Plexion Cleanser 9.8-4.8% Liq 285gm

Manufacturer ECKSON LABS Active Ingredient Sulfur and Sulfacetamide Cleanser, Emulsion, and Wash(SUL fur & sul fa SEE ta mide) Pronunciation SUL-fur & sul-fa-SEE-ta-mide
It is used to treat pimples (acne).It is used to treat rosacea.It is used to control seborrheic dermatitis.
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Drug Class
Anti-acne agent; Antiseborrheic agent
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Pharmacologic Class
Sulfonamide antibiotic; Keratolytic
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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?

This is a medicated cleanser containing two active ingredients, sulfur and sulfacetamide, used to treat skin conditions like acne, rosacea, and seborrheic dermatitis. It works by helping to reduce bacteria on the skin, decrease oiliness, and promote the shedding of dead skin cells.
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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. It is essential to use this medication only as directed.

This medication is for topical use only, meaning it should be applied directly to the affected skin area. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
If the medication accidentally comes into contact with your lips or eyelids, rinse the area with water immediately.
Before and after applying the medication, wash your hands thoroughly.
To apply, wet the affected skin area, work the medication into a lather, and then rinse it off completely.
Continue using the medication as instructed, even if your symptoms improve.
Unless directed by your doctor, do not cover the treated area with bandages, dressings, or makeup.

Storage and Disposal

To maintain the medication's effectiveness and safety:
Store it at room temperature, avoiding freezing temperatures.
Keep the container tightly closed.
Store the medication in a dry place, avoiding bathrooms.

Missed Dose Instructions

If you miss a dose:
Apply the missed dose as soon as you remember.
If the next scheduled dose is near, skip the missed dose and resume your regular application schedule.
Do not apply two doses at once or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Use as directed by your doctor. Do not use more often or for longer than prescribed.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Apply to wet skin, lather, and rinse thoroughly. Pat skin dry.
  • Some mild dryness, redness, or peeling may occur, especially at the beginning of treatment. If severe, contact your doctor.
  • Use a non-comedogenic moisturizer if skin becomes too dry.
  • Sun sensitivity may increase; use sunscreen and protective clothing when outdoors.
  • Avoid using other harsh topical products or abrasive cleansers unless directed by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected areas 1 to 2 times daily, or as directed by a physician.

Condition-Specific Dosing:

acne vulgaris: Apply a thin layer to affected skin areas after cleansing, once or twice daily.
rosacea: Apply a thin layer to affected skin areas after cleansing, once or twice daily.
seborrheic dermatitis: Apply a thin layer to affected skin areas after cleansing, once or twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Use with caution and under medical supervision, especially in younger children)
Adolescent: Apply to affected areas 1 to 2 times daily, or as directed by a physician.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (topical use, minimal systemic absorption)
Moderate: No adjustment needed (topical use, minimal systemic absorption)
Severe: No adjustment needed (topical use, minimal systemic absorption)
Dialysis: No specific considerations (topical use, minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (topical use, minimal systemic absorption)
Moderate: No adjustment needed (topical use, minimal systemic absorption)
Severe: No adjustment needed (topical use, minimal systemic absorption)

Pharmacology

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Mechanism of Action

Sulfacetamide is a sulfonamide antibiotic that inhibits bacterial growth by interfering with the synthesis of folic acid (para-aminobenzoic acid antagonism). It also has keratolytic properties. Sulfur acts as a keratolytic agent, promoting the shedding of dead skin cells and reducing oiliness. It also possesses mild antibacterial and antifungal properties.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (topical)
Tmax: Not applicable (topical)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not applicable (topical)
ProteinBinding: Not applicable (topical)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not applicable (topical, minimal systemic absorption)
Clearance: Not applicable (topical, minimal systemic absorption)
ExcretionRoute: Not applicable (topical, minimal systemic absorption)
Unchanged: Not applicable (topical, minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Days to weeks for noticeable improvement
PeakEffect: Several weeks of consistent use
DurationOfAction: Requires continued application for sustained effect

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or 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
+ Swelling of the mouth, face, lips, tongue, or throat
Skin irritation
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
+ Symptoms may include:
- Rash
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes
- Fever, chills, or sore throat
- Cough that is new or worse
- Feeling very tired or weak
- Any bruising or bleeding
- Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
A health problem called lupus, which has been reported with similar medications, including one death. Seek medical attention if you experience:
+ A rash on your cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs

Other Possible Side Effects

Like all medications, this drug may cause side effects. While many people experience no side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Dry skin
Itching

This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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, stinging, or itching
  • Excessive redness or swelling
  • Rash or hives
  • Difficulty breathing or swallowing (signs of severe allergic reaction)
  • Worsening of skin condition
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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 symptoms you experienced.
A known sulfa allergy.
Current use of medications containing silver.
Presence of kidney disease.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health issues. Never start, stop, or adjust the dosage 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 applying this drug, avoid using it on cuts, scrapes, or damaged skin, as this can exacerbate skin irritation. Additionally, using other skin products in conjunction with this medication may increase the risk of irritation. Therefore, it is crucial to consult with your doctor before using any other drugs or products on your skin, including soaps.

Adhere to your doctor's instructions regarding the duration of use, as using this medication for an extended period beyond the recommended timeframe can worsen your skin condition. Furthermore, excessive use of this drug can lead to increased severity of your skin problem.

This medication may cause staining on clothing and fabrics, so it is advisable to take precautions to protect them from potential stains. In the event of accidental ingestion, this drug can be harmful, and you should immediately contact a doctor or a poison control center.

If you are pregnant, planning to become pregnant, or are breast-feeding, it is vital to discuss the benefits and risks associated with this medication with your doctor, as this will enable you to make an informed decision regarding its use and potential impact on you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive skin irritation (severe redness, peeling, burning)
  • If ingested (unlikely for a cleanser): Nausea, vomiting, abdominal pain, drowsiness.

What to Do:

For topical overdose, discontinue use and wash affected area with water. Apply a soothing moisturizer. For accidental ingestion, seek immediate medical attention or call Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Hypersensitivity to sulfonamides, sulfur, or any component of the formulation.
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Moderate Interactions

  • Topical products containing silver (e.g., silver sulfadiazine) - may cause discoloration.
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Minor Interactions

  • Other topical acne treatments (e.g., retinoids, benzoyl peroxide) - may increase skin irritation or dryness if used concurrently without proper guidance.

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of acne/seborrhea and identify any pre-existing irritation.

Timing: Prior to initiation of therapy

Allergy history (sulfonamides, sulfur)

Rationale: To rule out contraindications and prevent severe hypersensitivity reactions.

Timing: Prior to initiation of therapy

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Routine Monitoring

Local skin irritation (redness, dryness, peeling, burning)

Frequency: Daily, during initial treatment phase; then as needed

Target: Minimal to no irritation

Action Threshold: Moderate to severe irritation; discontinue use and consult physician

Therapeutic response (reduction in lesions, oiliness)

Frequency: Weekly to monthly

Target: Gradual improvement

Action Threshold: No improvement after 6-8 weeks; consider alternative therapy

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Symptom Monitoring

  • Excessive dryness or peeling of skin
  • Severe redness or itching
  • Burning sensation
  • Swelling of the face or throat (signs of allergic reaction)
  • Worsening of skin condition

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Sulfonamides cross the placenta. While systemic absorption from topical use is minimal, caution is advised.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with systemic sulfonamides, though minimal risk with topical use.
Second Trimester: Generally considered safer than first or third, but still use with caution.
Third Trimester: Avoid use near term (last trimester) due to theoretical risk of kernicterus in the newborn (due to displacement of bilirubin from albumin binding sites by sulfonamides), although this risk is extremely low with topical application.
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Lactation

Use with caution. Sulfonamides are excreted in breast milk. While systemic absorption from topical use is minimal, monitor the infant for signs of adverse effects (e.g., diarrhea, rash, jaundice). Avoid applying to areas where the infant may ingest the product.

Infant Risk: L3 (Moderate risk - use with caution. Monitor infant for adverse effects).
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Pediatric Use

Safety and efficacy in children under 12 years have not been fully established. Use in children should be under the direct supervision of a physician. Avoid use in infants due to theoretical risk of kernicterus with systemic sulfonamides.

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Geriatric Use

No specific dose adjustments are typically needed. However, geriatric patients may have more fragile or sensitive skin, increasing the likelihood of irritation. Use with caution and monitor for skin reactions.

Clinical Information

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Clinical Pearls

  • This product is for external use only. Do not ingest.
  • Avoid contact with eyes, mouth, and other mucous membranes. Rinse thoroughly if contact occurs.
  • Patients with a history of sulfonamide allergy should not use this product.
  • Some patients may experience a sulfur-like odor, which is normal for products containing sulfur.
  • Consistent use is key for therapeutic benefit; results may take several weeks.
  • Discontinue use and consult a physician if severe irritation or allergic reaction occurs.
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Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene)
  • Topical benzoyl peroxide
  • Topical antibiotics (e.g., clindamycin, erythromycin)
  • Oral antibiotics (e.g., doxycycline, minocycline)
  • Azelaic acid
  • Salicylic acid
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Cost & Coverage

Average Cost: Varies widely, typically $50 - $200+ per 285gm bottle
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (prescription product), may require prior authorization depending on plan
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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 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.