Silvadene 1% Cream 400gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical anti-infective
Pharmacologic Class
Sulfonamide derivative; Topical antimicrobial
Pregnancy Category
Category B (Category D in late pregnancy)
FDA Approved
Apr 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 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 on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using this medication as instructed, even if your symptoms improve. 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 skin irritation.
To apply, first clean the affected area and remove any dead skin. Then, gently rub a thin layer of the medication onto the affected area. If necessary, cover the 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 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 about disposal, 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. However, 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 make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using this medication as instructed, even if your symptoms improve. 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 skin irritation.
To apply, first clean the affected area and remove any dead skin. Then, gently rub a thin layer of the medication onto the affected area. If necessary, cover the 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 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 about disposal, 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. However, 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 make up for a missed one.
Lifestyle & Tips
- Keep the burn wound clean as instructed by your healthcare provider.
- Apply the cream exactly as directed, usually once or twice a day.
- Keep the treated area covered with a dressing if advised by your doctor.
- Wash your hands thoroughly before and after applying the cream.
- Avoid getting the cream in your eyes or mouth.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area 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 or hydrotherapy.
Pediatric Dosing
Neonatal:
Not established (Contraindicated in premature and newborn infants due to risk of kernicterus).
Infant:
Not established (Contraindicated in infants < 2 months due to risk of kernicterus).
Child:
Apply once or twice daily to a thickness of approximately 1/16 inch (1.5 mm) to cleansed and debrided burn wounds. Use with caution, especially in children with G6PD deficiency.
Adolescent:
Apply once or twice daily to a thickness of approximately 1/16 inch (1.5 mm) to cleansed and debrided burn wounds.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment recommended for topical use due to minimal systemic absorption. Monitor for signs of systemic absorption if applied to large areas or severe burns.
Severe:
No specific adjustment recommended for topical use due to minimal systemic absorption. Monitor for signs of systemic absorption if applied to large areas or severe burns.
Dialysis:
No specific adjustment recommended for topical use due to minimal systemic absorption. Monitor for signs of systemic absorption if applied to large areas or severe burns.
Hepatic Impairment:
Mild:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment recommended for topical use due to minimal systemic absorption. Monitor for signs of systemic absorption if applied to large areas or severe burns.
Severe:
No specific adjustment recommended for topical use due to minimal systemic absorption. Monitor for signs of systemic absorption if applied to large areas or severe burns.
Pharmacology
Mechanism of Action
Silver sulfadiazine dissociates into silver ions and sulfadiazine. The silver ion acts on the bacterial cell wall and membrane, disrupting their integrity and inhibiting DNA replication. The sulfadiazine component inhibits bacterial folic acid synthesis, a mechanism common to sulfonamides. 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 1-10% of sulfadiazine and trace amounts of silver). Absorption may be increased with extensive burns or prolonged use.
Tmax:
Not applicable for topical application; systemic peak concentrations of sulfadiazine, if absorbed, are typically low and variable.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-quantified for topical application; primarily local action.
ProteinBinding:
Sulfadiazine, if absorbed, is approximately 85-90% protein bound.
CnssPenetration:
Limited (for systemically absorbed components).
Elimination:
HalfLife:
Approximately 10 hours (for systemically absorbed sulfadiazine).
Clearance:
Not well-quantified for topical application.
ExcretionRoute:
Systemically absorbed sulfadiazine and its metabolites are primarily excreted renally.
Unchanged:
Approximately 50-60% of absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid (antimicrobial effect begins upon contact with the wound).
PeakEffect:
Not applicable for topical antimicrobial effect; continuous activity as long as present on wound.
DurationOfAction:
Maintained as long as the cream is present on the wound surface, 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
Urination problems, such as:
+ Inability to pass urine
+ Changes in the amount of urine passed
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 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. 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:
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. 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, such as:
+ Inability to pass urine
+ Changes in the amount of urine passed
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 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. 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:
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. 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:
- New or worsening redness, swelling, pain, or pus around the burn (signs of infection)
- Fever or chills
- Skin rash, itching, or hives (signs of allergic reaction)
- Unusual tiredness or weakness, easy bruising or bleeding (possible blood problems)
- Bluish discoloration of skin or lips (rare, but seek immediate medical attention)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
A known sulfa allergy.
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 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. Be sure to describe the symptoms you experienced.
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 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 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 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 using this drug.
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 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 using this drug.
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:
- While systemic overdose from topical application is rare due to minimal absorption, symptoms could include:
- Nausea, vomiting
- Diarrhea
- Headache
- Dizziness
- Fever
- Skin rash
- Blood disorders (e.g., leukopenia, thrombocytopenia, hemolytic anemia - rare)
- Renal dysfunction (rare)
What to Do:
If you suspect an overdose or severe reaction, stop using the cream and call your doctor or poison control center immediately. In the US, call 1-800-222-1222. Treatment is supportive and symptomatic.
Drug Interactions
Major Interactions
- Enzymatic debriding agents (e.g., collagenase, sutilains): Silver can inactivate these enzymes. Avoid concomitant use.
Moderate Interactions
- Cimetidine: Concomitant use has been associated with an increased incidence of leukopenia.
- Phenytoin: Sulfonamides can inhibit phenytoin metabolism, potentially increasing phenytoin levels and toxicity.
Monitoring
Baseline Monitoring
Wound assessment (size, depth, infection signs)
Rationale: To establish baseline for treatment efficacy and identify potential complications.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To establish baseline, as leukopenia (transient) can occur, especially with extensive burns.
Timing: Prior to initiation of therapy.
Routine Monitoring
Wound healing progress
Frequency: Daily or at 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 infection (redness, swelling, pain, purulent discharge)
Frequency: Daily or at each dressing change
Target: Absence of signs of infection
Action Threshold: Presence or worsening of infection signs
Complete Blood Count (CBC) with differential (especially WBC count)
Frequency: Twice weekly (especially during the first few days of therapy or with extensive burns)
Target: Normal range for age
Action Threshold: Significant drop in WBC count (leukopenia), particularly granulocytes
Renal function (BUN, creatinine)
Frequency: Periodically, especially with extensive burns or pre-existing renal impairment
Target: Normal range for age
Action Threshold: Significant increase in BUN/creatinine
Symptom Monitoring
- Skin rash or itching (signs of allergic reaction)
- Fever, chills, malaise (signs of systemic infection or drug reaction)
- Nausea, vomiting, diarrhea (rare, but possible systemic effects)
- Signs of methemoglobinemia (cyanosis, shortness of breath) - very rare
- Signs of argyria (bluish discoloration of skin/mucous membranes) - rare, with prolonged/extensive use
Special Patient Groups
Pregnancy
Category B. However, it is contraindicated in pregnant women nearing term (third trimester) due to the risk of kernicterus in the newborn from sulfonamide displacement of bilirubin. Use during pregnancy should only be if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk (Category B).
Second Trimester:
Generally considered low risk (Category B).
Third Trimester:
Category D. Contraindicated due to risk of kernicterus in the newborn if used near term.
Lactation
L3 (Moderately safe). Caution is advised. Sulfonamides are excreted in breast milk and can cause kernicterus in jaundiced, premature, or G6PD-deficient infants. Avoid use in these high-risk infants. For healthy, full-term infants, monitor for signs of jaundice or adverse effects.
Infant Risk:
Risk of kernicterus in premature, jaundiced, or G6PD-deficient infants. Low risk for healthy, full-term infants, but monitor.
Pediatric Use
Contraindicated in premature and newborn infants (up to 2 months of age) due to the risk of kernicterus. Use with caution in older children, especially those with G6PD deficiency, due to the risk of hemolytic anemia. Safety and efficacy in children under 2 months have not been established.
Geriatric Use
No specific dosage adjustments are generally required. However, elderly patients may have reduced renal function, which could theoretically increase systemic exposure if significant absorption occurs. Monitor for adverse effects, particularly blood dyscrasias.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is a cornerstone in burn wound management due to its broad-spectrum antimicrobial activity and ease of application.
- Always cleanse and debride the wound thoroughly before applying the cream.
- A thin layer (1/16 inch) is usually sufficient; excessive application does not enhance efficacy.
- Monitor CBC, especially WBC count, as transient leukopenia is a known, though usually self-limiting, side effect.
- Be aware of potential drug interactions, particularly with enzymatic debriding agents (inactivation) and cimetidine (increased leukopenia risk).
- Contraindicated in neonates and premature infants due to the risk of kernicterus.
- Patients with G6PD deficiency are at increased risk of hemolytic anemia.
- The cream should be reapplied if it is washed off during hydrotherapy or patient activity.
Alternative Therapies
- Mafenide acetate cream (Sulfamylon)
- Topical antibiotics (e.g., bacitracin, polymyxin B, neomycin for minor burns)
- Antiseptics (e.g., povidone-iodine, chlorhexidine - generally not preferred for deep burns)
- Honey-based dressings (for some burn types)
- Biologic dressings (e.g., allograft, xenograft)
- Synthetic dressings
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200+ per 400gm tube
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'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 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 overdose, including the medication taken, the amount, and the time it occurred.