Silver Sulfadiazine 1% Cream 50gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical anti-infective
Pharmacologic Class
Sulfonamide derivative, topical antimicrobial
Pregnancy Category
Category B (first and second trimesters), Category D (third trimester, near term)
FDA Approved
Apr 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Silver sulfadiazine cream is a medicine applied to the skin to prevent and treat infections in severe burns. It contains a silver compound and an antibiotic (sulfadiazine) that work together to kill many types of bacteria and some fungi.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. 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 hands thoroughly 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 (about 1/16 inch or 1.5 mm) of cream to the entire affected area, ensuring the burn is always covered with cream.
- Reapply the cream if it is rubbed off or washed away.
- Keep the treated area covered with a sterile dressing if advised 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.
- Avoid prolonged exposure to sunlight or tanning beds while using this cream, 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. Reapply immediately if removed by patient activity.
Pediatric Dosing
Neonatal:
Contraindicated in premature and full-term infants less than 2 months of age due to risk of kernicterus.
Infant:
Contraindicated in infants less than 2 months of age. For infants > 2 months, use with caution; dose as per child, but monitor closely for adverse effects.
Child:
Apply 1% cream to the affected area once or twice daily, to a thickness of approximately 1/16 inch (1.5 mm). Use with caution, especially in children with G6PD deficiency.
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 for topical application, but monitor for systemic effects if large areas are treated.
Moderate:
No specific adjustment for topical application, but monitor for systemic effects if large areas are treated.
Severe:
No specific adjustment for topical application, but monitor for systemic effects if large areas are treated. Systemic absorption can lead to accumulation of sulfadiazine.
Dialysis:
Consider monitoring for systemic effects if large areas are treated, as sulfadiazine is dialyzable.
Hepatic Impairment:
Mild:
No specific adjustment for topical application, but monitor for systemic effects if large areas are treated.
Moderate:
No specific adjustment for topical application, but monitor for systemic effects if large areas are treated.
Severe:
No specific adjustment for topical application, but monitor for systemic effects if large areas are treated. Sulfadiazine is metabolized in the liver.
Pharmacology
Mechanism of Action
Silver sulfadiazine acts on the cell membrane and cell wall of bacteria. The silver component is thought to exert its antimicrobial effect by binding to bacterial DNA and proteins, disrupting cell wall integrity and metabolic processes. The sulfadiazine component, a sulfonamide, inhibits bacterial dihydrofolate synthetase, an enzyme essential for bacterial folic acid synthesis, thereby interfering with bacterial growth and replication. This dual mechanism provides broad-spectrum antibacterial activity against many Gram-positive and Gram-negative bacteria, as well as some yeasts.
Pharmacokinetics
Absorption:
Bioavailability:
Limited systemic absorption (approximately 1% of silver and 10% of sulfadiazine) from burn wounds, but can be higher with extensive burns or prolonged use.
Tmax:
Not precisely defined for topical application; systemic peak concentrations of sulfadiazine can occur within hours to days depending on extent of absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely defined for topical application; systemically absorbed sulfadiazine distributes widely.
ProteinBinding:
Sulfadiazine: Approximately 50-60% protein bound.
CnssPenetration:
Limited for silver sulfadiazine itself; systemically absorbed sulfadiazine can penetrate the CNS.
Elimination:
HalfLife:
Sulfadiazine: Approximately 10 hours (systemically absorbed).
Clearance:
Not precisely defined for topical application; systemically absorbed sulfadiazine is primarily renally cleared.
ExcretionRoute:
Mainly renal excretion (sulfadiazine and its metabolites).
Unchanged:
Approximately 30% of systemically absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid antimicrobial action upon application.
PeakEffect:
Continuous antimicrobial activity as long as the cream is present on the wound.
DurationOfAction:
Maintained until the cream is removed or absorbed/inactivated, typically requiring 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 or seek medical attention immediately:
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
Difficulty urinating or 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, 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
+ Any 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 may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Changes in skin color
Skin irritation
This is not an exhaustive list of all 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 or seek medical attention immediately:
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
Difficulty urinating or 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, 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
+ Any 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 may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Changes in skin color
Skin irritation
This is not an exhaustive list of all 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: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of worsening infection: increased redness, swelling, pain, pus, fever.
- Signs of blood problems: unusual tiredness, weakness, pale skin, easy bruising or bleeding, sore throat, fever, chills.
- Skin discoloration (bluish-gray) in the treated area (argyria), especially with prolonged use or on large areas.
- Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) - rare but serious: blistering, peeling skin, rash.
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.
Additionally, this medication may interact with other medications or health conditions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have.
To ensure safe use, always verify with your doctor that it is safe to take this medication with your other medications and health conditions. Never 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 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.
Additionally, this medication may interact with other medications or health conditions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have.
To ensure safe use, always verify with your doctor that it is safe to take this medication with your other medications and health conditions. Never 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 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 case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
This medication may interfere with certain laboratory tests. Ensure that your doctor and laboratory personnel are aware that you are taking this drug 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, 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 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 case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
This medication may interfere with certain laboratory tests. Ensure that your doctor and laboratory personnel are aware that you are taking this drug 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, abdominal pain, dizziness, headache, fever, rash, blood dyscrasias (e.g., leukopenia, thrombocytopenia), crystalluria, renal impairment.
What to Do:
Discontinue use. Seek immediate medical attention. Treatment is supportive and symptomatic. In case of accidental ingestion or significant systemic absorption, call a poison control center (e.g., 1-800-222-1222) or emergency services.
Drug Interactions
Contraindicated Interactions
- Enzyme debriding agents (e.g., collagenase, papain, sutilains) - silver can inactivate these enzymes.
Major Interactions
- Cimetidine (increased risk of leukopenia)
- Oral hypoglycemics (sulfonylureas) - increased hypoglycemic effect due to displacement from protein binding or inhibition of metabolism by sulfadiazine.
- Phenytoin - increased phenytoin levels due to inhibition of metabolism by sulfadiazine.
- Warfarin - increased anticoagulant effect due to displacement from protein binding or inhibition of metabolism by sulfadiazine.
Moderate Interactions
- Diuretics (thiazides, furosemide) - increased risk of thrombocytopenia with purpura.
- Methotrexate - increased methotrexate toxicity due to displacement from protein binding or inhibition of renal excretion by sulfadiazine.
- Other sulfonamides - additive effects and increased risk of adverse reactions.
Monitoring
Baseline Monitoring
Extent and depth of burn wound
Rationale: To assess the severity and guide treatment.
Timing: Prior to initiation of therapy.
Signs of infection
Rationale: To determine the presence of existing infection and monitor response to therapy.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for leukopenia, a common adverse effect.
Timing: Prior to initiation of therapy, especially if large areas are treated.
Routine Monitoring
Wound healing progress
Frequency: Daily
Target: Reduction in wound size, healthy granulation tissue, absence of purulence.
Action Threshold: Lack of healing, worsening infection, or signs of systemic toxicity.
Signs of local infection (e.g., redness, swelling, pain, purulence)
Frequency: Daily
Target: Absence of signs of infection.
Action Threshold: Presence or worsening of infection signs.
Complete Blood Count (CBC) with differential
Frequency: Every 2-4 days, especially during the first few days of therapy or if large areas are treated.
Target: WBC count within normal limits (typically >4,000 cells/mm³).
Action Threshold: Significant drop in WBC count, particularly below 2,000-3,000 cells/mm³ (leukopenia).
Renal function (BUN, creatinine)
Frequency: Periodically, especially with extensive burns or prolonged use.
Target: Within normal limits.
Action Threshold: Significant elevation indicating renal impairment.
Liver function tests (ALT, AST)
Frequency: Periodically, especially with extensive burns or prolonged use.
Target: Within normal limits.
Action Threshold: Significant elevation indicating hepatic impairment.
Symptom Monitoring
- Skin irritation (itching, burning, rash)
- Allergic reactions (hives, swelling, difficulty breathing)
- Fever
- Sore throat
- Unusual bleeding or bruising
- Fatigue or weakness (signs of blood dyscrasias)
- Nausea, vomiting, diarrhea
- Signs of methemoglobinemia (cyanosis, shortness of breath, fatigue) - rare
Special Patient Groups
Pregnancy
Use with caution during pregnancy. Category B for first and second trimesters, but Category D in the third trimester (near term) due to the risk of kernicterus in the newborn from systemic absorption of sulfadiazine. Avoid use in pregnant women at term or near term.
Trimester-Specific Risks:
First Trimester:
Limited data, generally considered low risk for topical use, but systemic absorption is possible.
Second Trimester:
Limited data, generally considered low risk for topical use, but systemic absorption is possible.
Third Trimester:
Contraindicated near term due to risk of kernicterus in the newborn (sulfonamides displace bilirubin from albumin binding sites).
Lactation
Contraindicated in breastfeeding mothers of premature infants or infants less than 2 months of age due to the risk of kernicterus. Use with caution in breastfeeding mothers of older infants, monitoring for adverse effects in the infant (e.g., jaundice, rash).
Infant Risk:
High risk for neonates/premature infants (kernicterus). Moderate risk for older infants (potential for jaundice, rash, G6PD hemolytic anemia).
Pediatric Use
Contraindicated in premature and full-term infants less than 2 months of age due to the risk of kernicterus. Use with caution in older children, especially those with G6PD deficiency, due to the risk of hemolytic anemia. Monitor CBC closely.
Geriatric Use
No specific dose adjustments are typically required. However, elderly patients may be more susceptible to adverse effects due to age-related decline in renal or hepatic function, or concomitant medications. Monitor for systemic adverse effects, especially if large areas are treated.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is a first-line topical agent for burn wound management due to its broad-spectrum activity and ease of application.
- Ensure the burn wound is always covered with a layer of cream; reapply if it gets rubbed off.
- Monitor for leukopenia (low white blood cell count), which is a common side effect, especially during the first few days of treatment. A transient drop in WBC count is often observed.
- Patients with G6PD deficiency are at increased risk of hemolytic anemia with sulfonamide exposure; use with extreme caution or avoid.
- Avoid use with enzymatic debriding agents as silver can inactivate them.
- Prolonged use or application to very large areas can lead to significant systemic absorption, increasing the risk of sulfonamide-related adverse effects (e.g., renal impairment, blood dyscrasias, crystalluria).
- Protect treated areas from direct sunlight due to potential for photosensitivity.
Alternative Therapies
- Mafenide acetate cream (Sulfamylon)
- Bacitracin/Polymyxin B topical (for superficial burns)
- Povidone-iodine topical
- Topical antibiotics (e.g., neomycin, gentamicin) - generally less preferred for extensive burns
- Honey dressings
- Biologic dressings (e.g., allografts, xenografts)
- Synthetic dressings
Cost & Coverage
Average Cost:
$20 - $60 per 50gm tube of 1% cream
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 for further evaluation and guidance. To ensure your safety, never share your medication with others or take someone else's medication, as this can lead to adverse reactions or interactions. Some medications may have additional patient information leaflets; consult with your pharmacist to determine if this applies to your prescription. If you have any questions or concerns about your 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred, to facilitate prompt and effective treatment.