Silvadene 1% Cream 20gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical Anti-infective
Pharmacologic Class
Sulfonamide Antimicrobial; Topical Burn Agent
Pregnancy Category
Category B (first and second trimesters), Category D (third trimester and near term)
FDA Approved
Apr 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Silver sulfadiazine cream is a medicine applied to burns to help prevent and treat infections. It contains a silver compound and an antibiotic that work together to kill bacteria and promote healing.
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 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. 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 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
- Wash your hands before and after applying the cream.
- Clean and debride the burn wound as directed by your healthcare provider before applying the cream.
- Apply a thin layer of cream (about 1/16 inch thick) directly to the burn wound. The cream should cover the entire affected area.
- Keep the treated area covered with the cream at all times. If the cream rubs off, reapply it.
- Dressings may or may not be used, as directed by your doctor.
- Avoid getting the cream in your eyes.
- Do not use on your face unless specifically instructed by your doctor, as it can cause temporary skin discoloration.
- Stay hydrated to help prevent kidney problems, especially if treating large areas.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer (approximately 1/16 inch or 1.5 mm thick) to the affected area once or twice daily.
Condition-Specific Dosing:
burns:
Apply to cleansed and debrided burn wounds. Reapply if removed by patient activity or hydrotherapy. Continue until healing is complete or the burn site is ready for grafting.
Pediatric Dosing
Neonatal:
Contraindicated in premature infants and neonates less than 2 months of age due to the 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 a thin layer once or twice daily to cleansed and debrided burn wounds. Use with caution, especially on large surface areas, due to potential for systemic absorption.
Adolescent:
Apply a thin layer once or twice daily to cleansed and debrided burn wounds.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for topical use, but monitor for signs of systemic absorption if applied to large areas or for prolonged periods.
Moderate:
No specific adjustment for topical use, but monitor for signs of systemic absorption if applied to large areas or for prolonged periods. Consider reduced frequency if significant systemic absorption occurs.
Severe:
No specific adjustment for topical use, but monitor for signs of systemic absorption if applied to large areas or for prolonged periods. Avoid use on large areas or for prolonged periods if possible.
Dialysis:
Not well studied for topical use. If significant systemic absorption occurs, sulfadiazine is dialyzable. Use with caution and monitor for systemic effects.
Hepatic Impairment:
Mild:
No specific adjustment for topical use, but monitor for signs of systemic absorption if applied to large areas or for prolonged periods.
Moderate:
No specific adjustment for topical use, but monitor for signs of systemic absorption if applied to large areas or for prolonged periods. Use with caution.
Severe:
No specific adjustment for topical use, but monitor for signs of systemic absorption if applied to large areas or for prolonged periods. Avoid use on large areas or for prolonged periods if possible.
Pharmacology
Mechanism of Action
Silver sulfadiazine exerts its bactericidal action through the slow release of silver ions and sulfadiazine. The silver ions act on the bacterial cell wall and membrane, causing structural damage and inhibiting DNA replication. The sulfadiazine component interferes with bacterial folic acid synthesis by competing with para-aminobenzoic acid (PABA), an essential component for bacterial growth, leading to bacteriostasis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; however, significant absorption of both silver and sulfadiazine can occur, especially when applied to large areas of deep burns or denuded skin. Up to 10% of the sulfadiazine and 1% of the silver may be absorbed.
Tmax:
Not well-defined for topical application; systemic peak concentrations, if absorbed, would vary.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application. If absorbed, sulfadiazine distributes widely into body tissues and fluids.
ProteinBinding:
Sulfadiazine: Approximately 50% (if absorbed systemically).
CnssPenetration:
Limited (if absorbed systemically, sulfadiazine can penetrate the CNS to some extent, especially in the presence of inflamed meninges).
Elimination:
HalfLife:
Sulfadiazine: Approximately 10 hours (if absorbed systemically).
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Renal (primarily for absorbed sulfadiazine and silver).
Unchanged:
Approximately 30-60% of absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Immediate (topical antimicrobial action).
PeakEffect:
Not applicable for topical action; sustained release of active components.
DurationOfAction:
Continuous as long as the cream is on the wound surface, typically applied once or twice daily.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when 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
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 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 experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Changes in skin color
Skin irritation
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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
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 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 experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Changes in skin color
Skin irritation
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns 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 worsening infection (increased redness, swelling, pain, pus, fever)
- Severe skin rash, blistering, or peeling (could be a sign of a serious allergic reaction like Stevens-Johnson syndrome)
- Unusual tiredness or weakness
- Sore throat or fever (could be signs of blood problems)
- Easy bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Bluish discoloration of the skin or mucous membranes (argyria)
- Nausea, vomiting, or diarrhea that is severe or persistent
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 allergic reactions you have experienced.
A known sulfa allergy.
If you are pregnant, particularly if you are near term.
For Parents or Caregivers:
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.
Potential Interactions:
This medication may interact with other medications or health conditions. Therefore, it is crucial to discuss all of the following with your doctor and pharmacist:
+ All prescription and over-the-counter medications you are taking.
+ Any natural products or vitamins you are using.
+ Existing health problems.
* Ensure that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first 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 allergic reactions you have experienced.
A known sulfa allergy.
If you are pregnant, particularly if you are near term.
For Parents or Caregivers:
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.
Potential Interactions:
This medication may interact with other medications or health conditions. Therefore, it is crucial to discuss all of the following with your doctor and pharmacist:
+ All prescription and over-the-counter medications you are taking.
+ Any natural products or vitamins you are using.
+ Existing health problems.
* Ensure that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first 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 an extended period beyond the recommended duration, 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 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 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 an extended period beyond the recommended duration, 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 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 this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- If a large amount is accidentally ingested or absorbed systemically (e.g., from very large burn areas), symptoms could include nausea, vomiting, diarrhea, headache, dizziness, blood disorders (e.g., leukopenia, agranulocytosis), kidney problems (e.g., crystalluria, renal failure), liver problems, and skin reactions (e.g., rash, Stevens-Johnson syndrome).
- Long-term excessive use, especially on large areas, can lead to argyria (bluish-gray skin discoloration due to silver accumulation).
What to Do:
If overdose is suspected or a large amount is ingested, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive and symptomatic. Hemodialysis may be considered for severe systemic toxicity from sulfadiazine absorption.
Drug Interactions
Major Interactions
- Enzymatic debriding agents (e.g., collagenase, papain, sutilains): Silver can inactivate these enzymes. Avoid concurrent use.
Moderate Interactions
- Cimetidine: Concurrent use with systemic sulfonamides has been reported to increase the incidence of leukopenia. While systemic absorption from topical silver sulfadiazine is usually low, caution is advised.
- Phenytoin: Sulfonamides can inhibit phenytoin metabolism, leading to increased phenytoin levels and toxicity. Monitor phenytoin levels if significant systemic absorption of silver sulfadiazine occurs.
- Oral hypoglycemics (sulfonylureas): Sulfonamides can potentiate the hypoglycemic effect. Monitor blood glucose if significant systemic absorption occurs.
- Warfarin: Sulfonamides can potentiate the anticoagulant effect. Monitor INR if significant systemic absorption occurs.
- Methotrexate: Sulfonamides can displace methotrexate from protein binding sites and inhibit renal excretion, increasing methotrexate toxicity. Avoid concurrent use if possible, especially with large surface area application.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters, as sulfonamides can cause leukopenia, agranulocytosis, aplastic anemia, and thrombocytopenia, especially with systemic absorption.
Timing: Prior to initiation of therapy, especially if large surface areas are treated.
Renal function (BUN, creatinine)
Rationale: To assess baseline kidney function, as sulfadiazine is renally excreted and can cause crystalluria or renal impairment.
Timing: Prior to initiation of therapy, especially if large surface areas are treated or in patients with pre-existing renal impairment.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline liver function, as sulfonamides can cause hepatic dysfunction.
Timing: Prior to initiation of therapy, especially if large surface areas are treated or in patients with pre-existing hepatic impairment.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: At least twice weekly, especially if applied to large areas or for prolonged periods.
Target: Within normal limits for age and patient.
Action Threshold: Discontinue if leukopenia (neutrophil count <1000/mm³) or other significant hematologic abnormalities occur.
Renal function (BUN, creatinine)
Frequency: Periodically, especially if applied to large areas or for prolonged periods.
Target: Within normal limits.
Action Threshold: Significant increase in BUN/creatinine; consider discontinuation or dose adjustment if systemic absorption is suspected.
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically, especially if applied to large areas or for prolonged periods.
Target: Within normal limits.
Action Threshold: Significant elevation; consider discontinuation.
Wound assessment (signs of infection, healing progress)
Frequency: Daily or with each dressing change.
Target: Reduction in signs of infection, progression of wound healing.
Action Threshold: Worsening infection, non-healing wound, signs of systemic infection.
Skin assessment (for rash, allergic reactions, argyria)
Frequency: Daily.
Target: Absence of adverse skin reactions.
Action Threshold: Development of rash, itching, erythema, or bluish discoloration of skin/mucous membranes (argyria).
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Unusual bleeding or bruising
- Fatigue
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe skin rash (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Nausea
- Vomiting
- Diarrhea
- Headache
- Dizziness
- Bluish discoloration of skin or mucous membranes (argyria)
Special Patient Groups
Pregnancy
Category B for first and second trimesters; Category D for third trimester and near term. Avoid use in the third trimester or near term due to the risk of kernicterus in the neonate (displacement of bilirubin from albumin binding sites). Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Category B. No evidence of harm in animal studies, but human data are limited. Use only if clearly needed.
Second Trimester:
Category B. No evidence of harm in animal studies, but human data are limited. Use only if clearly needed.
Third Trimester:
Category D. Contraindicated in the third trimester and near term due to the risk of kernicterus in the neonate (sulfonamides can displace bilirubin from albumin binding sites).
Lactation
L3 (Moderately Safe). Sulfonamides are excreted in breast milk. Caution is advised. Avoid use in nursing mothers if the infant is premature, has hyperbilirubinemia, or has G6PD deficiency, due to the risk of kernicterus or hemolytic anemia in the infant.
Infant Risk:
Risk of kernicterus (especially in premature or jaundiced infants) or hemolytic anemia (in G6PD deficient infants). Monitor infant for jaundice, lethargy, or signs of hemolytic anemia.
Pediatric Use
Contraindicated in premature infants and neonates less than 2 months of age due to the risk of kernicterus. Use with extreme caution in children, especially on large surface areas, due to potential for systemic absorption and associated risks (e.g., blood dyscrasias, kernicterus).
Geriatric Use
No specific dose adjustments are generally needed. However, geriatric patients may be more susceptible to adverse effects due to age-related decreases in renal function or concurrent medical conditions. Monitor closely for systemic adverse effects, especially if applied to large areas.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is for external use only. Do not ingest.
- Always clean and debride the burn wound thoroughly before applying the cream.
- Maintain a continuous layer of cream over the wound at all times. Reapply if removed by activity or hydrotherapy.
- Monitor CBC, renal, and liver function, especially with large surface area burns, due to potential for systemic absorption.
- Be aware of the risk of kernicterus in neonates and infants <2 months; it is contraindicated in this age group.
- Avoid concurrent use with enzymatic debriding agents, as silver can inactivate them.
- Protect treated areas from direct sunlight, as sulfonamides can cause photosensitivity.
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 dressings (medical grade)
- Advanced wound care dressings (e.g., hydrocolloids, hydrogels, alginates, silver-impregnated dressings)
Cost & Coverage
Average Cost:
$15 - $40 per 20gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.