pump, so consult your doctor or pharmacist if you have any questions. Always hold the container upright when using the medication, and avoid turning it upside down.
Applying the Medication
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. You may need to rinse the treated area after some time, so be sure to follow your doctor's instructions or the package insert for specific guidance.
Storage and Disposal
Store the medication at room temperature in a dry place, away from heat and sunlight. Do not store it in a bathroom. Keep the container upright with the cap on, and avoid puncturing or burning it, even if it seems empty.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected skin area. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Before and after applying the medication, wash your hands to maintain cleanliness. You can apply makeup after the treated skin has dried. If you notice the medication or white marks on your skin after application, you may be using too much. It's essential to continue using the medication as directed, even if your symptoms improve, as it may take several weeks to experience the full effects.
Preparing the Medication for Use
Before using the medication for the first time, or if it has not been used for some time, you will need to prime the pump. It's crucial to understand when and how to prime the pump, so consult your doctor or pharmacist if you have any questions. Always hold the container upright when using the medication, and avoid turning it upside down.
Applying the Medication
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. You may need to rinse the treated area after some time, so be sure to follow your doctor's instructions or the package insert for specific guidance.
Storage and Disposal
Store the medication at room temperature in a dry place, away from heat and sunlight. Do not store it in a bathroom. Keep the container upright with the cap on, and avoid puncturing or burning it, even if it seems empty.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Cleanse skin gently before applying the foam.
- Apply a thin layer to affected areas, avoiding eyes, mouth, and mucous membranes.
- Wash hands thoroughly after application.
- Avoid excessive sun exposure and use sunscreen, as benzoyl peroxide can increase sun sensitivity.
- Avoid contact with hair and colored fabrics, as benzoyl peroxide can bleach them.
- Do not use on broken, irritated, or sunburned skin.
- Be patient; it may take several weeks to see improvement.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas once daily or as directed by physician.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to affected areas once daily. May increase frequency if tolerated and directed by physician.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age. For children 12 years and older, apply to affected areas once daily or as directed by physician.
Adolescent:
Apply to affected areas once daily or as directed by physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Benzoyl peroxide is an oxidizing agent that exhibits bactericidal activity against Propionibacterium acnes (now Cutibacterium acnes), the bacterium largely responsible for acne vulgaris. It also has keratolytic and comedolytic properties, promoting the shedding of dead skin cells and preventing the formation of new comedones.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<5%)
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (local action)
ProteinBinding:
Not applicable (local action)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (local action, rapid conversion)
Clearance:
Not applicable (local action)
ExcretionRoute:
Benzoic acid is excreted in the urine
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Weeks (typically 3-4 weeks for noticeable improvement)
PeakEffect:
8-12 weeks
DurationOfAction:
Continuous with regular use
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, or swelling of the mouth, face, lips, tongue, or throat.
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Burning, itching, dryness, or irritation at the application site
- Stinging
- Scaling
- Peeling
- Feeling of warmth
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, or swelling of the mouth, face, lips, tongue, or throat.
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Burning, itching, dryness, or irritation at the application site
- Stinging
- Scaling
- Peeling
- Feeling of warmth
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. 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
- Excessive dryness or peeling
- Burning or stinging that does not subside
- Swelling
- Blistering
- Itching or rash (signs of allergic reaction)
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.
If you have highly sensitive skin, as this may affect your ability to tolerate the medication.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions or adverse effects.
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.
If you have highly sensitive skin, as this may affect your ability to tolerate the medication.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions or adverse effects.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When using certain acne products that contain benzoyl peroxide or salicylic acid, there is a rare risk of severe and potentially life-threatening allergic reactions or significant irritation. To minimize this risk, you may need to follow specific steps before your first use, as advised by your doctor.
To use this medication correctly, follow your doctor's instructions or the guidelines on the package label. If you have any questions or concerns, discuss them with your doctor.
Avoid applying this medication to cuts, scrapes, eczema, or damaged skin, as well as sunburned skin. Do not leave the medication on your skin for longer than recommended by your doctor.
Using other skin products in conjunction with this medication may increase the risk of irritation. To help manage skin reactions, moisturize your skin as directed by your doctor.
Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe use.
You may be more susceptible to sunburn while using this medication. To protect yourself, avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.
When applying this medication, exercise caution to avoid accidental contact with hair or colored fabrics, as it may cause bleaching.
If this medication is swallowed, it can be harmful. In the event of ingestion, immediately contact a doctor or poison control center.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
When using certain acne products that contain benzoyl peroxide or salicylic acid, there is a rare risk of severe and potentially life-threatening allergic reactions or significant irritation. To minimize this risk, you may need to follow specific steps before your first use, as advised by your doctor.
To use this medication correctly, follow your doctor's instructions or the guidelines on the package label. If you have any questions or concerns, discuss them with your doctor.
Avoid applying this medication to cuts, scrapes, eczema, or damaged skin, as well as sunburned skin. Do not leave the medication on your skin for longer than recommended by your doctor.
Using other skin products in conjunction with this medication may increase the risk of irritation. To help manage skin reactions, moisturize your skin as directed by your doctor.
Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe use.
You may be more susceptible to sunburn while using this medication. To protect yourself, avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.
When applying this medication, exercise caution to avoid accidental contact with hair or colored fabrics, as it may cause bleaching.
If this medication is swallowed, it can be harmful. In the event of ingestion, immediately contact a doctor or poison control center.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe skin irritation
- Redness
- Burning
- Stinging
- Peeling
What to Do:
Discontinue use and wash the area thoroughly with water. Apply a soothing moisturizer. If irritation persists or is severe, seek medical attention. For accidental ingestion, contact a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Dapsone topical (may cause temporary yellow/orange skin discoloration)
- Tretinoin topical (may degrade tretinoin; apply at different times of day)
- Adapalene topical (may increase irritation; apply at different times of day)
- Tazarotene topical (may increase irritation; apply at different times of day)
- Sulfonamide-containing products (may cause temporary skin discoloration)
Monitoring
Baseline Monitoring
Skin assessment (redness, dryness, peeling, irritation)
Rationale: To establish baseline skin condition and identify potential sensitivities before starting treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin assessment (redness, dryness, peeling, irritation)
Frequency: Daily or as needed
Target: Mild to no irritation
Action Threshold: Discontinue use or reduce frequency if severe irritation, burning, or blistering occurs.
Acne lesion count/severity
Frequency: Monthly or as needed
Target: Reduction in inflammatory and non-inflammatory lesions
Action Threshold: Re-evaluate treatment if no improvement after 8-12 weeks.
Symptom Monitoring
- Excessive dryness
- Redness
- Peeling
- Stinging
- Burning
- Itching
- Swelling
- Blistering (severe reaction)
- Allergic contact dermatitis (rare)
Special Patient Groups
Pregnancy
Benzoyl peroxide is classified as Pregnancy Category C. While systemic absorption is minimal, use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Limited data; minimal systemic absorption suggests low risk, but caution advised.
Second Trimester:
Limited data; minimal systemic absorption suggests low risk, but caution advised.
Third Trimester:
Limited data; minimal systemic absorption suggests low risk, but caution advised.
Lactation
It is not known whether benzoyl peroxide is excreted in human milk. Due to minimal systemic absorption, it is generally considered low risk for topical use during breastfeeding. However, caution is advised, and direct contact with the infant's skin should be avoided, especially on areas that may come into contact with the infant's mouth.
Infant Risk:
Low risk (L3 - Moderately Safe) due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in adolescents (12 years and older) is generally considered safe and effective.
Geriatric Use
No specific dosage adjustments or precautions are necessary for geriatric patients. The safety and efficacy profile is expected to be similar to that in younger adults.
Clinical Information
Clinical Pearls
- Benzoyl peroxide can cause significant skin dryness, redness, and peeling, especially during the initial weeks of treatment. Advise patients to start with a lower frequency (e.g., every other day) and gradually increase as tolerated.
- Emollient foam formulations like Benzepro are often better tolerated by patients with sensitive or dry skin compared to gels or creams, due to their moisturizing properties.
- Always remind patients about the bleaching effect on clothing, towels, and hair.
- Sun protection is crucial due to increased photosensitivity.
- Combining with a non-comedogenic moisturizer can help manage dryness and irritation.
- For best results, ensure consistent daily application, even after acne starts to clear.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Salicylic acid
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral retinoids (e.g., isotretinoin for severe acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 60gm foam
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand-name prescription foam); Tier 1 for generic OTC products
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 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 details about the medication taken, the amount, and the time it occurred.