Benzepro 5.3% Emollient Foam 100gm

Manufacturer PRUGEN Active Ingredient Benzoyl Peroxide Foam(BEN zoe il peer OKS ide) Pronunciation BEN-zoy-il peer-OKS-ide
It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anti-acne agent
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Pharmacologic Class
Keratolytic, antibacterial (oxidizing agent), comedolytic
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Benzoyl peroxide is a topical medicine used to treat acne. It works by killing the bacteria that cause acne and by helping to unclog pores, reducing blackheads and whiteheads.
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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 prevent the spread of infection. You can apply makeup after the skin has dried completely. 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 a while, you may need to prime the pump. Be sure to understand when and how to prime the pump. If you have any questions, consult your doctor or pharmacist.

To use the medication, hold the container upright and do not turn it upside down. Clean and dry the affected skin area before applying a thin layer of the medication and gently rubbing it in. You may need to rinse the affected skin after some time, following the instructions provided by your doctor or the package insert.

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 protect it from puncture or burning, even if it seems empty.

Missed 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 the missed one.
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Lifestyle & Tips

  • Apply to clean, dry skin. Wash hands thoroughly after application.
  • Avoid contact with eyes, mouth, nostrils, and mucous membranes. If contact occurs, rinse thoroughly with water.
  • Benzoyl peroxide can bleach hair, colored fabrics, towels, and carpets. Allow product to dry completely before contact with clothing or bedding.
  • Use sunscreen daily and limit sun exposure, as benzoyl peroxide can increase sun sensitivity.
  • Avoid using harsh or abrasive cleansers, scrubs, or alcohol-containing products on treated areas, as this can increase irritation.
  • Consistency is key; it may take several weeks to see noticeable improvement.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer of foam to affected areas once or twice daily.

Condition-Specific Dosing:

initial_therapy: Start with once daily application to assess skin tolerance, then increase to twice daily if tolerated.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (generally not recommended for children under 12 years without medical supervision)
Adolescent: Typically same as adult dosing (12 years and older)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Benzoyl peroxide is a potent oxidizing agent that releases free oxygen radicals. These radicals are bactericidal against Cutibacterium acnes (formerly Propionibacterium acnes), the bacteria primarily responsible for acne lesions. It also possesses keratolytic and comedolytic properties, promoting the shedding of dead skin cells and preventing the formation of new comedones (clogged pores).
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (<5%)
Tmax: Not applicable (primarily local action)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (primarily local action)
ProteinBinding: Not applicable (primarily local action)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (primarily local action)
Clearance: Not applicable (primarily local action)
ExcretionRoute: Benzoic acid is excreted renally
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Gradual, typically 3-4 weeks for noticeable improvement
PeakEffect: 8-12 weeks of consistent use
DurationOfAction: Requires continuous use for sustained effect

Safety & Warnings

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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
- A 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe burning
  • Intense stinging
  • Excessive redness or swelling
  • Blistering or crusting of the skin
  • Signs of allergic reaction (e.g., rash, itching, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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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.
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 your safety, 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

Carefully review your medication list and health history with your doctor to confirm that it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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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 the instructions provided by your doctor or as outlined 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 medications 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, as it may cause bleaching of hair or colored fabrics.

If this medication is swallowed, it can cause harm. In the event of ingestion, immediately contact a doctor or poison control center.

If you are pregnant, planning 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.
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Overdose Information

Overdose Symptoms:

  • Severe skin irritation (redness, burning, stinging, peeling)
  • Not expected to cause systemic toxicity due to minimal absorption

What to Do:

Discontinue use immediately. Apply cool compresses to affected area. If irritation persists or is severe, seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical care.

Drug Interactions

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Moderate Interactions

  • Topical dapsone (can cause temporary yellow/orange skin discoloration)
  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene - increased irritation/dryness if applied simultaneously; consider applying at different times of day)
  • Sulfonamide-containing topical products (potential for increased irritation)
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Minor Interactions

  • Other topical irritants (e.g., salicylic acid, alpha hydroxy acids, alcohol-containing products - increased dryness/irritation)

Monitoring

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Baseline Monitoring

Skin assessment

Rationale: To determine baseline acne severity, skin type, and presence of existing irritation.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in acne lesions)

Frequency: Monthly or as clinically indicated

Target: Improvement in lesion count and overall skin appearance

Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of treatment plan.

Skin irritation (redness, dryness, peeling, stinging, burning)

Frequency: Daily during initial therapy, then as needed

Target: Mild, tolerable irritation is common; severe irritation is not acceptable.

Action Threshold: If severe irritation, burning, or blistering occurs, discontinue use and consult a healthcare professional.

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Symptom Monitoring

  • Excessive dryness
  • Peeling
  • Redness (erythema)
  • Stinging or burning sensation
  • Itching
  • Swelling
  • Blistering (rare, indicates severe irritation/allergic reaction)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected.

Trimester-Specific Risks:

First Trimester: Limited data, but minimal systemic absorption suggests low risk.
Second Trimester: Limited data, but minimal systemic absorption suggests low risk.
Third Trimester: Limited data, but minimal systemic absorption suggests low risk.
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Lactation

L3 (Moderately Safe). Minimal risk to the infant due to very low systemic absorption. Avoid applying to areas where the infant may come into direct contact, especially the breast area.

Infant Risk: Low risk of adverse effects in breastfed infants.
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Pediatric Use

Generally considered safe and effective for adolescents (12 years and older). Use in younger children (under 12) is not well-established and should be under the guidance of a pediatrician due to potential for increased skin sensitivity.

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Geriatric Use

No specific dose adjustments are typically needed. However, geriatric patients may have more fragile or sensitive skin, so caution and careful monitoring for irritation are advised.

Clinical Information

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Clinical Pearls

  • Benzoyl peroxide can be irritating, especially when first starting treatment. Advise patients to start with a lower strength or less frequent application (e.g., once daily or every other day) and gradually increase as tolerated.
  • Warn patients about the bleaching effect on fabrics, towels, and hair. Advise them to apply the product well before bedtime and use white towels/pillowcases.
  • Emphasize the importance of consistent use for optimal results, as improvement is gradual and takes several weeks.
  • Always advise patients to use a non-comedogenic moisturizer and sunscreen daily, as benzoyl peroxide can cause dryness and increase sun sensitivity.
  • If using in combination with topical retinoids, advise patients to apply them at different times of the day (e.g., BPO in the morning, retinoid at night) to minimize irritation and potential degradation of the retinoid.
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Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
  • Topical antibiotics (e.g., clindamycin, erythromycin)
  • Salicylic acid (topical)
  • Azelaic acid (topical)
  • Oral antibiotics (e.g., doxycycline, minocycline)
  • Oral isotretinoin (for severe, recalcitrant acne)
  • Hormonal therapies (e.g., oral contraceptives, spironolactone for hormonal acne)
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Cost & Coverage

Average Cost: Varies widely ($30 - $150+) per 100gm foam
Generic Available: Yes
Insurance Coverage: Often covered by most prescription drug plans, especially generic formulations. May be Tier 1 or Tier 2.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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.