Sumadan Kit
It is used to treat pimples (acne).It is used to treat rosacea.It is used to control seborrheic dermatitis.
Drug Class
Anti-acne agent, Anti-rosacea agent
Pharmacologic Class
Sulfonamide antibiotic (Sulfacetamide), Keratolytic/Antiseptic (Sulfur)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sumadan Kit contains two medicines, sulfur and sulfacetamide, that work together to treat skin conditions like acne and rosacea. Sulfacetamide helps stop the growth of bacteria on the skin, and sulfur helps to dry out and peel away dead skin cells, which can unclog pores.
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 as directed.
This medication is for topical use only, which means it should be applied directly to the affected skin area. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If it accidentally gets on your lips or eyelids, rinse the area with water.
Before and after applying the medication, wash your hands thoroughly.
To apply, wet the affected skin, put on the medication, work it into a lather, and then rinse well.
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.
Keep the lid tightly closed.
* Store the medication in a dry place, avoiding bathrooms.
Missed Dose
If you miss a dose, take 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 dosing schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
This medication is for topical use only, which means it should be applied directly to the affected skin area. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If it accidentally gets on your lips or eyelids, rinse the area with water.
Before and after applying the medication, wash your hands thoroughly.
To apply, wet the affected skin, put on the medication, work it into a lather, and then rinse well.
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.
Keep the lid tightly closed.
* Store the medication in a dry place, avoiding bathrooms.
Missed Dose
If you miss a dose, take 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 dosing schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Use as directed by your doctor. Do not apply to broken or irritated skin.
- Avoid contact with eyes, mouth, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Sulfur can have a distinct odor; this is normal.
- May cause skin dryness, redness, or peeling, especially at the beginning of treatment. If severe, contact your doctor.
- Use a gentle, non-comedogenic moisturizer if skin dryness occurs.
- Sun sensitivity may increase; use sunscreen and protective clothing when outdoors.
- Avoid using other topical acne treatments unless directed by your doctor, as this may increase irritation.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas 1 to 2 times daily, or as directed by physician. Typically, cleanse skin with the wash, then apply the topical lotion/cream.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
acne vulgaris:
Apply thin layer to affected areas 1-2 times daily.
rosacea:
Apply thin layer to affected areas 1-2 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in children under 12 years of age)
Adolescent:
Apply to affected areas 1 to 2 times daily, or as directed by physician (typically for ages 12 and older).
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 exerts its antibacterial effect by inhibiting the growth of susceptible bacteria (e.g., Propionibacterium acnes) by interfering with the synthesis of folic acid through competitive antagonism of para-aminobenzoic acid (PABA). It also has anti-inflammatory properties. Sulfur acts as a keratolytic agent, promoting the shedding of dead skin cells and unclogging pores. It also possesses mild antibacterial and antifungal properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<4% for sulfacetamide, even less for sulfur) when applied topically.
Tmax:
Not clinically significant for topical use.
FoodEffect:
Not applicable for topical use.
Distribution:
Vd:
Not clinically significant for topical use.
ProteinBinding:
Not clinically significant for topical use.
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not clinically significant for topical use.
Clearance:
Not clinically significant for topical use.
ExcretionRoute:
Not clinically significant for topical use.
Unchanged:
Not clinically significant for topical use.
Pharmacodynamics
OnsetOfAction:
Weeks for noticeable improvement (typically 2-4 weeks).
PeakEffect:
Several weeks to months of consistent use.
DurationOfAction:
Requires continuous application for sustained effect.
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 when taking this medication. If you notice any of the following signs or 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, 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 attention:
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 when taking this medication. If you notice any of the following signs or 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, 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 attention:
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 burning, stinging, or itching that does not subside
- Excessive redness, swelling, or peeling of the skin
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- 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 symptoms 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 in conjunction with your other treatments. 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 symptoms 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 in conjunction with your other treatments. 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 minimize the risk of 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.
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 minimize the risk of 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.
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:
- Unlikely with topical application due to minimal systemic absorption. Excessive application may lead to increased local irritation (severe redness, peeling, dryness).
What to Do:
Discontinue use and wash affected area. Symptomatic and supportive care. Call a Poison Control Center at 1-800-222-1222 for advice.
Drug Interactions
Moderate Interactions
- Silver-containing products (e.g., silver sulfadiazine, though less relevant for intact skin topical application)
- PABA-containing sunscreens (theoretical antagonism of sulfacetamide, though clinical significance for topical use is low)
Monitoring
Baseline Monitoring
Skin condition assessment (type, severity of acne/rosacea, presence of irritation)
Rationale: To establish baseline for treatment efficacy and adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (redness, dryness, peeling, itching)
Frequency: Daily, or as symptoms arise.
Target: Minimal to no irritation.
Action Threshold: Moderate to severe irritation; consider reducing frequency or discontinuing use.
Treatment efficacy (reduction in lesions, erythema)
Frequency: Monthly, or as clinically indicated.
Target: Gradual improvement in skin condition.
Action Threshold: No improvement after 6-8 weeks, or worsening of condition.
Symptom Monitoring
- Excessive dryness
- Peeling
- Redness
- Itching
- Burning sensation
- Stinging
- Allergic reactions (rash, hives, swelling)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with topical use, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Risk cannot be ruled out. Discuss with physician.
Second Trimester:
Risk cannot be ruled out. Discuss with physician.
Third Trimester:
Risk cannot be ruled out. Discuss with physician. Sulfonamides near term may theoretically increase risk of kernicterus in neonates, though systemic absorption from topical use is minimal.
Lactation
L3. Low risk. Minimal systemic absorption is expected, making transfer into breast milk unlikely to be clinically significant. Use with caution and avoid applying to areas where the infant may ingest the product.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 12 years of age. Use in adolescents (12 years and older) is common, but under medical supervision.
Geriatric Use
No specific dosage adjustments are typically required for geriatric patients. Use with caution in patients with sensitive skin, as older skin may be more prone to dryness and irritation.
Clinical Information
Clinical Pearls
- Patients should be advised that improvement may not be seen for several weeks and consistent use is key.
- The sulfur component can have a noticeable odor, which may be a concern for some patients.
- Patients with known hypersensitivity to sulfonamides or sulfur should not use this product.
- Discoloration of fabrics (especially light-colored) can occur due to the sulfur content.
- This product is for external use only. Avoid contact with eyes, mouth, and other mucous membranes.
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)
- Isotretinoin (for severe acne)
Cost & Coverage
Average Cost:
Varies widely ($50 - $300+) per kit
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often requires prior authorization for brand-name kits)
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 happened.