Silver Sulfadiazine 1% Cream 85gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical anti-infective, burn treatment
Pharmacologic Class
Sulfonamide derivative, topical antimicrobial
Pregnancy Category
Category B (1st & 2nd trimesters), Category D (3rd trimester/near term)
FDA Approved
Sep 1968
DEA Schedule
Not Controlled
Overview
What is this medicine?
Silver sulfadiazine is an antibiotic cream used to prevent and treat infections in severe burns. It works by killing bacteria and some fungi that can cause infections in burn wounds.
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, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before and after applying the medication, wash your hands thoroughly. However, if your hand is the treated area, do 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 the bathroom.
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 the best disposal method. You may also want to check if there are drug take-back programs in your area.
Missed Dose
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 the same time or use extra doses to make up for a missed one.
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, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before and after applying the medication, wash your hands thoroughly. However, if your hand is the treated area, do 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 the bathroom.
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 the best disposal method. You may also want to check if there are drug take-back programs in your area.
Missed Dose
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 the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Always wash your hands thoroughly before and after applying the cream.
- Use sterile gloves when applying the cream to the burn area.
- Apply the cream directly to the burn wound, ensuring it is covered at all times. Reapply if the cream is rubbed off or washed away.
- Keep the burn area clean and follow your healthcare provider's instructions for dressing changes.
- Avoid getting the cream in your eyes. If it gets into your eyes, rinse thoroughly with water.
- Do not use this cream for any other skin conditions unless directed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to a thickness of approximately 1/16 inch (1.5 mm) once or twice daily.
Condition-Specific Dosing:
burns:
Apply to the affected burn area once or twice daily, ensuring the burn is covered at all times. Reapply if removed by patient activity or hydrotherapy.
Pediatric Dosing
Neonatal:
Contraindicated in premature infants and neonates (0-2 months) due to risk of kernicterus.
Infant:
Contraindicated in infants <2 months. For infants >2 months, use with caution; dosing similar to adult, but monitor for systemic absorption.
Child:
Dosing similar to adult, apply to affected burn area once or twice daily. Use with caution, especially with extensive burns, due to potential for systemic absorption.
Adolescent:
Dosing similar to adult, apply to affected burn area once or twice daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for topical use, but monitor for systemic effects if extensive burns.
Moderate:
No specific adjustment for topical use, but monitor for systemic effects (e.g., sulfadiazine accumulation, blood dyscrasias) if extensive burns or prolonged use.
Severe:
Use with caution; monitor for systemic effects and consider alternative if extensive burns, due to potential for sulfadiazine accumulation.
Dialysis:
Considerations: Systemic absorption is limited, but if significant absorption occurs, sulfadiazine is dialyzable. Monitor closely.
Hepatic Impairment:
Mild:
No specific adjustment for topical use.
Moderate:
No specific adjustment for topical use, but monitor for systemic effects if extensive burns or prolonged use.
Severe:
Use with caution; monitor for systemic effects if extensive burns, as sulfadiazine is metabolized in the liver.
Pharmacology
Mechanism of Action
Silver sulfadiazine dissociates to release silver ions and sulfadiazine. Silver ions exert antimicrobial effects by binding to bacterial cell walls and membranes, disrupting their integrity and inhibiting DNA replication. Sulfadiazine, a sulfonamide, interferes with bacterial folic acid synthesis by competing with para-aminobenzoic acid (PABA), an essential component for bacterial growth. The combination provides broad-spectrum activity against Gram-positive and Gram-negative bacteria, and some fungi.
Pharmacokinetics
Absorption:
Bioavailability:
Limited systemic absorption (1-10% of sulfadiazine, <1% of silver) from intact skin; can increase significantly with extensive burns or damaged skin.
Tmax:
Not well-defined for topical application; systemic peak concentrations of sulfadiazine, if absorbed, typically occur within 3-11 hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-quantified for topical application; systemically absorbed sulfadiazine distributes into body fluids and tissues.
ProteinBinding:
Sulfadiazine is highly protein-bound (40-80%) in plasma.
CnssPenetration:
Limited (for systemically absorbed sulfadiazine, can cross blood-brain barrier to some extent).
Elimination:
HalfLife:
Approximately 10 hours (for systemically absorbed sulfadiazine).
Clearance:
Not well-quantified for topical application; primarily renal for absorbed sulfadiazine.
ExcretionRoute:
Primarily renal excretion (unchanged drug and metabolites) for systemically absorbed sulfadiazine.
Unchanged:
Approximately 60-85% of absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid antimicrobial action upon contact with the wound surface.
PeakEffect:
Continuous antimicrobial activity as long as the cream is present on the wound.
DurationOfAction:
Maintained as long as the cream is applied and covers the wound (typically 12-24 hours per 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. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could indicate a serious reaction:
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
Difficulty urinating or changes in urine output
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
+ New or worsening cough
+ Feeling extremely 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. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Changes in skin color
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. Immediately contact your doctor or seek medical attention if you notice any of the following symptoms, which could indicate a serious reaction:
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
Difficulty urinating or changes in urine output
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
+ New or worsening cough
+ Feeling extremely 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. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Changes in skin color
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, itching, or hives
- Fever, chills, or sore throat (signs of infection or blood problems)
- Unusual bleeding or bruising
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Severe nausea, vomiting, or abdominal pain
- Signs of kidney problems (e.g., decreased urination, swelling in ankles/feet)
- Bluish discoloration of skin or lips (rare, but can indicate methemoglobinemia)
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 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 inform your doctor and pharmacist about:
+ All prescription and over-the-counter (OTC) medications you are taking.
+ Any natural products or vitamins you are using.
+ Existing health problems.
* Before taking this medication, verify that it is safe to use with your other medications and health conditions. Do not start, stop, or change the dosage 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 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 inform your doctor and pharmacist about:
+ All prescription and over-the-counter (OTC) medications you are taking.
+ Any natural products or vitamins you are using.
+ Existing health problems.
* Before taking this medication, verify that it is safe to use with your other medications and health conditions. Do not start, stop, or change the dosage 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 you may be at a higher risk of developing anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low G6PD levels.
When taking this medication, be aware that you may be more susceptible to sunburn. Take necessary precautions when exposed to the sun, and notify your doctor if you experience increased sensitivity to sunlight.
Do not use this medication for a longer duration than prescribed, as this may increase the risk 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 taking this medication to avoid any potential interactions.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
When taking this medication, be aware that you may be more susceptible to sunburn. Take necessary precautions when exposed to the sun, and notify your doctor if you experience increased sensitivity to sunlight.
Do not use this medication for a longer duration than prescribed, as this may increase the risk 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 taking this medication to avoid any potential interactions.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic overdose is unlikely with topical application due to limited absorption.
- If significant absorption occurs (e.g., from very extensive burns), symptoms could include nausea, vomiting, diarrhea, headache, dizziness, crystalluria, blood dyscrasias (leukopenia, thrombocytopenia, hemolytic anemia), and renal impairment.
What to Do:
If accidental ingestion or significant systemic absorption is suspected, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, including hydration to prevent crystalluria, and monitoring of blood counts and renal function.
Drug Interactions
Major Interactions
- Enzymatic debriding agents (e.g., collagenase, papain, sutilains): Silver can inactivate these enzymes, rendering them ineffective. Avoid concomitant use.
Moderate Interactions
- Cimetidine: Concomitant use with silver sulfadiazine has been associated with an increased incidence of leukopenia.
- Oral hypoglycemics (sulfonylureas): If significant systemic absorption of sulfadiazine occurs, there is a theoretical risk of enhanced hypoglycemic effect.
- Phenytoin: If significant systemic absorption of sulfadiazine occurs, there is a theoretical risk of increased phenytoin levels due to protein binding displacement or metabolic inhibition.
- Warfarin: If significant systemic absorption of sulfadiazine occurs, there is a theoretical risk of enhanced anticoagulant effect.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline values, especially white blood cell (WBC) count, as leukopenia is a known adverse effect.
Timing: Prior to initiation of therapy, especially for extensive burns.
Renal function (BUN, creatinine)
Rationale: To assess baseline renal function, as sulfadiazine is renally excreted and impaired function can increase systemic exposure.
Timing: Prior to initiation of therapy, especially for extensive burns or patients with pre-existing renal impairment.
Routine Monitoring
Wound appearance and healing progress
Frequency: Daily
Target: Signs of infection resolution, granulation tissue formation, wound closure.
Action Threshold: Worsening infection, delayed healing, signs of systemic infection (fever, chills).
Complete Blood Count (CBC) with differential
Frequency: Weekly or bi-weekly, especially during prolonged therapy or extensive burns.
Target: WBC count within normal limits (e.g., >4,000 cells/mm³).
Action Threshold: Significant drop in WBC count (<2,000-3,000 cells/mm³), especially neutropenia, may warrant discontinuation or dose adjustment.
Renal function (BUN, creatinine)
Frequency: Periodically, especially with extensive burns or pre-existing renal impairment.
Target: Within normal limits.
Action Threshold: Significant increase in BUN/creatinine, indicating renal impairment.
Symptom Monitoring
- Local skin reactions (pain, burning, itching, rash, discoloration)
- Signs of systemic infection (fever, chills, malaise)
- Signs of sulfa-related adverse effects (skin rash, itching, sore throat, fever, unusual bleeding or bruising, jaundice, dark urine, severe nausea/vomiting, abdominal pain)
- Signs of methemoglobinemia (cyanosis, shortness of breath, fatigue) - rare but possible with extensive absorption.
Special Patient Groups
Pregnancy
Category B for first and second trimesters; Category D for third trimester/near term. Avoid use in the third trimester or near term due to the risk of kernicterus in the neonate (sulfonamide component). Use only if the potential benefit justifies the potential risk to the fetus in early pregnancy.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk. Category B.
Second Trimester:
Limited data, but generally considered low risk. Category B.
Third Trimester:
High risk. Contraindicated near term due to the risk of kernicterus in the neonate (sulfonamide displaces bilirubin from albumin). Category D.
Lactation
L3 (Moderate risk). Sulfadiazine is excreted in breast milk. Avoid use if the infant is premature, G6PD deficient, hyperbilirubinemic, or ill, due to the risk of kernicterus. Use with caution in healthy, full-term infants, and monitor for adverse effects.
Infant Risk:
Risk of kernicterus in susceptible infants (premature, G6PD deficient, hyperbilirubinemic). Potential for allergic reactions in infants with sulfa allergy.
Pediatric Use
Contraindicated in premature infants and neonates (0-2 months) due to the risk of kernicterus. Use with caution in older children, especially with extensive burns, due to the potential for increased systemic absorption and associated adverse effects (e.g., blood dyscrasias, renal toxicity).
Geriatric Use
Use with caution, especially in elderly patients with pre-existing renal impairment, as systemic absorption of sulfadiazine can occur, leading to accumulation and increased risk of adverse effects (e.g., blood dyscrasias, renal toxicity). Monitor renal function and CBC.
Clinical Information
Clinical Pearls
- Silver sulfadiazine cream should be applied with a sterile gloved hand to prevent contamination.
- It is crucial to maintain a continuous layer of cream over the burn wound at all times. Reapply if the cream is removed by patient activity or hydrotherapy.
- The cream may cause a transient burning sensation or pain upon application.
- Prolonged use or application to extensive areas may lead to systemic absorption of sulfadiazine, requiring monitoring of blood counts (especially WBC) and renal function.
- Temporary grayish discoloration of the skin may occur due to silver deposition, especially with prolonged use.
- Not for ophthalmic use. Avoid contact with eyes.
- Patients with a history of sulfa allergy should be monitored closely for hypersensitivity reactions, although topical application generally carries a lower risk than systemic administration.
Alternative Therapies
- Mafenide acetate (Sulfamylon) cream: Another topical sulfonamide for burn treatment, penetrates eschar better but can cause pain and metabolic acidosis.
- Topical antibiotics (e.g., bacitracin, polymyxin B, mupirocin) for superficial wounds or specific infections.
- Systemic antibiotics: For deep or extensive burn infections, or when topical therapy is insufficient.
- Honey-based dressings: Emerging alternative for wound healing and antimicrobial properties.
Cost & Coverage
Average Cost:
$15 - $50 per 85gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic usually preferred)
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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.