Sumadan Xlt 9-4.5% 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; Antiseborrheic agent
Pharmacologic Class
Sulfonamide antibiotic (sulfacetamide); Keratolytic/Antiseptic (sulfur); UV filter (sunscreen)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This kit contains a medication with sulfur and sulfacetamide, which helps treat skin conditions like acne and seborrheic dermatitis by reducing bacteria and helping skin shed dead cells. It also includes a sunscreen to protect your skin from the sun.
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.
Apply this medication to your skin only, avoiding the mouth, nose, and eyes, as it may cause burning.
If the medication accidentally gets on your lips or eyelids, rinse it off with water immediately.
Before and after applying the medication, wash your hands thoroughly.
To apply, wet your skin, put the medication on the affected area, work it into a lather, and 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 store this medication properly:
Keep it at room temperature, avoiding freezing.
Ensure the lid is tightly closed.
Store it in a dry place, avoiding bathrooms.
Missed Dose
If you miss a dose:
Apply the missed dose 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 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.
Apply this medication to your skin only, avoiding the mouth, nose, and eyes, as it may cause burning.
If the medication accidentally gets on your lips or eyelids, rinse it off with water immediately.
Before and after applying the medication, wash your hands thoroughly.
To apply, wet your skin, put the medication on the affected area, work it into a lather, and 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 store this medication properly:
Keep it at room temperature, avoiding freezing.
Ensure the lid is tightly closed.
Store it in a dry place, avoiding bathrooms.
Missed Dose
If you miss a dose:
Apply the missed dose 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.
Lifestyle & Tips
- Cleanse skin gently before applying the medication.
- Avoid contact with eyes, mouth, and mucous membranes.
- Wash hands thoroughly after application.
- Use the sunscreen cream daily, even on cloudy days, as directed.
- Avoid excessive sun exposure and use protective clothing.
- Do not use other topical medications on the same area unless directed by your doctor, as this may increase irritation.
- Be patient; it may take several weeks to see improvement.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas of the skin 1 to 3 times daily, or as directed by a physician. The sunscreen cream should be applied as directed for sun protection.
Condition-Specific Dosing:
acne_vulgaris:
Apply to clean, dry skin.
seborrheic_dermatitis:
Apply to clean, dry skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution and under medical supervision; generally not recommended for children under 12 years unless specifically prescribed.
Adolescent:
Apply a thin layer to affected areas of the skin 1 to 3 times daily, or as directed by a 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: Exerts antibacterial action by inhibiting the growth of susceptible bacteria through competitive antagonism of para-aminobenzoic acid (PABA), an essential component for bacterial synthesis of folic acid. Sulfur: Acts as a keratolytic agent, promoting the shedding of dead skin cells and unclogging pores. It also possesses mild antifungal, antibacterial, and antiparasitic properties. Sunscreen: Forms a physical barrier (e.g., zinc oxide, titanium dioxide) or chemical barrier (e.g., avobenzone, octinoxate) on the skin to absorb or reflect harmful ultraviolet (UV) radiation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (topical)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical)
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:
Days to weeks for therapeutic effect on skin conditions
PeakEffect:
Weeks to months for optimal control of skin conditions
DurationOfAction:
Dependent on continued application
Safety & Warnings
Side Effects
Serious 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)
+ 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
Most people do not experience serious side effects, and some may only have minor side effects. However, 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 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 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)
+ 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
Most people do not experience serious side effects, and some may only have minor side effects. However, 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 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 or swelling
- Worsening of skin condition
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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.
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, 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 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, 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive local irritation (severe redness, peeling, burning).
What to Do:
Discontinue use and wash the affected area thoroughly. If irritation persists, seek medical attention. In case of accidental ingestion, call a poison control center immediately (1-800-222-1222).
Drug Interactions
Moderate Interactions
- Topical silver-containing preparations (with sulfacetamide)
Minor Interactions
- Other topical acne treatments (may increase irritation)
- Abrasive soaps or cleansers
- Alcohol-containing products
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., acne lesions, seborrheic dermatitis severity)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, dryness, peeling, itching)
Frequency: Daily during initial treatment, then as needed
Target: Minimal to no irritation
Action Threshold: Moderate to severe irritation; discontinue use or reduce frequency
Therapeutic response (improvement in acne/seborrhea)
Frequency: Weekly for first month, then monthly
Target: Reduction in lesion count, decreased redness/scaling
Action Threshold: No improvement after 6-8 weeks; consider alternative therapy
Symptom Monitoring
- Excessive dryness
- Peeling
- Redness
- Itching
- Burning sensation
- Stinging
- 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, the potential for fetal exposure cannot be entirely ruled out. Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for theoretical risk, though minimal systemic absorption limits concern.
Second Trimester:
Potential for theoretical risk, though minimal systemic absorption limits concern.
Third Trimester:
Potential for theoretical risk, though minimal systemic absorption limits concern. Avoid use near term due to theoretical risk of kernicterus in neonates with systemic sulfonamides, though highly unlikely with topical use.
Lactation
Use with caution during breastfeeding. Sulfacetamide is Lactation Risk L3 (moderately safe). While systemic absorption is minimal, small amounts may be excreted in breast milk. Monitor infant for diarrhea or rash. Avoid applying to areas where the infant may ingest the medication.
Infant Risk:
Low to moderate risk of adverse effects (e.g., diarrhea, rash, theoretical risk of kernicterus in jaundiced infants) due to minimal systemic absorption.
Pediatric Use
Safety and efficacy have not been established in children under 12 years of age. Use in adolescents is generally similar to adults, but with careful monitoring for irritation.
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
- This combination product is effective for both inflammatory acne and seborrheic dermatitis.
- Patients should be advised that initial dryness or peeling is common and usually resolves with continued use or by reducing application frequency.
- The sulfur component can have a distinct odor, which some patients may find unpleasant.
- Advise patients to avoid contact with clothing or bedding, as sulfur can stain fabrics.
- The inclusion of sunscreen in the kit is beneficial, as many acne treatments can increase sun sensitivity.
- Ensure patients understand the correct application technique for each component of the kit.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Salicylic acid
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Isotretinoin (for severe acne)
Cost & Coverage
Average Cost:
Varies widely, typically $100 - $500+ per kit
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (may require prior authorization for some plans)
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.