Silver Sulfadiazine Cream 50gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical Anti-infective
Pharmacologic Class
Sulfonamide Antimicrobial; Silver Salt
Pregnancy Category
Category B
FDA Approved
Sep 1968
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 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. 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 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
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 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
- Keep the burn wound clean and follow your healthcare provider's instructions for wound care.
- Apply the cream exactly as directed, usually once or twice a day, to cover the entire burn area.
- Wear sterile gloves when applying the cream to prevent contamination.
- Keep the treated area covered with a dressing as instructed by your doctor.
- Avoid getting the cream in your eyes or mouth.
- Stay hydrated and maintain good nutrition to support wound healing.
Available Forms & 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:
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, consult specialist; dosing similar to child, but with extreme caution.
Child:
Apply to a thickness of approximately 1/16 inch (1.5 mm) once or twice daily to cleansed and debrided burn wounds. Reapply if removed by patient activity or hydrotherapy.
Adolescent:
Apply to a thickness of approximately 1/16 inch (1.5 mm) once or twice daily to cleansed and debrided burn wounds. Reapply if removed by patient activity or hydrotherapy.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution, especially with extensive burns, due to potential for systemic absorption.
Moderate:
Use with caution, especially with extensive burns; monitor renal function and CBC.
Severe:
Use with caution, especially with extensive burns; monitor renal function and CBC closely. Consider alternative if possible.
Dialysis:
Not specifically studied for topical application in dialysis patients. Use with caution and monitor for systemic effects if significant absorption is anticipated.
Hepatic Impairment:
Mild:
Use with caution, especially with extensive burns, due to potential for systemic absorption.
Moderate:
Use with caution, especially with extensive burns; monitor liver function and CBC.
Severe:
Use with caution, especially with extensive burns; monitor liver function and CBC closely. Consider alternative if possible.
Pharmacology
Mechanism of Action
Silver sulfadiazine acts on the bacterial cell wall and membrane to disrupt their integrity, and also interferes with DNA replication and transcription. The sulfadiazine component inhibits bacterial dihydrofolate reductase, an enzyme essential for bacterial folic acid synthesis, thus exerting a bacteriostatic effect. The silver component is thought to be the primary antimicrobial agent, with the sulfadiazine component contributing to the broad spectrum of activity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 1% of silver and 5-10% of sulfadiazine may be absorbed systemically, depending on the extent and depth of the burn wound.
Tmax:
Not precisely defined for topical application; systemic absorption is gradual and sustained.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not available for topical application; systemically absorbed sulfadiazine distributes widely.
ProteinBinding:
Sulfadiazine is approximately 85-90% protein bound.
CnssPenetration:
Limited for silver; sulfadiazine can penetrate CNS to some extent if systemically absorbed.
Elimination:
HalfLife:
Systemically absorbed sulfadiazine has a half-life of approximately 10 hours.
Clearance:
Not available for topical application.
ExcretionRoute:
Systemically absorbed sulfadiazine and its metabolites are primarily excreted in the urine.
Unchanged:
Approximately 30% of systemically absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid antimicrobial action upon application.
PeakEffect:
Not precisely defined for topical application.
DurationOfAction:
Maintained as long as the cream is present on the wound surface, typically 12-24 hours per application.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Difficulty urinating or a change in urine output
Severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
If you experience any of the following symptoms, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
+ Fever, chills, or sore throat
+ New or worsening cough
+ Feeling very tired or weak
+ Bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor or seek medical help:
Change 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Difficulty urinating or a change in urine output
Severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
If you experience any of the following symptoms, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
+ Fever, chills, or sore throat
+ New or worsening cough
+ Feeling very tired or weak
+ Bruising or bleeding
+ Signs of liver problems, such as:
- Dark urine
- Tiredness
- Decreased appetite
- Upset stomach or stomach pain
- Light-colored stools
- Vomiting
- Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor or seek medical help:
Change 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 allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of worsening infection (increased redness, swelling, pain, pus, fever)
- Unusual tiredness or weakness
- Pale skin, easy bruising or bleeding (signs of blood problems)
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe skin rash or blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Nausea, vomiting, loss of appetite
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 or Caregivers:
If your child is a premature baby or 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.
Potential Interactions:
This medication may interact with other medications or health conditions. Therefore, it is crucial to inform your doctor and pharmacist about:
+ All prescription and over-the-counter (OTC) medications you are taking.
+ Any natural products or vitamins you are using.
+ Your health problems.
* Before taking this medication, ensure it is safe to use with your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any 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 Parents or Caregivers:
If your child is a premature baby or 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.
Potential Interactions:
This medication may interact with other medications or health conditions. Therefore, it is crucial to inform your doctor and pharmacist about:
+ All prescription and over-the-counter (OTC) medications you are taking.
+ Any natural products or vitamins you are using.
+ Your health problems.
* Before taking this medication, ensure it is safe to use with your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any 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 levels of G6PD.
This medication can increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to sunlight, and notify your doctor if you experience 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, as this condition may increase your risk of developing anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low levels of G6PD.
This medication can increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to sunlight, and notify your doctor if you experience 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:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Confusion
- Jaundice
- Cyanosis
- Blood dyscrasias (e.g., leukopenia, thrombocytopenia)
What to Do:
If you suspect an overdose or significant systemic absorption, seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive and symptomatic, potentially including fluid administration to promote renal excretion.
Drug Interactions
Major Interactions
- Enzymatic debriding agents (e.g., collagenase, sutilains, papain): Silver can inactivate these enzymes. Concurrent use is not recommended.
Moderate Interactions
- Cimetidine: Concurrent use has been rarely associated with transient leukopenia and agranulocytosis.
- Systemic sulfonamides: Potential for additive systemic effects if significant absorption occurs.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline hematologic parameters and monitor for leukopenia, which can occur with systemic absorption.
Timing: Prior to initiation of therapy, especially for extensive burns.
Renal function (BUN, creatinine)
Rationale: To establish baseline renal function and monitor for potential impairment, especially with significant systemic absorption.
Timing: Prior to initiation of therapy, especially for extensive burns.
Liver function tests (ALT, AST, bilirubin)
Rationale: To establish baseline hepatic function and monitor for potential impairment, especially with significant systemic absorption.
Timing: Prior to initiation of therapy, especially for extensive burns.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Every 2-3 days during initial treatment, then weekly or as clinically indicated.
Target: Within normal limits; monitor for leukopenia (especially transient) or other dyscrasias.
Action Threshold: Significant drop in WBC count (e.g., < 4,000/mm³) or development of agranulocytosis; consider discontinuation or alternative therapy.
Renal function (BUN, creatinine)
Frequency: Weekly or as clinically indicated, especially with extensive burns.
Target: Within normal limits.
Action Threshold: Significant increase in BUN/creatinine; consider dose adjustment or alternative therapy.
Liver function tests (ALT, AST, bilirubin)
Frequency: Weekly or as clinically indicated, especially with extensive burns.
Target: Within normal limits.
Action Threshold: Significant increase in liver enzymes; consider discontinuation or alternative therapy.
Wound assessment
Frequency: Daily with dressing changes.
Target: Signs of healing, reduction in infection.
Action Threshold: Signs of worsening infection, delayed healing, or adverse skin reactions (e.g., rash, irritation).
Symptom Monitoring
- Fever
- Chills
- Sore throat (signs of infection/blood dyscrasias)
- Unusual bleeding or bruising
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe skin rash or blistering
- Pain or burning at application site
- Signs of superinfection (e.g., fungal growth)
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 at or near term (late pregnancy) due to the theoretical risk of kernicterus in the neonate from systemic absorption of sulfadiazine.
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:
Avoid at or near term (late pregnancy) due to theoretical risk of kernicterus in the neonate.
Lactation
L3 (Moderately Safe). Sulfonamides are excreted in breast milk and can cause kernicterus in jaundiced, ill, or premature infants. Use with caution. Avoid if infant is jaundiced, premature, or has G6PD deficiency.
Infant Risk:
Potential for kernicterus in susceptible infants (premature, jaundiced, G6PD deficient). Monitor infant for signs of jaundice or adverse effects.
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 pediatric patients; monitor for systemic absorption and adverse effects, especially hematologic changes.
Geriatric Use
No specific dose adjustments are typically required based solely on age. However, geriatric patients may have reduced renal function, which could increase systemic exposure if significant absorption occurs. Monitor renal function and CBC closely, especially with extensive burns.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is a broad-spectrum antimicrobial effective against many gram-positive and gram-negative bacteria, as well as some fungi, commonly found in burn wounds.
- It is important to remove any residual cream and wound exudate before reapplication to ensure optimal contact with the wound surface.
- Transient leukopenia (low white blood cell count) is a common side effect, usually occurring 2-4 days after initiation of therapy and often resolving spontaneously despite continued treatment. Close monitoring of CBC is crucial.
- The cream should be applied with sterile gloves to prevent contamination of the wound.
- Patients with G6PD deficiency should be monitored closely for hemolytic anemia due to the sulfonamide component.
- Avoid use on the face if possible, as it can cause argyria (silver discoloration) with prolonged use, though rare with topical application.
Alternative Therapies
- Mafenide acetate (Sulfamylon) cream/solution
- Topical antibiotics (e.g., bacitracin, polymyxin B, neomycin) for superficial burns or specific infections
- Honey dressings (medical grade)
- Povidone-iodine (caution with large areas due to iodine absorption)
- Chlorhexidine (for wound cleansing)
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 is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 substance taken, the amount, and the time it occurred.