Silvadene 1% Cream 85gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Anti-infective, Topical
Pharmacologic Class
Sulfonamide, Silver Salt
Pregnancy Category
Category B (Category D if used near term)
FDA Approved
Apr 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Silver sulfadiazine is a cream used to prevent and treat wound infections, especially in people with severe burns. It contains a silver compound and an antibiotic that work together to kill bacteria and help the 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
Do not take this medication by mouth. It is for topical use on your skin only.
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 the medication at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on disposal or check for 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 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
Do not take this medication by mouth. It is for topical use on your skin only.
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 the medication at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on disposal or check for 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.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the cream.
- Clean the 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 wound surface.
- Keep the wound covered with the cream at all times. If the cream is rubbed off or removed (e.g., during bathing), reapply it immediately.
- Wear sterile gloves if possible when applying the cream to avoid contamination.
- Do not use on the eyes.
- Avoid contact with clothing as it may stain.
Available Forms & Alternatives
Available Strengths:
Generic 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 cleansed and debrided burn wounds once or twice daily. Reapply if removed by patient activity or hydrotherapy.
Pediatric Dosing
Neonatal:
Not established (Contraindicated in premature and full-term neonates due to risk of kernicterus).
Infant:
Not established (Use with caution in infants less than 2 months of age due to risk of kernicterus).
Child:
Apply to a thickness of approximately 1/16 inch (1.5 mm) once or twice daily.
Adolescent:
Apply to a thickness of approximately 1/16 inch (1.5 mm) once or twice daily.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution, especially if applied to large body surface areas or for prolonged periods, due to potential for systemic absorption.
Moderate:
Use with caution, especially if applied to large body surface areas or for prolonged periods, due to potential for systemic absorption. Monitor renal function and CBC.
Severe:
Use with caution, especially if applied to large body surface areas or for prolonged periods, due to potential for systemic absorption. Monitor renal function and CBC.
Dialysis:
Considered safe for topical use, but monitor for systemic effects if significant absorption occurs.
Hepatic Impairment:
Mild:
Use with caution, especially if applied to large body surface areas or for prolonged periods, due to potential for systemic absorption.
Moderate:
Use with caution, especially if applied to large body surface areas or for prolonged periods, due to potential for systemic absorption. Monitor hepatic function and CBC.
Severe:
Use with caution, especially if applied to large body surface areas or for prolonged periods, due to potential for systemic absorption. Monitor hepatic function and CBC.
Pharmacology
Mechanism of Action
Silver sulfadiazine dissociates into silver ions and sulfadiazine. The silver ions exert bactericidal effects by binding to bacterial DNA and cell walls, disrupting cell membrane integrity and inhibiting bacterial growth. The sulfadiazine component also contributes bacteriostatic activity by inhibiting bacterial folic acid synthesis, a mechanism common to sulfonamides.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1-10% of sulfadiazine, negligible silver) from intact skin; absorption increases with larger burn areas and deeper burns.
Tmax:
Not well-defined for topical application; systemic peak concentrations of sulfadiazine are generally low and variable.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical formulation; for absorbed sulfadiazine, it distributes widely.
ProteinBinding:
Sulfadiazine component is approximately 85-90% protein bound in plasma.
CnssPenetration:
Limited for topical application; for absorbed sulfadiazine, it can penetrate the CNS.
Elimination:
HalfLife:
Not well-defined for topical application; for absorbed sulfadiazine, it is approximately 10 hours.
Clearance:
Not well-defined for topical application; for absorbed sulfadiazine, primarily renal.
ExcretionRoute:
Primarily renal excretion for absorbed sulfadiazine and its metabolites.
Unchanged:
Approximately 30-50% of absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid local antimicrobial effect upon application.
PeakEffect:
Not precisely quantifiable for topical antimicrobial action.
DurationOfAction:
Continuous antimicrobial activity as long as the cream remains 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 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 very tired or weak
+ Bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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 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 very tired or weak
+ Bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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:
- Signs of allergic reaction: severe rash, hives, itching, swelling of face/lips/tongue, difficulty breathing.
- Signs of systemic absorption/toxicity: fever, chills, sore throat, unusual bleeding or bruising, yellowing of skin or eyes (jaundice), dark urine, severe fatigue.
- Signs of worsening infection: increased pain, redness, swelling, pus, foul odor from the wound.
- Skin discoloration (argyria) - rare with topical use but possible with prolonged, extensive use.
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 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. Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to ensure it is safe to take this medication.
Do not start, stop, or change the dose of any medication without consulting your doctor first. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 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. Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to ensure it is safe to take this medication.
Do not start, stop, or change the dose of any medication without consulting your doctor first. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 sunlight, making you more prone to sunburn. Take necessary precautions when exposed to the sun, 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 case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
As this medication may interfere with certain laboratory tests, ensure that your doctor and laboratory personnel are aware that you are taking 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 sunlight, making you more prone to sunburn. Take necessary precautions when exposed to the sun, 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 case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
As this medication may interfere with certain laboratory tests, ensure that your doctor and laboratory personnel are aware that you are taking 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:
- Symptoms of systemic sulfonamide toxicity: nausea, vomiting, diarrhea, abdominal pain, dizziness, headache, crystalluria (blood in urine, painful urination), bone marrow suppression (fatigue, fever, sore throat, easy bruising/bleeding).
What to Do:
If swallowed or if significant systemic absorption is suspected, seek immediate medical attention. Call a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Contraindicated Interactions
- Enzymatic debriding agents (e.g., collagenase, papain, sutilains) - Silver can inactivate these enzymes.
Moderate Interactions
- Cimetidine - Concurrent use has been associated with an increased incidence of leukopenia.
- Systemic sulfonamides - Although systemic absorption is minimal, theoretical additive effects (e.g., bone marrow suppression, crystalluria) could occur if significant absorption happens, especially in patients with pre-existing conditions.
Confidence Interactions
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline values, especially if large body surface areas are treated or prolonged therapy is anticipated, due to potential for leukopenia, agranulocytosis, or aplastic anemia.
Timing: Prior to initiation of therapy, particularly for extensive burns.
Renal and Hepatic Function Tests (BUN, creatinine, LFTs)
Rationale: To assess baseline organ function, as absorbed sulfadiazine is metabolized by the liver and excreted by the kidneys. Important for patients with pre-existing impairment.
Timing: Prior to initiation of therapy, particularly for extensive burns or prolonged use.
Routine Monitoring
Wound appearance and signs of infection
Frequency: Daily
Target: Clean, granulating wound; absence of purulence, erythema, or increasing pain.
Action Threshold: Worsening infection, non-healing wound, 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/mm³), neutrophil count within normal limits.
Action Threshold: Significant drop in WBC count (<3,000/mm³), particularly neutropenia (<1,000/mm³), requiring consideration of drug discontinuation or dose adjustment.
Renal and Hepatic Function Tests
Frequency: Periodically, especially with prolonged use or large surface area application.
Target: Within normal limits.
Action Threshold: Significant elevation in BUN, creatinine, or LFTs, indicating potential systemic toxicity.
Symptom Monitoring
- Skin rash (maculopapular, urticarial, or exfoliative dermatitis)
- Pruritus
- Burning sensation at application site
- Fever
- Chills
- Sore throat (may indicate blood dyscrasias)
- Unusual bleeding or bruising
- Fatigue or weakness (may indicate anemia)
- Nausea, vomiting, diarrhea
- Signs of crystalluria (e.g., flank pain, hematuria) - rare with topical use but possible with significant absorption
- Signs of methemoglobinemia (cyanosis, shortness of breath) - rare
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, as sulfonamides can displace bilirubin from albumin binding sites.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk, but use only if clearly needed.
Second Trimester:
Generally considered low risk, but use only if clearly needed.
Third Trimester:
Contraindicated due to risk of kernicterus in the neonate.
Lactation
Contraindicated. Sulfonamides are excreted in breast milk and can cause kernicterus in infants, especially those with hyperbilirubinemia or G6PD deficiency. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
High risk (L5) due to potential for kernicterus, hemolytic anemia (in G6PD deficient infants), and other sulfonamide-related adverse effects.
Pediatric Use
Contraindicated in premature and full-term neonates (infants less than 2 months of age) due to the risk of kernicterus. Use with caution in older infants and children, especially if applied to large areas, due to potential for systemic absorption and sulfonamide-related adverse effects.
Geriatric Use
No specific dose adjustments are typically required. However, elderly patients may have decreased renal or hepatic function, which could increase the risk of systemic adverse effects if significant absorption occurs. Monitor for signs of systemic toxicity and blood dyscrasias.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is for external use only. Do not ingest or apply to the eyes.
- The cream should be applied to a clean, debrided wound surface. Reapply if the cream is removed by patient activity or hydrotherapy.
- Monitor for signs of systemic absorption, especially in patients with extensive burns, as this can lead to sulfonamide-related adverse effects (e.g., leukopenia, crystalluria).
- Patients with a known sulfa allergy should generally avoid this medication. However, topical application may have a lower risk of systemic reaction compared to oral sulfonamides.
- Discontinue use if signs of hypersensitivity or adverse reactions occur.
- The silver component can cause a temporary, reversible discoloration of the skin (argyria) with prolonged use, though this is rare with typical topical application.
Alternative Therapies
- Mafenide acetate (Sulfamylon) - another topical antimicrobial for burns, penetrates eschar better but can cause metabolic acidosis.
- Topical antibiotics (e.g., bacitracin, polymyxin B, neomycin) - for less severe or superficial infections.
- Honey-based dressings - for wound healing and antimicrobial properties.
- Povidone-iodine - broad-spectrum antiseptic, but can be cytotoxic to healing tissue and systemically absorbed.
Cost & Coverage
Average Cost:
$20 - $50 per 85gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check 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.