Silver Sulfadiazine 1% Cream 400gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical Anti-infective
Pharmacologic Class
Sulfonamide Antibiotic; Silver Salt
Pregnancy Category
Category B
FDA Approved
Apr 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Silver sulfadiazine cream is a topical medication used to prevent and treat infections in severe burns. It contains an antibiotic (sulfadiazine) and silver, which work together to kill a wide range of bacteria and some fungi that can infect burn wounds.
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 skin irritation.
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 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. 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 skin irritation.
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 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
- Keep the treated area clean and covered with the cream as directed.
- Wash hands thoroughly before and after applying the cream.
- 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 may cause temporary skin discoloration.
- Avoid exposure to direct sunlight or tanning beds while using this medication, as it may increase sensitivity to light (photosensitivity).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply 1% cream to the affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm).
Condition-Specific Dosing:
burns:
Apply to cleansed and debrided burn wounds once or twice daily. Reapply immediately if removed by patient activity.
Pediatric Dosing
Neonatal:
Contraindicated in premature infants and infants <2 months of age due to risk of kernicterus.
Infant:
Contraindicated in infants <2 months of age. For infants >2 months, use with caution and only if benefits outweigh risks. Dosing similar to adult, but monitor closely for systemic absorption.
Child:
Apply 1% cream to the affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm). Monitor for systemic absorption, especially in large burn areas.
Adolescent:
Apply 1% cream to the affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical use, but monitor for signs of systemic absorption if large areas are treated.
Moderate:
No specific adjustment recommended for topical use, but monitor for signs of systemic absorption if large areas are treated.
Severe:
Use with caution; monitor for signs of systemic absorption (e.g., crystalluria, renal toxicity) if large areas are treated, as sulfonamide excretion may be impaired. Consider alternative if significant absorption is anticipated.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific adjustment recommended for topical use.
Moderate:
No specific adjustment recommended for topical use.
Severe:
Use with caution; monitor for signs of systemic absorption if large areas are treated, as sulfonamide metabolism may be impaired. Consider alternative if significant absorption is anticipated.
Confidence:
Medium
Pharmacology
Mechanism of Action
Silver sulfadiazine acts on the bacterial cell wall and cell membrane to produce its bactericidal effect. The silver component is thought to bind to bacterial DNA, inhibiting DNA replication and cell division. The sulfadiazine component, a sulfonamide, interferes with bacterial folic acid synthesis by competing with para-aminobenzoic acid (PABA), an essential component for bacterial growth. This dual mechanism provides broad-spectrum antimicrobial activity against many Gram-positive and Gram-negative bacteria, as well as some yeasts.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1% of silver and 10% of sulfadiazine) from intact skin; absorption increases with larger burn areas or damaged skin.
Tmax:
Not available (systemic absorption is minimal and variable)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not available (systemic absorption is minimal)
ProteinBinding:
Sulfadiazine: Approximately 85-90% (if systemically absorbed)
CnssPenetration:
Limited (if systemically absorbed)
Elimination:
HalfLife:
Sulfadiazine: 10 hours (if systemically absorbed)
Clearance:
Not available (systemic absorption is minimal)
ExcretionRoute:
Renal (primarily for sulfadiazine, if systemically absorbed); silver is excreted in feces and urine.
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Rapid (local antimicrobial effect)
PeakEffect:
Not applicable (local action)
DurationOfAction:
Approximately 24 hours (due to once or 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Urination problems, including inability to pass urine or changes in urine output
Severe effects associated with sulfa drugs, which can be life-threatening, 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:
Skin color changes
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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Urination problems, including inability to pass urine or changes in urine output
Severe effects associated with sulfa drugs, which can be life-threatening, 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:
Skin color changes
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 allergic reaction: severe rash, itching, hives, swelling of the face/lips/tongue/throat, difficulty breathing.
- Signs of worsening infection: increased redness, swelling, pain, pus, or fever.
- Signs of blood problems: unusual bleeding or bruising, sore throat, fever, extreme tiredness.
- Signs of kidney problems: decreased urination, swelling in the legs or feet.
- Signs of liver problems: yellowing of the skin or eyes (jaundice), dark urine, severe stomach pain.
- Skin discoloration (bluish-gray) at the application site (argyria), though rare with topical 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 with the allergy.
A known sulfa allergy.
If you are pregnant, especially near term.
For Parents and 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 dosage 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 with the allergy.
A known sulfa allergy.
If you are pregnant, especially near term.
For Parents and 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 dosage 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. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low levels of G6PD, which may increase the risk of developing anemia.
This medication can increase your susceptibility 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 complications.
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. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low levels of G6PD, which may increase the risk of developing anemia.
This medication can increase your susceptibility 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 complications.
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 (if significant absorption occurs): nausea, vomiting, diarrhea, dizziness, headache, fever, rash, blood dyscrasias (e.g., leukopenia, agranulocytosis), crystalluria, renal impairment.
- Symptoms of silver toxicity (argyria - rare with topical use): bluish-gray discoloration of skin, mucous membranes, and internal organs.
What to Do:
Discontinue use immediately. Seek emergency medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive and symptomatic. May involve hydration to prevent crystalluria and monitoring of blood counts and renal function.
Drug Interactions
Major Interactions
- Enzymatic debriding agents (e.g., collagenase, papain, sutilains): Silver can inactivate these enzymes. Avoid concurrent use.
Moderate Interactions
- Cimetidine: May increase the risk of leukopenia when co-administered with silver sulfadiazine, especially in burn patients.
- Phenytoin: Sulfonamides may inhibit phenytoin metabolism, potentially increasing phenytoin levels and toxicity (if significant systemic absorption occurs).
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for leukopenia, agranulocytosis, or aplastic anemia, which are rare but serious sulfonamide-related adverse effects, especially with extensive use or prolonged treatment.
Timing: Prior to initiation, especially if large burn areas are treated or prolonged therapy is anticipated.
Renal function (BUN, creatinine)
Rationale: To establish baseline and monitor for crystalluria or renal impairment, particularly if significant systemic absorption occurs.
Timing: Prior to initiation, especially if large burn areas are treated or prolonged therapy is anticipated.
Liver function tests (LFTs)
Rationale: To establish baseline and monitor for hepatic dysfunction, a rare sulfonamide-related adverse effect.
Timing: Prior to initiation, especially if large burn areas are treated or prolonged therapy is anticipated.
Routine Monitoring
Wound appearance and signs of infection
Frequency: Daily with dressing changes
Target: Clean, granulating wound; absence of purulence, erythema, warmth, or increasing pain.
Action Threshold: Worsening infection, non-healing wound, or signs of systemic infection.
Complete Blood Count (CBC) with differential
Frequency: Weekly, especially during prolonged treatment or if large burn areas are treated.
Target: WBC count within normal limits (e.g., 4,000-11,000/mm³), neutrophil count >1,500/mm³.
Action Threshold: Significant drop in WBC or neutrophil count, or development of agranulocytosis.
Renal function (BUN, creatinine, urine output)
Frequency: Periodically, especially during prolonged treatment or if large burn areas are treated.
Target: BUN and creatinine within normal limits, adequate urine output.
Action Threshold: Elevated BUN/creatinine, decreased urine output, or signs of crystalluria.
Symptom Monitoring
- Skin irritation (itching, burning, rash)
- Pain at application site
- Signs of systemic infection (fever, chills)
- Signs of sulfonamide hypersensitivity (rash, fever, facial swelling, difficulty breathing)
- Signs of blood dyscrasias (unusual bleeding/bruising, sore throat, fever, fatigue)
- Signs of renal dysfunction (decreased urine output, swelling)
- Signs of hepatic dysfunction (yellowing of skin/eyes, dark urine, abdominal pain)
Special Patient Groups
Pregnancy
Category B. While animal studies have not shown harm, adequate and well-controlled studies in pregnant women are lacking. Sulfonamides are generally avoided in late pregnancy (third trimester) due to the theoretical risk of kernicterus in the newborn by displacing bilirubin from albumin binding sites.
Trimester-Specific Risks:
First Trimester:
Low risk, but use only if clearly needed.
Second Trimester:
Low risk, but use only if clearly needed.
Third Trimester:
Avoid use, especially near term, due to theoretical risk of kernicterus in the neonate.
Lactation
L3 (Moderately Safe). Sulfonamides are excreted in breast milk. Due to the potential for kernicterus in jaundiced or premature infants, or infants with G6PD deficiency, use is generally not recommended in these populations. For healthy, full-term infants, use with caution and monitor for adverse effects (e.g., rash, diarrhea). Consider temporary discontinuation of breastfeeding or an alternative if large areas are treated or prolonged use is necessary.
Infant Risk:
Risk of kernicterus in jaundiced, premature, or G6PD-deficient infants. Low risk for healthy, full-term infants, but monitor for rash or diarrhea.
Pediatric Use
Contraindicated in premature infants and infants less than 2 months of age due to the risk of kernicterus. Use with caution in older infants and children, especially on large burn areas, due to potential for systemic absorption and sulfonamide-related adverse effects (e.g., blood dyscrasias, crystalluria).
Geriatric Use
No specific dose adjustments are typically needed. However, elderly patients may have reduced renal function, increasing the risk of systemic adverse effects if significant absorption occurs. Monitor renal function and CBC, especially with extensive use.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is for external use only. Do not ingest.
- Always apply to a clean, debrided wound surface.
- Maintain a continuous layer of cream over the wound at all times.
- The cream may cause a temporary grayish discoloration of the skin, especially if exposed to light.
- Monitor for signs of systemic absorption, particularly in patients with large burn areas, as this can lead to sulfonamide-related adverse effects (e.g., leukopenia, crystalluria).
- Avoid concurrent use with enzymatic debriding agents, as silver can inactivate them.
- Patients with G6PD deficiency should use with caution due to the risk of hemolysis if significant systemic absorption occurs.
Alternative Therapies
- Mafenide acetate (Sulfamylon) cream/solution (another topical antimicrobial for burns)
- Bacitracin ointment (for minor burns/wounds)
- Polymyxin B/Bacitracin/Neomycin ointment (Neosporin, for minor burns/wounds)
- Topical povidone-iodine (antiseptic, but less commonly used for extensive burns due to systemic absorption concerns)
- Honey-based dressings (for wound healing and antimicrobial properties)
- Advanced wound care dressings (e.g., hydrocolloids, hydrogels, silver-impregnated dressings without sulfadiazine)
Cost & Coverage
Average Cost:
$30 - $100 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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.