Sumadan 9-4.5% Wash Liquid
It is used to treat pimples (acne).It is used to treat rosacea.It is used to control seborrheic dermatitis.
Drug Class
Acne treatment, Antiseborrheic, Antibacterial (topical)
Pharmacologic Class
Sulfonamide antibiotic (Sulfacetamide), Keratolytic/Antifungal/Antibacterial (Sulfur)
Pregnancy Category
Category C (Sulfacetamide); Category B (Sulfur). Overall considered C for combination.
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This is a topical wash containing two active ingredients, sulfur and sulfacetamide, used to treat skin conditions like acne and seborrheic dermatitis. Sulfur helps to dry out and peel the skin, while sulfacetamide helps to stop the growth of bacteria.
How to Use This Medicine
Using This Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided and follow the instructions closely.
Application Instructions
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
If the medication accidentally gets on your lips or eyelids, rinse it off with water immediately.
Wash your hands thoroughly before and after applying the medication.
Apply the medication to wet skin, work it into a lather, and rinse well.
Continuing Treatment
Continue using the medication as directed by your doctor, even if your symptoms improve.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor instructs you to do so.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the lid tightly closed and store the medication in a dry place, avoiding bathrooms.
Missing a Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided and follow the instructions closely.
Application Instructions
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
If the medication accidentally gets on your lips or eyelids, rinse it off with water immediately.
Wash your hands thoroughly before and after applying the medication.
Apply the medication to wet skin, work it into a lather, and rinse well.
Continuing Treatment
Continue using the medication as directed by your doctor, even if your symptoms improve.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor instructs you to do so.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the lid tightly closed and store the medication in a dry place, avoiding bathrooms.
Missing a Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Use as directed by your doctor. Do not apply to broken or irritated skin.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- This product may cause skin dryness, redness, or peeling, especially at the beginning of treatment. If severe, reduce frequency of use or consult your doctor.
- Sulfur-containing products may have a distinct odor.
- Sulfacetamide may stain fabrics, especially light-colored ones. Rinse skin thoroughly after use.
- Use sunscreen and wear protective clothing when outdoors, as this product may increase sun sensitivity.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas 1 to 2 times daily, or as directed by physician. Lather with water, rinse thoroughly.
Condition-Specific Dosing:
acne_vulgaris:
Apply to affected areas of face, neck, and trunk.
seborrheic_dermatitis:
Apply to affected areas of scalp and skin.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult pediatrician)
Infant:
Not established (use with caution, consult pediatrician)
Child:
Generally safe for children over 12 years; for younger children, consult pediatrician. Dosing typically similar to adults.
Adolescent:
Apply a thin layer to affected areas 1 to 2 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
Sulfur acts as a keratolytic agent, promoting the shedding of dead skin cells and reducing sebum production. It also possesses antibacterial and antifungal properties. Sulfacetamide is a sulfonamide antibiotic that inhibits bacterial growth by interfering with the synthesis of folic acid (para-aminobenzoic acid antagonism). It also exhibits anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption for both components when applied topically.
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within several weeks of consistent use.
PeakEffect:
Peak therapeutic effect may take 4-8 weeks.
DurationOfAction:
Effect persists with continued use; symptoms may recur upon discontinuation.
Confidence:
Low
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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. If you experience any of the following symptoms, contact your doctor immediately:
+ Rash on your cheeks or other body parts
+ Sunburn easy
+ 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 attention:
Dry skin
* Itching
Reporting Side Effects
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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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. If you experience any of the following symptoms, contact your doctor immediately:
+ Rash on your cheeks or other body parts
+ Sunburn easy
+ 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 attention:
Dry skin
* Itching
Reporting Side Effects
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 skin irritation, redness, or burning that does not subside.
- Signs of an allergic reaction: rash, hives, itching, swelling of the face/lips/tongue, difficulty breathing (seek immediate medical attention).
- 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.
Current use of medications containing silver.
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.
Current use of medications containing silver.
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 using it on cuts, scrapes, or damaged skin, as this can exacerbate skin irritation. Additionally, be cautious when using other skin products in conjunction with this medication, as this may increase the risk of irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe use.
Do not use this medication for a longer duration than prescribed by your doctor. Overuse can worsen your skin condition. To minimize the risk of staining, take precautions to protect your clothing and fabrics, as this drug may cause discoloration.
In the event that this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as this will help you make an informed decision regarding your treatment and the well-being of your baby.
When applying this drug, avoid using it on cuts, scrapes, or damaged skin, as this can exacerbate skin irritation. Additionally, be cautious when using other skin products in conjunction with this medication, as this may increase the risk of irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor to ensure safe use.
Do not use this medication for a longer duration than prescribed by your doctor. Overuse can worsen your skin condition. To minimize the risk of staining, take precautions to protect your clothing and fabrics, as this drug may cause discoloration.
In the event that this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as this will help you make an informed decision regarding your treatment and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to severe local irritation, dryness, and peeling.
What to Do:
Discontinue use, wash affected area with water. For severe local reactions, symptomatic treatment may be needed. In case of accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Silver-containing products (e.g., silver sulfadiazine): Sulfacetamide may react with silver, potentially causing discoloration or inactivation.
Monitoring
Baseline Monitoring
Skin assessment (type, severity of lesions, presence of inflammation)
Rationale: To establish baseline for evaluating treatment efficacy and identifying potential adverse reactions.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in lesion count, inflammation)
Frequency: Every 2-4 weeks initially, then as needed
Target: Subjective improvement in skin condition
Action Threshold: Lack of improvement after 6-8 weeks, or worsening of condition, warrants re-evaluation.
Local skin irritation (redness, dryness, peeling, itching, burning)
Frequency: Daily, or as symptoms occur
Target: Minimal to no irritation
Action Threshold: Moderate to severe irritation, persistent discomfort, or signs of allergic reaction (e.g., swelling, severe rash) require discontinuation and medical evaluation.
Symptom Monitoring
- Skin dryness
- Peeling
- Redness (erythema)
- Itching (pruritus)
- Burning or stinging sensation
- Allergic reaction (rash, hives, swelling, difficulty breathing - rare but serious)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Sulfacetamide is Pregnancy Category C. While systemic absorption is minimal, caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential risk, though minimal systemic absorption limits concern.
Second Trimester:
Potential risk, though minimal systemic absorption limits concern.
Third Trimester:
Potential risk, though minimal systemic absorption limits concern. Avoid use near term due to theoretical risk of kernicterus with sulfonamides, though highly unlikely with topical use.
Lactation
Sulfacetamide is L3 (moderately safe), Sulfur is L2 (safer). Generally considered compatible with breastfeeding with caution. Avoid applying to areas where the infant may ingest the product (e.g., breast area).
Infant Risk:
Low risk of adverse effects to the infant due to minimal maternal systemic absorption. Monitor infant for diarrhea or rash.
Pediatric Use
Safety and efficacy in children under 12 years have not been fully established for all formulations. Use in younger children should be under medical supervision. Generally well-tolerated in adolescents.
Geriatric Use
No specific dosage adjustments or precautions are generally required for geriatric patients. Use with caution in patients with very sensitive or fragile skin.
Clinical Information
Clinical Pearls
- This combination is effective for both inflammatory and non-inflammatory acne, as well as seborrheic dermatitis.
- Patients should be advised that the product may have a sulfurous odor, which is normal.
- Thorough rinsing after use is crucial to prevent staining of clothing, towels, and bedding.
- Initial dryness or irritation is common; advise patients to start with once-daily application or every other day if sensitive, and gradually increase frequency as tolerated.
- Not for ophthalmic use. Avoid contact with eyes.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Salicylic acid
- Azelaic acid
- Oral antibiotics (for severe acne)
- Oral isotretinoin (for severe, recalcitrant acne)
Cost & Coverage
Average Cost:
Varies widely (e.g., $30 - $150+) per bottle (e.g., 6 oz or 16 oz)
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, typically Tier 2 or 3. May require prior authorization for some brand formulations.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.