Silver Sulfadiazine Cream 400gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical anti-infective, burn treatment
Pharmacologic Class
Sulfonamide antibiotic, silver salt
Pregnancy Category
Category B (first and second trimesters), Category D (third trimester, near term, or in premature infants/neonates)
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 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
Do not take this medication by mouth. It is for topical use only, and you should avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should 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, avoiding bathrooms and areas where children and pets can access it.
Keep all medications in a safe location, out of 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, and consider participating in local drug take-back programs.
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
Do not take this medication by mouth. It is for topical use only, and you should avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should 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, avoiding bathrooms and areas where children and pets can access it.
Keep all medications in a safe location, out of 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, and consider participating in local drug take-back programs.
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
- 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 the cream to cover the entire burn surface, usually about 1/16 inch thick. The cream should be present on the burn at all times.
- Reapply the cream if it is rubbed off or removed during activity.
- Keep the treated area covered with the cream and, if directed, with a sterile dressing.
- 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.
- Report any signs of infection (e.g., pus, redness, fever) or allergic reaction (e.g., severe rash, swelling) to your doctor immediately.
- Stay hydrated as directed by your healthcare provider, especially with large burns.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a 1% cream to the affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm). The burn wound should be covered with the cream at all times.
Condition-Specific Dosing:
burns:
Apply to cleansed and debrided burn wounds once or twice daily. Reapply if removed by patient activity.
Pediatric Dosing
Neonatal:
Contraindicated in premature infants and neonates during the first 2 months of life due to the risk of kernicterus.
Infant:
Contraindicated in infants less than 2 months of age. For infants >2 months, use with extreme caution, considering potential for systemic absorption and kernicterus risk.
Child:
Apply as for adults, but with caution regarding systemic absorption, especially in large surface area burns. Monitor for sulfonamide-related adverse effects.
Adolescent:
Apply as for adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for topical use, but monitor for systemic adverse effects if large areas are treated.
Moderate:
Use with caution, especially if large body surface areas are treated, due to potential for systemic absorption and accumulation of sulfadiazine. Monitor renal function and CBC.
Severe:
Use with extreme caution or avoid, especially if large body surface areas are treated, due to potential for systemic absorption and accumulation of sulfadiazine. Monitor renal function and CBC closely.
Dialysis:
Not well-studied for topical use in dialysis patients. If systemic absorption is significant, consider potential for accumulation. Consult nephrologist.
Hepatic Impairment:
Mild:
No specific adjustment for topical use.
Moderate:
Use with caution, especially if large body surface areas are treated, due to potential for systemic absorption and hepatic metabolism of sulfadiazine. Monitor liver function tests.
Severe:
Use with extreme caution or avoid, especially if large body surface areas are treated, due to potential for systemic absorption and hepatic metabolism of sulfadiazine. Monitor liver function tests closely.
Pharmacology
Mechanism of Action
Silver sulfadiazine acts on the cell membrane and cell wall of bacteria. The silver component is thought to bind to bacterial DNA, inhibiting replication and transcription. The sulfadiazine component, a sulfonamide antibiotic, interferes with bacterial folic acid synthesis by inhibiting dihydropteroate synthase, an enzyme essential for the incorporation of para-aminobenzoic acid (PABA) into folic acid. This dual mechanism provides broad-spectrum antimicrobial activity against many Gram-positive and Gram-negative bacteria, as well as some fungi.
Pharmacokinetics
Absorption:
Bioavailability:
Limited systemic absorption; approximately 1-10% of the sulfadiazine and 0.2-1% of the silver may be absorbed, depending on the extent of the burn and duration of treatment.
Tmax:
Not applicable for topical action; systemic absorption peak concentrations are variable and depend on burn size and integrity of skin barrier.
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not well-defined for topical application; systemically absorbed sulfadiazine distributes into extracellular fluid.
ProteinBinding:
Sulfadiazine is approximately 40-60% protein bound.
CnssPenetration:
Limited (for systemically absorbed sulfadiazine, can cross blood-brain barrier to some extent).
Elimination:
HalfLife:
Systemically absorbed sulfadiazine has a half-life of approximately 10 hours.
Clearance:
Not well-defined for topical application; systemic clearance is primarily renal.
ExcretionRoute:
Renal (unchanged drug and metabolites).
Unchanged:
Approximately 50-60% of systemically absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Immediate (topical antimicrobial effect).
PeakEffect:
Continuous as long as cream is applied.
DurationOfAction:
Continuous as long as cream is applied and not removed.
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
Urination problems, such as:
+ Inability to pass urine
+ Changes in the amount of urine passed
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 experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
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.
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
Urination problems, such as:
+ Inability to pass urine
+ Changes in the amount of urine passed
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 experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
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:
- Severe skin rash, blistering, or peeling (signs of severe skin reactions like Stevens-Johnson syndrome)
- Unusual bleeding or bruising
- Sore throat, fever, or chills (signs of low white blood cell count)
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Changes in how much you urinate
- Persistent nausea, vomiting, or diarrhea
- Signs of a new infection (e.g., worsening redness, pus, pain, or fever)
- Allergic reactions such as swelling of the face, lips, tongue, or throat, difficulty breathing.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the symptoms you experienced during an allergic reaction.
A known sulfa allergy.
If you are pregnant, especially near term.
For Parents 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 during an allergic reaction.
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, 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 easy sunburning while taking this drug.
Do not use this medication for a longer duration than prescribed, as this may lead to the development of a secondary infection.
In 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 using 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 using this medication, both for 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 easy sunburning while taking this drug.
Do not use this medication for a longer duration than prescribed, as this may lead to the development of a secondary infection.
In 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 using 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 using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Fever
- Jaundice
- Crystalluria (crystals in urine)
- Renal failure
- Bone marrow depression (e.g., leukopenia, thrombocytopenia, aplastic anemia)
What to Do:
Overdose from topical application is rare but possible with extensive use on large burn areas. If systemic toxicity is suspected, discontinue the cream. Treatment is supportive and symptomatic. Maintain adequate hydration to prevent crystalluria. Monitor blood counts, renal function, and liver function. In case of suspected overdose, call 911 or Poison Control at 1-800-222-1222 immediately.
Drug Interactions
Major Interactions
- Enzymatic debriding agents (e.g., collagenase, papain, sutilains): Silver can inactivate these enzymes, reducing their effectiveness. Avoid concomitant use.
Moderate Interactions
- Cimetidine: Concomitant use with silver sulfadiazine has been reported to increase the incidence of leukopenia, possibly due to increased systemic absorption of sulfadiazine.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To establish baseline values and monitor for potential leukopenia, which is a common adverse effect, especially with large surface area burns.
Timing: Prior to initiation of therapy, especially if large burn areas are involved.
Renal function tests (BUN, creatinine)
Rationale: To assess baseline renal function, as sulfadiazine and its metabolites are primarily renally excreted. Important for patients with pre-existing renal impairment.
Timing: Prior to initiation of therapy, especially if large burn areas are involved or in patients with renal impairment.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, as sulfadiazine is metabolized in the liver. Important for patients with pre-existing hepatic impairment.
Timing: Prior to initiation of therapy, especially if large burn areas are involved or in patients with hepatic impairment.
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 significant drops in white blood cell count.
Action Threshold: If WBC count drops significantly (e.g., <3,000/mm³) or neutropenia develops, consider temporary discontinuation or alternative therapy and investigate cause.
Renal function tests (BUN, creatinine)
Frequency: Weekly or as clinically indicated, especially in patients with large burns or pre-existing renal impairment.
Target: Within normal limits.
Action Threshold: Significant increase in BUN/creatinine may indicate renal impairment or accumulation of sulfadiazine; adjust therapy or discontinue if necessary.
Liver function tests (ALT, AST, bilirubin)
Frequency: Weekly or as clinically indicated, especially in patients with large burns or pre-existing hepatic impairment.
Target: Within normal limits.
Action Threshold: Significant increase in liver enzymes may indicate hepatic toxicity; adjust therapy or discontinue if necessary.
Wound assessment
Frequency: Daily with dressing changes.
Target: Clean, granulating wound bed, absence of signs of infection.
Action Threshold: Signs of infection (pus, increasing erythema, fever), delayed healing, or adverse skin reactions (rash, itching) warrant re-evaluation of therapy.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Unusual bleeding or bruising
- Fatigue
- Skin rash (including Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Itching
- Burning sensation at application site
- Pain at application site
- Nausea
- Vomiting
- Diarrhea
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Changes in urine output
- Signs of superinfection (e.g., fungal infection)
Special Patient Groups
Pregnancy
Category B for first and second trimesters; Category D for third trimester, near term, or in premature infants/neonates. Avoid use in the third trimester or near term due to the risk of kernicterus in the newborn, as sulfonamides can displace bilirubin from albumin binding sites.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk for topical use. Systemic absorption is minimal.
Second Trimester:
Limited data, but generally considered low risk for topical use. Systemic absorption is minimal.
Third Trimester:
Category D. Avoid use, especially near term, due to the risk of kernicterus in the newborn. Sulfonamides can cross the placenta and compete with bilirubin for binding sites on albumin.
Lactation
L4 - Potentially hazardous. Sulfonamides are excreted in breast milk and can cause kernicterus in jaundiced or premature infants, or infants with G6PD deficiency. It is generally recommended to avoid use during breastfeeding, especially if the infant is premature, jaundiced, or has G6PD deficiency.
Infant Risk:
High risk for kernicterus in susceptible infants (premature, jaundiced, G6PD deficient). Moderate risk for other infants.
Pediatric Use
Contraindicated in premature infants and neonates during the first 2 months of life due to the risk of kernicterus. Use with extreme caution in infants and young children due to the potential for systemic absorption and sulfonamide-related adverse effects. Monitor CBC closely.
Geriatric Use
Use with caution in elderly patients, especially those with impaired renal or hepatic function, due to potential for systemic absorption and accumulation. Monitor renal function, liver function, and CBC closely.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is for external use only. Do not ingest.
- The cream should be applied to a thickness of approximately 1/16 inch (1.5 mm) to ensure continuous coverage of the burn wound.
- Leukopenia is a common adverse effect, especially during the first few days of treatment and with large burn areas. Regular CBC monitoring is crucial.
- Avoid use with enzymatic debriding agents as silver can inactivate them.
- Contraindicated in premature infants and neonates due to the risk of kernicterus.
- Patients with G6PD deficiency may be at increased risk of hemolysis with systemic absorption of sulfadiazine.
- Prolonged use or use on large areas may lead to systemic absorption and sulfonamide-related adverse effects, including crystalluria, renal toxicity, and hepatic toxicity. Ensure adequate hydration.
Alternative Therapies
- Mafenide acetate cream (Sulfamylon)
- Povidone-iodine (topical)
- Bacitracin/Polymyxin B (topical)
- Honey dressings
- Biological dressings (e.g., allografts, xenografts)
- Synthetic dressings (e.g., hydrocolloids, hydrogels)
Cost & Coverage
Average Cost:
$100 - $300 per 400gm cream
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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; consult your pharmacist for more information. If you have any questions or concerns about this medication, 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 details about the medication taken, the quantity, and the time it occurred.