Plexion 9.8-4.8% Cream 57gm
It is used to treat pimples (acne).It is used to treat rosacea.It is used to control seborrheic dermatitis.
Drug Class
Anti-acne agents, Antiseborrheic agents
Pharmacologic Class
Keratolytics, Sulfonamide antibiotics
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Plexion cream contains two active ingredients, sulfur and sulfacetamide, that work together to treat skin conditions like acne, rosacea, and seborrheic dermatitis. Sulfur helps to dry out and peel the skin, reducing clogged pores, while sulfacetamide helps to control 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 accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
If the medication comes into contact with your lips or eyelids, rinse the area with water immediately.
Before and after applying the medication, wash your hands thoroughly.
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 area and gently rub it in.
Continued Use and Precautions
Continue using the medication as directed, even if your symptoms improve.
Unless instructed to do so by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
Store the medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the container tightly closed to maintain the medication's potency.
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 scheduled dose, 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.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
If the medication comes into contact with your lips or eyelids, rinse the area with water immediately.
Before and after applying the medication, wash your hands thoroughly.
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 area and gently rub it in.
Continued Use and Precautions
Continue using the medication as directed, even if your symptoms improve.
Unless instructed to do so by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Storage and Disposal
Store the medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the container tightly closed to maintain the medication's potency.
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 scheduled dose, 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.
Lifestyle & Tips
- Cleanse skin gently before applying the cream.
- Apply a thin layer to affected areas, rubbing in gently until absorbed.
- Wash hands thoroughly after application.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Use sunscreen and wear protective clothing when outdoors, as this medication may increase sun sensitivity.
- Avoid using harsh cleansers, abrasive soaps, or other irritating topical products unless directed by your doctor.
- This cream may have a sulfur-like odor and can temporarily cause a yellowish discoloration of the skin or light-colored fabrics. This is usually temporary and washes off.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas 1 to 3 times daily.
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.
seborrheic dermatitis:
Apply a thin layer to affected areas 1 to 3 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (use with caution, consult pediatrician)
Adolescent:
Apply a thin layer to affected areas 1 to 3 times daily (similar to adult dosing)
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
Sulfur acts as a keratolytic agent, promoting the shedding of dead skin cells and reducing follicular occlusion. It also has mild antibacterial and antifungal properties. Sulfacetamide is a sulfonamide antibiotic that exerts a bacteriostatic effect by competitively inhibiting the enzyme dihydropteroate synthase, thereby preventing bacterial synthesis of folic acid, which is essential for bacterial growth.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<1%)
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:
Not applicable (primarily local action)
Unchanged:
Not applicable (primarily local action)
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable improvement
PeakEffect:
Weeks to months
DurationOfAction:
Dependent on continued application
Safety & Warnings
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 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)
If you experience any of the following symptoms, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your 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 has been reported with drugs like this one, resulting in one death. Seek medical attention immediately 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
Most people do not experience significant side effects, but some may occur. If you notice 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 concerns or questions, consult 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 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)
If you experience any of the following symptoms, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your 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 has been reported with drugs like this one, resulting in one death. Seek medical attention immediately 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
Most people do not experience significant side effects, but some may occur. If you notice 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 concerns or questions, consult 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 skin irritation, redness, burning, or itching that does not subside.
- Signs of an allergic reaction: rash, hives, swelling of the face/lips/tongue/throat, difficulty breathing.
- Worsening of skin condition.
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.
A known sulfa allergy.
The use of any medications containing silver.
The presence of kidney disease.
This list is not exhaustive, and it is crucial to discuss all your medications (including 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 with your other medications and health issues. Never start, stop, or adjust 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 allergic reaction you experienced.
A known sulfa allergy.
The use of any medications containing silver.
The presence of kidney disease.
This list is not exhaustive, and it is crucial to discuss all your medications (including 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 with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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.
To prevent staining, take precautions to protect your clothing and fabrics, as this drug may cause discoloration.
In the event of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center, as this drug can be harmful if swallowed.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for 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.
To prevent staining, take precautions to protect your clothing and fabrics, as this drug may cause discoloration.
In the event of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center, as this drug can be harmful if swallowed.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is vital to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely with topical application due to minimal absorption. Local overdose may lead to increased skin irritation, redness, and peeling.
What to Do:
If excessive local irritation occurs, discontinue use and wash the area. If accidental ingestion occurs, seek immediate medical attention or contact a poison control center (e.g., 1-800-222-1222).
Drug Interactions
Moderate Interactions
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Benzoyl peroxide
- Other topical drying or irritating agents
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of acne, rosacea, or seborrheic dermatitis and identify any pre-existing skin irritation or sensitivity.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin irritation (redness, dryness, peeling, burning, itching)
Frequency: Daily, or as symptoms occur
Target: Minimal to no irritation
Action Threshold: If severe or persistent irritation occurs, reduce frequency of application or discontinue use and consult physician.
Therapeutic response (reduction in lesions, erythema, scaling)
Frequency: Weekly to monthly
Target: Improvement in skin condition
Action Threshold: If no improvement after 6-8 weeks, or worsening of condition, re-evaluate diagnosis and treatment plan.
Symptom Monitoring
- Excessive skin dryness
- Peeling skin
- Redness
- Itching
- Burning sensation
- Stinging
- Unusual odor (sulfur smell)
- Yellow discoloration of skin or clothing
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, sulfonamides can cross the placenta. Discuss risks and benefits with your 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 systemic sulfonamide exposure, though topical absorption is minimal.
Lactation
L3 (Moderately safe). Minimal systemic absorption is expected, limiting infant exposure. However, sulfonamides are excreted in breast milk. Use with caution. Monitor the infant for signs of adverse effects such as diarrhea, rash, or jaundice.
Infant Risk:
Low risk, but theoretical concern for sulfonamide exposure in infants, especially those with G6PD deficiency or hyperbilirubinemia.
Pediatric Use
Safety and efficacy have been established in some pediatric populations for similar products, but specific age-group data for this exact combination may be limited. Use in children should be under the guidance of a pediatrician, especially in very young children, due to potential for increased absorption through immature skin or larger surface area to body weight ratio.
Geriatric Use
No specific dosage adjustments are typically required for geriatric patients. Use with caution in patients with very sensitive or fragile skin, as they may be more prone to irritation.
Clinical Information
Clinical Pearls
- Patients should be advised that a sulfur-like odor may be noticeable, and the cream may cause temporary yellowing of the skin or light-colored fabrics.
- It is crucial to emphasize the importance of sun protection (sunscreen, protective clothing) due to potential increased photosensitivity.
- Patients with a history of hypersensitivity to sulfonamides, sulfur, or any component of the formulation should not use this product.
- Discontinue use if excessive irritation, dryness, or allergic reactions occur.
- Results are not immediate; consistent use over several weeks to months is often required to see significant improvement.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Benzoyl peroxide
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Azelaic acid
- Metronidazole (for rosacea)
- Oral antibiotics (e.g., doxycycline, minocycline, erythromycin)
- Oral isotretinoin (for severe acne)
Cost & Coverage
Average Cost:
Not available (highly variable by brand, generic, and pharmacy) per 57gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (depends on insurance plan and formulary)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.