Silver Sulfadiazine 1% Cream 25gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical Anti-infective
Pharmacologic Class
Sulfonamide Antibiotic; Topical Anti-bacterial
Pregnancy Category
Category B (first and second trimesters), Category D (third trimester)
FDA Approved
Aug 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Silver sulfadiazine cream is a medicine applied to the skin to prevent and treat infections in severe burns. It contains a silver compound and an antibiotic (sulfadiazine) that work together to kill many types of bacteria and some fungi.
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. Use this medication only as directed, and continue to use it even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Wear protective gloves when applying the medication to prevent exposure.
Clean the affected area and remove any dead skin before applying a thin layer of the medication. Gently rub it in.
If necessary, cover the treated area with a dressing.
Storage and Disposal
Store this medication at room temperature in a dry place, away from bathrooms.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on disposal, and consider participating in local drug take-back programs.
Missed 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 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 the information provided. Use this medication only as directed, and continue to use it even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Wear protective gloves when applying the medication to prevent exposure.
Clean the affected area and remove any dead skin before applying a thin layer of the medication. Gently rub it in.
If necessary, cover the treated area with a dressing.
Storage and Disposal
Store this medication at room temperature in a dry place, away from bathrooms.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on disposal, and consider participating in local drug take-back programs.
Missed 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 once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Clean the burn wound as directed by your healthcare provider before applying the cream.
- Apply the cream using a sterile gloved hand or sterile applicator to cover the entire affected area.
- Maintain a layer of cream on the wound at all times; reapply if it rubs off.
- Keep the treated area covered with a dressing as instructed by your doctor.
- Wash your hands thoroughly before and after applying the cream.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on your face unless specifically instructed by your doctor, as it can cause temporary skin discoloration.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply 1% cream to the affected area(s) once or twice daily to a thickness of approximately 1/16 inch (1.5 mm).
Condition-Specific Dosing:
burns:
Apply to cleansed and debrided burn wounds. Reapply if removed by patient activity.
Pediatric Dosing
Neonatal:
Contraindicated in premature and full-term infants less than 2 months of age due to risk of kernicterus.
Infant:
Contraindicated in infants less than 2 months of age. For infants >2 months, use with caution and only if benefits outweigh risks, due to potential for systemic absorption and kernicterus risk.
Child:
Apply 1% cream to the affected area(s) once or twice daily to a thickness of approximately 1/16 inch (1.5 mm). Use with caution on large areas due to potential for systemic absorption.
Adolescent:
Apply 1% cream to the affected area(s) once or twice daily to a thickness of approximately 1/16 inch (1.5 mm).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment for topical use, but monitor for systemic adverse effects if applied to large areas.
Moderate:
No specific dose adjustment for topical use, but monitor for systemic adverse effects (e.g., leukopenia, crystalluria) if applied to large areas.
Severe:
No specific dose adjustment for topical use, but monitor closely for systemic adverse effects (e.g., leukopenia, crystalluria) if applied to large areas, as systemic absorption can occur and elimination may be impaired.
Dialysis:
Use with caution if applied to large areas, as systemic absorption can occur. Monitor for systemic adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment for topical use, but monitor for systemic adverse effects if applied to large areas.
Moderate:
No specific dose adjustment for topical use, but monitor for systemic adverse effects (e.g., leukopenia) if applied to large areas.
Severe:
No specific dose adjustment for topical use, but monitor closely for systemic adverse effects (e.g., leukopenia) if applied to large areas, as systemic absorption can occur and metabolism may be impaired.
Confidence:
Medium
Pharmacology
Mechanism of Action
Silver sulfadiazine exerts its bactericidal action through a dual mechanism. The silver component acts on the bacterial cell wall and membrane, causing structural damage and inhibiting DNA replication. The sulfadiazine component, a sulfonamide antibiotic, interferes with bacterial folic acid synthesis by inhibiting dihydropteroate synthase, an enzyme essential for the incorporation of para-aminobenzoic acid (PABA) into folic acid. This synergistic action provides broad-spectrum antimicrobial activity against many gram-positive and gram-negative bacteria, as well as some yeasts.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1% of silver and 10% of sulfadiazine) from intact skin. Absorption increases significantly with large burn areas or prolonged use.
Tmax:
Not well-defined for topical application; systemic peak concentrations of sulfadiazine can occur within 3-11 hours if significant absorption occurs.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application; if absorbed, sulfadiazine distributes widely into body tissues and fluids.
ProteinBinding:
Sulfadiazine: Approximately 85-90% protein bound.
CnssPenetration:
Limited for topical application; if significant systemic absorption occurs, sulfadiazine can penetrate the CNS.
Elimination:
HalfLife:
Sulfadiazine: Approximately 10 hours (if systemically absorbed).
Clearance:
Not well-defined for topical application; systemic clearance of sulfadiazine is primarily renal.
ExcretionRoute:
Sulfadiazine component and its metabolites are primarily excreted renally.
Unchanged:
Approximately 30-50% of absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid antimicrobial action upon application.
PeakEffect:
Not applicable for topical antimicrobial effect; systemic peak concentrations of sulfadiazine occur within hours if absorbed.
DurationOfAction:
Maintains antimicrobial activity as long as it remains on the wound surface, typically requiring once or twice daily 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 or seek immediate 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
Urination problems, including inability to pass urine or changes in urine output
Severe effects associated with sulfa drugs, which can be life-threatening, 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
+ New or worsening cough
+ Feeling very tired or weak
+ 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
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people 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:
Skin color changes
Skin irritation
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 immediate 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
Urination problems, including inability to pass urine or changes in urine output
Severe effects associated with sulfa drugs, which can be life-threatening, 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
+ New or worsening cough
+ Feeling very tired or weak
+ 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
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people 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:
Skin color changes
Skin irritation
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 skin rash, blistering, or peeling (could be a sign of a serious skin reaction like Stevens-Johnson syndrome)
- Fever, chills, sore throat, or unusual tiredness (could be signs of a blood disorder like low white blood cell count)
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Unusual bleeding or bruising
- Painful urination or blood in urine
- Signs of worsening infection (increased redness, swelling, pus, pain, or foul odor from the wound)
- Allergic reactions such as hives, difficulty breathing, swelling of your face, lips, tongue, or 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. Describe the symptoms you experienced with the allergy.
A known sulfa allergy.
If you are pregnant, especially near term.
For Parents or Caregivers:
If your child is a premature baby or a newborn, do not administer this medication. It is not suitable for premature babies or newborns.
If your child is under 2 months of age, do not give them this medication. It is not recommended for infants younger than 2 months old.
Potential Interactions:
This medication may interact with other medications or health conditions. Therefore, it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist.
* To ensure safe use, verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without 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. Describe the symptoms you experienced with the allergy.
A known sulfa allergy.
If you are pregnant, especially near term.
For Parents or Caregivers:
If your child is a premature baby or a newborn, do not administer this medication. It is not suitable for premature babies or newborns.
If your child is under 2 months of age, do not give them this medication. It is not recommended for infants younger than 2 months old.
Potential Interactions:
This medication may interact with other medications or health conditions. Therefore, it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist.
* To ensure safe use, verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without 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.
If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you should exercise caution, as this condition may increase your risk of developing anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low levels of G6PD.
This medication can increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to sunlight, and notify your doctor if you experience easy sunburning while taking this drug.
Do not use this medication for a longer duration than prescribed, as this may lead to the development of a secondary infection.
In the event that this medication is ingested, it can cause harm. If accidental ingestion occurs, immediately contact a doctor or a poison control center.
This medication may interfere with certain laboratory tests. Ensure that your doctor and laboratory personnel are aware that you are using this drug to avoid any potential complications.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you should exercise caution, as this condition may increase your risk of developing anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low levels of G6PD.
This medication can increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to sunlight, and notify your doctor if you experience easy sunburning while taking this drug.
Do not use this medication for a longer duration than prescribed, as this may lead to the development of a secondary infection.
In the event that this medication is ingested, it can cause harm. If accidental ingestion occurs, immediately contact a doctor or a poison control center.
This medication may interfere with certain laboratory tests. Ensure that your doctor and laboratory personnel are aware that you are using this drug to avoid any potential complications.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application unless ingested or applied to very large areas for prolonged periods.
- Symptoms of systemic absorption could include: nausea, vomiting, diarrhea, headache, dizziness, confusion, fever, skin rash, yellowing of skin/eyes, dark urine, blood disorders (e.g., low white blood cell count, low platelet count), kidney problems (e.g., crystalluria, kidney failure).
What to Do:
If overdose is suspected, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive and symptomatic. Discontinue use, ensure adequate hydration to prevent crystalluria, and monitor blood counts and renal function.
Drug Interactions
Contraindicated Interactions
- Enzymatic debriding agents (e.g., collagenase, papain, sutilains) - Silver can inactivate these enzymes.
Moderate Interactions
- Cimetidine (potential for increased leukopenia, especially in burn patients)
- Phenytoin (potential for increased phenytoin levels if significant sulfadiazine absorption occurs)
- Warfarin (potential for increased anticoagulant effect if significant sulfadiazine absorption occurs)
- Methotrexate (potential for increased methotrexate toxicity if significant sulfadiazine absorption occurs)
- Oral hypoglycemics (sulfonylureas) (potential for increased hypoglycemic effect if significant sulfadiazine absorption occurs)
Monitoring
Baseline Monitoring
Wound assessment (size, depth, infection signs)
Rationale: To establish baseline for treatment efficacy and identify potential complications.
Timing: Prior to first application.
Complete Blood Count (CBC) with differential
Rationale: To establish baseline, as leukopenia (including agranulocytosis) is a known adverse effect of sulfonamides, especially with extensive absorption.
Timing: Prior to initiation, especially for large burn areas.
Renal function (BUN, creatinine)
Rationale: To assess baseline renal function, as sulfadiazine is renally excreted and crystalluria can occur.
Timing: Prior to initiation, especially for large burn areas or patients with pre-existing renal impairment.
Routine Monitoring
Wound healing progress
Frequency: Daily or with each dressing change
Target: Reduction in wound size, decreased exudate, healthy granulation tissue
Action Threshold: Lack of improvement, worsening infection, signs of systemic infection
Signs of local adverse reactions (e.g., rash, itching, burning)
Frequency: Daily or with each dressing change
Target: Absence of new or worsening skin irritation
Action Threshold: Development of severe rash, blistering, or signs of hypersensitivity
Complete Blood Count (CBC) with differential
Frequency: Twice weekly (especially for large burns or prolonged use)
Target: WBC count within normal limits (e.g., >4,000 cells/mm³)
Action Threshold: Significant drop in WBC count (<3,000 cells/mm³), particularly neutropenia
Renal function (BUN, creatinine)
Frequency: Weekly (especially for large burns or prolonged use)
Target: Within normal limits
Action Threshold: Significant increase in BUN/creatinine, signs of crystalluria
Symptom Monitoring
- Fever
- Chills
- Sore throat (signs of infection or myelosuppression)
- Unusual bleeding or bruising (signs of hematologic abnormalities)
- Skin rash, itching, hives, blistering (signs of hypersensitivity or Stevens-Johnson syndrome)
- Nausea, vomiting, diarrhea
- Dark urine, yellowing of skin/eyes (signs of hepatic dysfunction or hemolysis)
- Painful urination, blood in urine (signs of crystalluria)
- Signs of superinfection (e.g., fungal growth)
Special Patient Groups
Pregnancy
Category B in the first and second trimesters. Category D in the third trimester. Avoid use in late pregnancy (third trimester) due to the risk of kernicterus in the newborn, as sulfonamides can displace bilirubin from albumin binding sites.
Trimester-Specific Risks:
First Trimester:
Low risk, generally considered safe.
Second Trimester:
Low risk, generally considered safe.
Third Trimester:
High risk. Contraindicated due to potential for kernicterus in the newborn.
Lactation
Use with caution. Sulfonamides are excreted in breast milk. Avoid use in premature infants, infants with hyperbilirubinemia, or infants with G6PD deficiency due to the risk of kernicterus or hemolytic anemia.
Infant Risk:
L3 (Moderately Safe) - Potential for kernicterus or hemolytic anemia in susceptible infants. Monitor infant for jaundice, lethargy, or poor feeding.
Pediatric Use
Contraindicated in premature and full-term infants less than 2 months of age due to the risk of kernicterus. Use with caution in older infants and children, especially on large body surface areas, due to the potential for systemic absorption and associated sulfonamide adverse effects (e.g., leukopenia, crystalluria).
Geriatric Use
Generally safe for use in geriatric patients. However, monitor for systemic adverse effects (e.g., leukopenia, renal impairment) if applied to large areas, especially in patients with pre-existing renal or hepatic dysfunction.
Clinical Information
Clinical Pearls
- Always apply silver sulfadiazine cream using sterile technique (e.g., sterile gloves, sterile applicator) to prevent contamination of the burn wound.
- Ensure the cream is applied in a continuous layer over the entire burn surface; reapply if it is removed by patient activity or bathing.
- Monitor for signs of systemic absorption, especially leukopenia, which can occur within 2-4 days of initiation and usually resolves spontaneously upon discontinuation.
- Hydration is crucial for patients with burns, and also helps minimize the risk of crystalluria if systemic absorption of sulfadiazine occurs.
- Silver sulfadiazine can cause a transient blue-gray discoloration of the skin, especially with prolonged use or exposure to light.
- Do not use concurrently with enzymatic debriding agents, as silver can inactivate them.
- Consider alternative treatments if the patient develops a severe allergic reaction or significant systemic adverse effects.
Alternative Therapies
- Mafenide acetate (Sulfamylon) cream/solution (another topical sulfonamide for burns)
- Bacitracin ointment
- Polymyxin B sulfate/Bacitracin zinc ointment
- Povidone-iodine solution/ointment
- Topical antibiotics (e.g., mupirocin, neomycin/polymyxin B/bacitracin)
- Honey-based dressings
- Advanced wound care dressings (e.g., silver-impregnated dressings, hydrogels, hydrocolloids)
Cost & Coverage
Average Cost:
$15 - $40 per 25gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 for more information. If you have any questions or concerns about this 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 occurred.