Plexion 9.8-4.8% Lotion 57gm
It is used to treat pimples (acne).It is used to treat rosacea.It is used to control seborrheic dermatitis.
Drug Class
Acne and Rosacea Agents
Pharmacologic Class
Topical Antibacterial (Sulfacetamide) & Keratolytic/Antiseptic (Sulfur)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This lotion contains two active ingredients, sulfur and sulfacetamide, that work together to treat skin conditions like acne and rosacea. Sulfur helps to dry out and peel away dead skin cells, while sulfacetamide is an antibiotic that helps to stop the growth of bacteria on the skin.
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 area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the area with water.
Before applying the medication, wash your hands thoroughly. Clean the affected area and make sure it is completely dry. Then, apply a thin layer of the medication to the affected area and gently rub it in.
Continue using the medication as directed by your doctor, even if your symptoms improve. Unless instructed otherwise by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature, away from freezing temperatures. Keep the container tightly closed and store it in a dry place, avoiding bathrooms.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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 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 area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the area with water.
Before applying the medication, wash your hands thoroughly. Clean the affected area and make sure it is completely dry. Then, apply a thin layer of the medication to the affected area and gently rub it in.
Continue using the medication as directed by your doctor, even if your symptoms improve. Unless instructed otherwise by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature, away from freezing temperatures. Keep the container tightly closed and store it in a dry place, avoiding bathrooms.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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 one.
Lifestyle & Tips
- Cleanse skin gently before application.
- Apply a thin layer to affected areas; do not rub in vigorously.
- Avoid contact with eyes, mouth, and mucous membranes.
- Wash hands thoroughly after application.
- Use sunscreen daily, as sulfur can increase sun sensitivity.
- Avoid using other topical acne treatments concurrently unless directed by a doctor, to prevent excessive irritation.
- Be aware of the characteristic odor of sulfur.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas 1 to 3 times daily, or as directed by physician.
Dose Range:
1 - 3 mg
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to affected areas 1 to 3 times daily.
rosacea:
Apply a thin layer to affected areas 1 to 3 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established; use with caution and under medical supervision, typically for children 12 years and older.
Adolescent:
Apply a thin layer to affected areas 1 to 3 times daily, or as directed by physician.
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
Sulfacetamide: A sulfonamide antibiotic that competitively inhibits bacterial dihydropteroate synthase, an enzyme essential for bacterial synthesis of folic acid from para-aminobenzoic acid (PABA). This bacteriostatic action prevents bacterial growth. Sulfur: Acts as a keratolytic agent, promoting the shedding of dead skin cells and unclogging pores. It also has mild antiseptic, antifungal, and antibacterial properties, particularly against P. acnes.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical application)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Primarily local action; any absorbed sulfacetamide is renally excreted.
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement in skin condition.
PeakEffect:
Weeks to months of consistent use.
DurationOfAction:
Dependent on continued application.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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, 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
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 worsening
- 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 drugs like this one. One death has been associated with this condition. If you experience any of the following symptoms, contact your doctor immediately:
+ 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 in some people. While many individuals may not experience any 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 symptoms that bother you or do not go away, contact your doctor:
Dry skin
Itching
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns 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, some people may experience severe and potentially life-threatening side effects while 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, 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
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 worsening
- 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 drugs like this one. One death has been associated with this condition. If you experience any of the following symptoms, contact your doctor immediately:
+ 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 in some people. While many individuals may not experience any 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 symptoms that bother you or do not go away, contact your doctor:
Dry skin
Itching
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns 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 burning, stinging, or itching after application
- Excessive redness, dryness, or peeling that does not improve
- Worsening of skin condition
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Unusual skin discoloration
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.
A known sulfa allergy, as this may affect your ability to take this medication.
The use of any medications containing silver, as this may interact with this drug.
The presence of kidney disease, as this may impact the safety and effectiveness of this medication.
This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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.
A known sulfa allergy, as this may affect your ability to take this medication.
The use of any medications containing silver, as this may interact with this drug.
The presence of kidney disease, as this may impact the safety and effectiveness of this medication.
This list is not exhaustive, and it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 putting it on cuts, scrapes, or damaged skin, as this can exacerbate skin irritation. Additionally, using other skin products concurrently 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 drug for an extended period beyond the recommended timeframe can worsen your skin condition.
Be aware that this drug may cause staining on clothing and fabrics, so take necessary precautions to protect them.
In the event of accidental ingestion, this drug can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for both you and your baby.
When applying this drug, avoid putting it on cuts, scrapes, or damaged skin, as this can exacerbate skin irritation. Additionally, using other skin products concurrently 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 drug for an extended period beyond the recommended timeframe can worsen your skin condition.
Be aware that this drug may cause staining on clothing and fabrics, so take necessary precautions to protect them.
In the event of accidental ingestion, this drug can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Local symptoms may include severe irritation, redness, and peeling.
What to Do:
Discontinue use, wash affected area thoroughly with water. For severe local reactions, seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Topical PABA-containing sunscreens (may inactivate sulfacetamide)
Monitoring
Routine Monitoring
Skin irritation (redness, dryness, peeling)
Frequency: Daily, during initial treatment
Target: Minimal to none
Action Threshold: If severe or persistent irritation occurs, reduce frequency or discontinue use and consult physician.
Therapeutic response (reduction in lesions, inflammation)
Frequency: Weekly to monthly
Target: Improvement in skin condition
Action Threshold: If no improvement after several weeks, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Excessive dryness
- Peeling
- Redness
- Itching
- Burning sensation
- Allergic reactions (rash, hives, swelling)
Special Patient Groups
Pregnancy
Use with caution during pregnancy. Sulfacetamide is Pregnancy Category C. While systemic absorption from topical application is minimal, sulfonamides can cross the placenta. Discuss risks vs. benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential theoretical risk, but minimal systemic absorption limits concern.
Second Trimester:
Potential theoretical risk, but minimal systemic absorption limits concern.
Third Trimester:
Avoid use near term due to theoretical risk of kernicterus in neonates with sulfonamide exposure, although risk from topical application is extremely low.
Lactation
Use with caution during breastfeeding. Sulfacetamide is Lactation Risk L3 (moderately safe). While minimal systemic absorption is expected, small amounts may be excreted in breast milk. Monitor infant for diarrhea, rash, or jaundice. Avoid applying to areas where infant may ingest the product.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption, but theoretical risk of sulfonamide-related effects (e.g., jaundice) in sensitive infants.
Pediatric Use
Safety and efficacy not fully established in children under 12 years. Use with caution and under medical supervision in adolescents. Children may be more susceptible to skin irritation.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients, given minimal systemic absorption. However, older adults may have more fragile skin and be more prone to irritation.
Clinical Information
Clinical Pearls
- This combination product is effective for both inflammatory acne and rosacea due to its antibacterial and anti-inflammatory properties.
- Patients should be advised about the characteristic sulfur odor, which can be noticeable.
- Instruct patients to apply a very thin layer to avoid excessive drying or irritation.
- Emphasize the importance of consistent use for optimal results, which may take several weeks.
- Advise patients to avoid contact with eyes, as it can cause irritation.
- Patients with a known sulfonamide allergy should not use this product.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline) for severe cases
- Isotretinoin (for severe, recalcitrant acne)
Cost & Coverage
Average Cost:
Varies, typically $50-$200 per 57gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often covered by most plans, especially generics)
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 your 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 medication taken, the amount, and the time it happened.