Silvadene 1% Cream 25gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Anti-infective, Topical
Pharmacologic Class
Sulfonamide, Topical
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 is a cream used 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, helping the burn wound heal.
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. If you have questions, consult your pharmacist. 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 dose, skip the missed dose and resume your regular schedule.
Do not apply 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, 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. If you have questions, consult your pharmacist. 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 dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or take extra doses.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the cream.
- Clean the burn wound as directed by your healthcare provider before applying the cream.
- Apply a thin layer of cream (about 1/16 inch thick) to cover the entire burn surface.
- Keep the burn wound covered with cream at all times. Reapply if the cream rubs off or is washed away.
- Do not apply to the eyes.
- Avoid exposure to sunlight or tanning beds while using this cream, as it may cause photosensitivity (increased sensitivity to sun).
- Stay well-hydrated to help prevent kidney problems, especially if using on large areas.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply 1% cream to the affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm). The burn wound should be covered with cream at all times.
Condition-Specific Dosing:
burn_wounds:
Apply 1% cream to the affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm). The burn wound should be covered with cream at all times. Reapply immediately if removed by patient activity.
Pediatric Dosing
Neonatal:
Contraindicated in premature infants and neonates 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 once or twice daily to a thickness of approximately 1/16 inch (1.5 mm). The burn wound should be covered with cream at all times. Use with caution, especially in children with G6PD deficiency.
Adolescent:
Apply 1% cream to the affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm). The burn wound should be covered with cream at all times.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment for topical use, but use with caution due to potential for systemic absorption of sulfadiazine and silver, especially with large surface area burns or prolonged use.
Moderate:
Use with caution; monitor for signs of systemic toxicity (e.g., leukopenia, crystalluria). Consider temporary discontinuation if renal function significantly declines or if systemic adverse effects occur.
Severe:
Use with extreme caution or avoid, especially in patients with severe renal impairment, due to increased risk of systemic accumulation of sulfadiazine and silver. Monitor closely for adverse effects.
Dialysis:
Not well studied for topical use. Systemic absorption is minimal but possible. If significant absorption occurs, sulfadiazine is dialyzable. Consult with nephrologist.
Hepatic Impairment:
Mild:
No specific dose adjustment for topical use, but use with caution.
Moderate:
Use with caution; monitor for signs of systemic toxicity. Sulfadiazine is metabolized in the liver.
Severe:
Use with caution or avoid in severe hepatic impairment, as metabolism of sulfadiazine may be impaired, increasing risk of systemic accumulation and toxicity.
Pharmacology
Mechanism of Action
Silver sulfadiazine acts on the bacterial cell wall and cell membrane. The silver component is released slowly and exerts an antiseptic effect by binding to bacterial DNA and proteins, disrupting cell integrity and metabolism. The sulfadiazine component, a sulfonamide, interferes with bacterial folic acid synthesis by inhibiting dihydropteroate synthase, a competitive antagonist of para-aminobenzoic acid (PABA), which is essential for bacterial growth. This dual mechanism 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 surface area burns or prolonged use.
Tmax:
Not well-defined for topical application; systemic peak concentrations of sulfadiazine typically occur within 3-11 hours if significant absorption occurs.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application. Systemically absorbed sulfadiazine distributes widely into body tissues and fluids.
ProteinBinding:
Sulfadiazine is approximately 85-90% protein bound.
CnssPenetration:
Limited for topical application. Systemically absorbed sulfadiazine can penetrate the CNS, especially in the presence of inflamed meninges.
Elimination:
HalfLife:
Systemically absorbed sulfadiazine has a half-life of approximately 10 hours (range 6-12 hours).
Clearance:
Not well-defined for topical application. Systemic clearance of sulfadiazine is primarily renal.
ExcretionRoute:
Primarily renal excretion (unchanged drug and metabolites) for systemically absorbed sulfadiazine and silver.
Unchanged:
Approximately 50-60% of systemically absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Immediate upon application (local antimicrobial effect).
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 requiring once or twice daily application.
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
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, 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. Many people may not experience any side effects or may only have mild ones. If you are concerned about any of the following side effects or if they persist, contact your doctor:
Changes in skin color
Skin irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. For medical advice 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.
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
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, 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. Many people may not experience any side effects or may only have mild ones. If you are concerned about any of the following side effects or if they persist, contact your doctor:
Changes in skin color
Skin irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. For medical advice 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:
- Signs of infection getting worse (increased redness, swelling, pain, pus, fever, chills)
- New rash, itching, or hives (signs of allergic reaction)
- Unusual tiredness, weakness, pale skin, sore throat, or fever (signs of blood problems)
- Yellowing of skin or eyes (jaundice)
- Dark urine or decreased urination (signs of kidney problems)
- Bluish-gray discoloration of skin (rare, but can indicate silver accumulation)
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 during an allergic reaction.
A known sulfa allergy.
If you are pregnant, especially near term.
For children:
+ If your child is a premature baby or a newborn, as this medication is not suitable for them.
+ If your child is under 2 months of age, as this medication should not be given to infants younger than 2 months.
Additionally, this medication may interact with other medications or health conditions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have.
* Before starting, stopping, or changing the dose of any medication, consult with your doctor to ensure it is safe to do so in combination with this medication.
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 during an allergic reaction.
A known sulfa allergy.
If you are pregnant, especially near term.
For children:
+ If your child is a premature baby or a newborn, as this medication is not suitable for them.
+ If your child is under 2 months of age, as this medication should not be given to infants younger than 2 months.
Additionally, this medication may interact with other medications or health conditions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have.
* Before starting, stopping, or changing the dose of any medication, consult with your doctor to ensure it is safe to do so in combination with this medication.
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. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low levels of G6PD, which may increase the risk of developing anemia.
This medication can increase your sensitivity to sunlight, making you more prone to sunburn. Take necessary precautions when exposed to the sun, and notify your doctor if you experience excessive sunburn while taking this drug.
Do not use this medication for a longer duration than prescribed, as this may lead to a secondary infection.
In the event that this medication is ingested, it can cause harm. If swallowed, 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.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you should exercise caution. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low levels of G6PD, which may increase the risk of developing anemia.
This medication can increase your sensitivity to sunlight, making you more prone to sunburn. Take necessary precautions when exposed to the sun, and notify your doctor if you experience excessive sunburn while taking this drug.
Do not use this medication for a longer duration than prescribed, as this may lead to a secondary infection.
In the event that this medication is ingested, it can cause harm. If swallowed, 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.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- While systemic overdose from topical application is rare, extensive absorption could lead to symptoms of systemic sulfonamide toxicity: nausea, vomiting, diarrhea, abdominal pain, headache, dizziness, confusion, crystalluria, blood dyscrasias (e.g., leukopenia, thrombocytopenia, hemolytic anemia), and liver dysfunction.
What to Do:
Discontinue use immediately. Seek emergency medical attention. Treatment is supportive and symptomatic. Ensure adequate hydration to prevent crystalluria. Dialysis may be considered in severe cases of systemic absorption and toxicity. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Enzymatic debriding agents (e.g., collagenase, papain, sutilains) - silver can inactivate these enzymes.
Major Interactions
- Not applicable for typical topical use. However, if significant systemic absorption occurs, interactions common to systemic sulfonamides may apply (e.g., methotrexate, phenytoin, warfarin, sulfonylureas).
Moderate Interactions
- Cimetidine (may increase risk of leukopenia)
- Phenytoin (may increase phenytoin levels if significant systemic absorption of sulfadiazine occurs)
- Warfarin (may potentiate anticoagulant effect if significant systemic absorption of sulfadiazine occurs)
- Sulfonylureas (may potentiate hypoglycemic effect if significant systemic absorption of sulfadiazine occurs)
Minor Interactions
- Not well-documented for topical use.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for leukopenia (especially neutropenia), which is a common adverse effect, particularly in the first few days of treatment.
Timing: Prior to initiation of therapy, especially for large surface area burns or prolonged use.
Renal function (BUN, creatinine)
Rationale: To establish baseline and monitor for potential renal impairment or crystalluria, especially with significant systemic absorption.
Timing: Prior to initiation of therapy, especially for large surface area burns or prolonged use.
Liver function tests (LFTs)
Rationale: To establish baseline and monitor for potential hepatic dysfunction, though less common.
Timing: Prior to initiation of therapy, especially for large surface area burns or prolonged use.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Every 2-3 days during initial treatment, then weekly if prolonged therapy, or as clinically indicated.
Target: WBC > 4,000 cells/mm³, Neutrophils > 1,500 cells/mm³
Action Threshold: Discontinue if WBC < 2,000 cells/mm³ or significant neutropenia develops; consider temporary discontinuation or alternative therapy.
Renal function (BUN, creatinine)
Frequency: Weekly or as clinically indicated, especially with large surface area burns or pre-existing renal impairment.
Target: Within normal limits for patient
Action Threshold: Significant increase in BUN/creatinine; consider discontinuation or dose adjustment if systemic absorption is suspected.
Urinalysis
Frequency: Periodically, especially with large surface area burns or pre-existing renal impairment.
Target: No crystalluria
Action Threshold: Presence of crystalluria; ensure adequate hydration.
Wound assessment
Frequency: Daily with dressing changes.
Target: Clean, granulating wound, absence of infection signs.
Action Threshold: Signs of infection (pus, increased pain, redness, fever), non-healing wound, or signs of local irritation/allergic reaction.
Symptom Monitoring
- Signs of infection (fever, chills, increased pain, redness, swelling, purulent drainage from wound)
- Signs of allergic reaction (rash, itching, hives, difficulty breathing, swelling of face/lips/tongue)
- Signs of systemic sulfonamide toxicity (nausea, vomiting, diarrhea, headache, dizziness, fatigue, skin rash, photosensitivity)
- Signs of blood dyscrasias (unusual bleeding/bruising, sore throat, fever, pallor, weakness)
- Signs of renal impairment (decreased urine output, swelling in ankles/feet)
- Signs of argyria (bluish-gray discoloration of skin, mucous membranes, or eyes - rare with topical use)
Special Patient Groups
Pregnancy
Category B for first and second trimesters (animal studies show no risk, but human data limited). Category D for third trimester (near term) due to risk of kernicterus in the neonate from systemic absorption of sulfadiazine, as sulfonamides can displace bilirubin from albumin. Avoid use in pregnant women at term or near term.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data; human data limited. Use only if clearly needed.
Second Trimester:
Low risk based on animal data; human data limited. Use only if clearly needed.
Third Trimester:
High risk (Category D). Contraindicated near term due to risk of kernicterus in the neonate.
Lactation
L3 (Moderate risk). Sulfonamides are excreted in breast milk and can cause kernicterus in jaundiced or premature infants, or infants with G6PD deficiency. Avoid use in breastfeeding mothers of premature infants, infants with hyperbilirubinemia, or infants with G6PD deficiency. For other infants, use with caution and monitor for adverse effects.
Infant Risk:
Risk of kernicterus, hemolytic anemia (in G6PD deficient infants), and allergic reactions. Consider alternative if possible.
Pediatric Use
Contraindicated in premature infants and neonates less than 2 months of age due to the risk of kernicterus. Use with caution in children, especially those with G6PD deficiency, due to the risk of hemolytic anemia. Monitor CBC closely. The safety and efficacy in pediatric patients older than 2 months have not been fully established, but it is widely used in this population for burn treatment.
Geriatric Use
No specific dose adjustments are typically needed. Use with caution in elderly patients who may have age-related decreases in renal or hepatic function, which could increase the risk of systemic accumulation if significant absorption occurs. Monitor for adverse effects, especially blood dyscrasias and renal function.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is a topical antimicrobial, not a systemic antibiotic. Its primary role is to prevent and treat wound infection in burns.
- Always apply to a clean, debrided wound surface.
- Maintain a continuous layer of cream over the burn wound at all times.
- Leukopenia (especially neutropenia) is the most common systemic adverse effect, usually transient and occurring within the first few days of treatment. Monitor CBCs.
- Avoid use in premature infants and neonates due to the risk of kernicterus.
- Avoid use in patients with G6PD deficiency due to the risk of hemolytic anemia.
- Patients with sulfa allergies should generally avoid this medication, though topical application may have a lower risk of systemic reaction compared to oral sulfonamides.
- Ensure adequate hydration to prevent crystalluria, especially with large surface area burns where systemic absorption is higher.
Alternative Therapies
- Mafenide acetate (Sulfamylon) cream/solution (another topical antimicrobial for burns, penetrates eschar better but can cause metabolic acidosis)
- Bacitracin/Polymyxin B topical ointment
- Povidone-iodine topical solution
- Topical antibiotics (e.g., mupirocin, neomycin/polymyxin B/bacitracin)
- Honey-based dressings (for some wound types)
- Advanced wound care dressings (e.g., silver-impregnated dressings, hydrogels, hydrocolloids)
Cost & Coverage
Average Cost:
$20 - $50 per 25gm tube of 1% cream
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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.