Silvadene 1% Cream 50gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical anti-infective; Burn agent
Pharmacologic Class
Sulfonamide; Silver salt
Pregnancy Category
Category B (avoid near term)
FDA Approved
Apr 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Silver sulfadiazine cream is a medicine applied to severe burns to prevent and treat infections. It contains a silver compound and an antibiotic (sulfadiazine) that work together to kill many types of bacteria.
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. Apply this medication only to your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if your hand is the area being treated, do not wash it after application. Wear protective gloves when applying the medication to prevent skin irritation.
Prepare the affected area by cleaning it and removing any dead skin. Then, apply a thin layer of the medication and gently rub it in. If necessary, cover the area with a dressing.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms and areas where children and pets can access it. Keep all medications in a safe and secure location. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal methods, which may include 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 scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Apply this medication only to your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if your hand is the area being treated, do not wash it after application. Wear protective gloves when applying the medication to prevent skin irritation.
Prepare the affected area by cleaning it and removing any dead skin. Then, apply a thin layer of the medication and gently rub it in. If necessary, cover the area with a dressing.
Storage and Disposal
Store this medication at room temperature in a dry place, avoiding bathrooms and areas where children and pets can access it. Keep all medications in a safe and secure location. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal methods, which may include 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 scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Wash your 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 (about 1/16 inch thick) of cream directly to the burn surface, ensuring the entire affected area is covered.
- The cream should be present on the wound at all times. Reapply if it rubs off or is removed during dressing changes.
- Dressings may or may not be used over the cream, as directed by your doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on the face unless specifically directed by a doctor, as it can cause temporary skin discoloration.
- Stay well-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 to affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm). The burn area should be covered with cream at all times.
Condition-Specific Dosing:
burns:
Apply to cleansed and debrided burn wounds.
Pediatric Dosing
Neonatal:
Contraindicated in premature infants and neonates (0-2 months) due to risk of kernicterus.
Infant:
Not established for infants 2 months to 2 years. Use with extreme caution and only if potential benefit outweighs risk.
Child:
Not established for children 2-12 years. Use with caution, monitoring for systemic absorption and adverse effects.
Adolescent:
Same as adult dosing, apply once or twice daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use due to minimal systemic absorption. Monitor for signs of systemic toxicity if large areas are treated.
Moderate:
No specific adjustment needed for topical use. Monitor for signs of systemic toxicity (e.g., leukopenia, crystalluria) if large areas are treated or prolonged use.
Severe:
No specific adjustment needed for topical use. Monitor closely for signs of systemic toxicity (e.g., leukopenia, crystalluria) due to potential for increased systemic exposure if significant absorption occurs.
Dialysis:
Considerations: Use with caution. Systemic absorption is minimal, but if significant, sulfadiazine is dialyzable. Monitor for systemic adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use. Monitor for signs of systemic toxicity if large areas are treated or prolonged use.
Severe:
No specific adjustment needed for topical use. Monitor closely for signs of systemic toxicity due to potential for altered metabolism if significant absorption occurs.
Pharmacology
Mechanism of Action
Silver sulfadiazine acts on the bacterial cell membrane and cell wall to produce its bactericidal effect. The silver ion is released slowly and acts on the bacterial cell wall and membrane, leading to structural damage and inhibition of DNA replication. The sulfadiazine component, a sulfonamide, interferes with bacterial folic acid synthesis by inhibiting dihydropteroate synthase, an enzyme essential for para-aminobenzoic acid (PABA) incorporation into folic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; approximately 1-10% of sulfadiazine and less than 1% of silver may be absorbed from the burn surface.
Tmax:
Not well-defined for topical application; systemic peak concentrations of sulfadiazine, if absorbed, typically occur within 3-11 hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application. If absorbed, sulfadiazine distributes widely into body tissues and fluids.
ProteinBinding:
If absorbed, sulfadiazine is approximately 50% protein bound.
CnssPenetration:
Limited (if absorbed, sulfadiazine can cross the blood-brain barrier, but systemic levels from topical application are usually too low to be clinically significant).
Elimination:
HalfLife:
If absorbed, sulfadiazine has a half-life of approximately 10 hours.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
If absorbed, sulfadiazine and its metabolites are primarily excreted renally.
Unchanged:
Approximately 60-80% of absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid antibacterial action upon application.
PeakEffect:
Sustained antibacterial activity as long as cream is present on the wound.
DurationOfAction:
Effective for 24 hours with once-daily application, or 12 hours with twice-daily application.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
+ Difficulty 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 extremely tired or weak
+ Bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Fatigue
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Changes in skin color
Skin irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
+ Difficulty 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 extremely tired or weak
+ Bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Fatigue
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Changes in skin color
Skin irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of worsening infection (e.g., increased pain, redness, swelling, pus, fever, chills)
- Severe skin rash, itching, or hives
- Unusual tiredness or weakness
- Sore throat or fever (could indicate a blood problem)
- Unusual bleeding or bruising
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Signs of kidney problems (e.g., decreased urination, swelling in ankles/feet)
- Bluish discoloration of skin or lips (rare, but could indicate methemoglobinemia)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the symptoms you experienced with the allergy.
A known sulfa allergy.
If you are pregnant, especially near term.
For 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 old.
Potential Interactions:
This medication may interact with other medications or health conditions. Therefore, it is crucial to discuss all your:
+ Prescription and over-the-counter (OTC) medications
+ Natural products
+ Vitamins
+ Health problems
with your doctor and pharmacist to ensure safe use.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so 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 with the allergy.
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 old.
Potential Interactions:
This medication may interact with other medications or health conditions. Therefore, it is crucial to discuss all your:
+ Prescription and over-the-counter (OTC) medications
+ Natural products
+ Vitamins
+ Health problems
with your doctor and pharmacist to ensure safe use.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so 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, 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 G6PD levels.
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 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 taking this medication to avoid any potential interactions.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of 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 G6PD levels.
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 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 taking this medication to avoid any potential interactions.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of systemic sulfonamide toxicity (e.g., nausea, vomiting, diarrhea, abdominal pain, dizziness, headache, confusion, fever, rash, blood dyscrasias like leukopenia, crystalluria, renal dysfunction)
- Symptoms of silver toxicity (argyria - bluish-gray skin discoloration, though rare with topical use)
What to Do:
If accidental ingestion or excessive topical absorption is suspected, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive and symptomatic, including hydration to prevent crystalluria, and monitoring of blood counts and renal function.
Drug Interactions
Major Interactions
- Proteolytic enzymes (e.g., collagenase, papain, sutilains): Silver can inactivate these enzymes, reducing their debriding action. Avoid concomitant use.
Moderate Interactions
- Cimetidine: Concomitant use with systemic sulfonamides has been reported to increase the risk of leukopenia. While systemic absorption of silver sulfadiazine is minimal, monitor blood counts if used concurrently, especially on large burn areas.
- Phenytoin: Sulfonamides can inhibit phenytoin metabolism, leading to increased phenytoin levels and toxicity. Monitor phenytoin levels if significant systemic absorption of 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/PT if significant systemic absorption occurs.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for leukopenia, a common adverse effect, especially transient leukopenia.
Timing: Prior to initiation of therapy, especially if large burn areas are treated.
Renal function (BUN, Creatinine)
Rationale: To establish baseline and monitor for potential renal impairment, particularly if significant systemic absorption occurs.
Timing: Prior to initiation of therapy, especially in patients with pre-existing renal impairment or large burn areas.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Every 2-3 days during initial treatment, then weekly or as clinically indicated.
Target: WBC: 4,500-11,000 cells/mm³
Action Threshold: If WBC count drops significantly (e.g., below 3,000 cells/mm³), consider temporary discontinuation or alternative therapy, and investigate other causes.
Renal function (BUN, Creatinine)
Frequency: Weekly or as clinically indicated, especially in patients with large burn areas or pre-existing renal impairment.
Target: BUN: 7-20 mg/dL; Creatinine: 0.6-1.2 mg/dL
Action Threshold: Significant increase in BUN/Creatinine may indicate renal impairment; consider hydration or dose adjustment if systemic absorption is suspected.
Urinalysis
Frequency: Periodically, especially if large areas are treated.
Target: Normal
Action Threshold: Presence of crystalluria may indicate need for increased hydration or discontinuation.
Wound appearance and healing progress
Frequency: Daily during dressing changes.
Target: Clean, granulating wound bed, reduction in exudate.
Action Threshold: Signs of worsening infection, delayed healing, or local irritation may require re-evaluation of therapy.
Symptom Monitoring
- Signs of infection (e.g., fever, increased pain, redness, swelling, purulent discharge from wound)
- Signs of systemic adverse effects (e.g., skin rash, itching, fever, sore throat, unusual bleeding or bruising, fatigue, jaundice)
- Signs of local irritation or allergic reaction (e.g., burning, stinging, itching, rash at application site)
- Signs of methemoglobinemia (rare, but possible with silver absorption: cyanosis, shortness of breath, fatigue)
Special Patient Groups
Pregnancy
Category B. While animal studies have not shown harm, adequate and well-controlled studies in pregnant women are lacking. Avoid use in pregnant women near term (third trimester) due to the risk of kernicterus in the neonate from systemic absorption of sulfadiazine.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data, but human data limited.
Second Trimester:
Low risk based on animal data, but human data limited.
Third Trimester:
Avoid use near term (especially last month of pregnancy) due to theoretical risk of kernicterus in the neonate if significant systemic absorption occurs.
Lactation
L4 (Potentially Hazardous). Sulfonamides are excreted in breast milk. Contraindicated in nursing mothers of premature infants, infants with hyperbilirubinemia, or infants with G6PD deficiency due to the risk of kernicterus.
Infant Risk:
Risk of kernicterus (brain damage due to high bilirubin) in susceptible infants (premature, jaundiced, G6PD deficient). Otherwise, risk is generally low for healthy, full-term infants, but caution is advised.
Pediatric Use
Contraindicated in premature infants and neonates (0-2 months) due to the risk of kernicterus. Use with extreme caution in infants and young children due to the potential for increased systemic absorption and higher risk of adverse effects compared to adults. Monitor closely for systemic effects (e.g., leukopenia, rash).
Geriatric Use
Generally safe for use in geriatric patients. However, monitor renal function, especially if large areas are treated, as age-related decline in renal function may increase systemic exposure if absorption occurs. Monitor for blood dyscrasias.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is a broad-spectrum antimicrobial effective against many bacteria and some fungi commonly found in burn wounds.
- It is generally well-tolerated, but transient leukopenia (low white blood cell count) is a common, usually self-limiting, side effect.
- Ensure the burn wound is continuously covered with the cream for optimal efficacy.
- Avoid using on the face unless specifically instructed, as it can cause temporary skin discoloration (argyria) with prolonged use.
- Not indicated for routine use on minor burns or abrasions where infection risk is low.
- Patients should be well-hydrated to minimize the risk of crystalluria if systemic absorption occurs.
Alternative Therapies
- Mafenide acetate (Sulfamylon) cream/solution (another topical sulfonamide for burns)
- Bacitracin/Polymyxin B topical ointment
- Povidone-iodine topical solution
- Honey-based wound dressings
- Topical antiseptics (e.g., chlorhexidine)
- Advanced wound care dressings (e.g., hydrocolloids, alginates, hydrogels)
Cost & Coverage
Average Cost:
$20 - $50 per 50gm 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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.