Silver Sulfadiazine 1% Cream 20gm
It is used to avoid or treat skin infections in patients with burns.
Drug Class
Topical Anti-infective
Pharmacologic Class
Sulfonamide Derivative; Silver Compound
Pregnancy Category
Category B
FDA Approved
Jun 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Silver sulfadiazine cream is a medicine applied to burns to prevent and treat infections. It contains silver and a sulfa drug 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 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 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 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 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 a sterile dressing as directed by your doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Wash hands thoroughly before and after applying the cream.
- Do not use on healthy skin or for conditions other than those prescribed.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm).
Condition-Specific Dosing:
burnWounds:
Cleanse and debride the wound prior to application. Reapply if removed by patient activity or hydrotherapy.
Pediatric Dosing
Neonatal:
Not established (Contraindicated in premature and full-term infants less than 2 months of age due to risk of kernicterus).
Infant:
Not established (Contraindicated in infants less than 2 months of age).
Child:
Apply to 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 to 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 use, but monitor for systemic adverse effects if significant absorption occurs.
Moderate:
No specific adjustment for topical use, but monitor for systemic adverse effects if significant absorption occurs.
Severe:
No specific adjustment for topical use, but monitor for systemic adverse effects if significant absorption occurs.
Dialysis:
Consider monitoring for systemic adverse effects if large surface areas are treated.
Hepatic Impairment:
Mild:
No specific adjustment for topical use, but monitor for systemic adverse effects if significant absorption occurs.
Moderate:
No specific adjustment for topical use, but monitor for systemic adverse effects if significant absorption occurs.
Severe:
No specific adjustment for topical use, but monitor for systemic adverse effects if significant absorption occurs.
Pharmacology
Mechanism of Action
Silver sulfadiazine acts on the bacterial cell wall and cell membrane. The silver component is released slowly and exerts an antiseptic effect by binding to bacterial DNA and proteins, disrupting cell function. The sulfadiazine component, a sulfonamide, interferes with bacterial folic acid synthesis (PABA antagonism), inhibiting bacterial growth. The combination 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 may be absorbed from burn wounds).
Tmax:
Not well-defined for topical application; systemic peak concentrations are low and variable.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not available for topical application.
ProteinBinding:
Sulfadiazine is approximately 50% protein bound in plasma.
CnssPenetration:
Limited (sulfadiazine can cross the blood-brain barrier to some extent if systemically absorbed).
Elimination:
HalfLife:
Not well-defined for topical application; systemic sulfadiazine half-life is 10-12 hours.
Clearance:
Not available for topical application.
ExcretionRoute:
Primarily renal (sulfadiazine and its metabolites).
Unchanged:
Not available for topical application.
Pharmacodynamics
OnsetOfAction:
Rapid (antimicrobial effect begins upon contact with the wound).
PeakEffect:
Not well-defined for topical application.
DurationOfAction:
Approximately 24 hours (requires daily 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 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
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
If you experience any of the following symptoms, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
+ Fever, chills, or sore throat
+ New or worsening cough
+ Feeling 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 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 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 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
Rare but severe effects associated with sulfa drugs, including:
+ Liver problems
+ Blood problems
+ Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis)
If you experience any of the following symptoms, call your doctor right away:
+ Rash
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
+ Fever, chills, or sore throat
+ New or worsening cough
+ Feeling 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 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 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:
- New or worsening redness, swelling, pain, or pus around the burn.
- Fever or chills.
- Skin rash, itching, or hives.
- Unusual tiredness or weakness.
- Sore throat or mouth sores.
- Unexplained bruising or bleeding.
- Yellowing of the skin or eyes (jaundice).
- Dark urine.
- Bluish discoloration of the skin (rare).
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, particularly if you are near term.
For Parents or 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, particularly if you are near term.
For Parents or 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 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 using this medication to 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 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 using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of systemic sulfonamide toxicity (nausea, vomiting, diarrhea, dizziness, headache, confusion, crystalluria, blood dyscrasias like leukopenia or thrombocytopenia).
- Symptoms of silver toxicity (argyria - bluish skin discoloration, though rare with topical overdose).
What to Do:
Immediately wash off the excess cream. Seek emergency medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic.
Drug Interactions
Contraindicated Interactions
- Enzymatic debriding agents (e.g., collagenase, papain, sutilains) - silver can inactivate these enzymes.
Moderate Interactions
- Cimetidine (may increase risk of leukopenia)
- Oral hypoglycemics (sulfonylureas) - theoretical risk of enhanced hypoglycemic effect if significant sulfadiazine absorption occurs.
- Phenytoin - theoretical risk of increased phenytoin levels if significant sulfadiazine absorption occurs.
- Warfarin - theoretical risk of enhanced anticoagulant effect if significant sulfadiazine absorption occurs.
Monitoring
Baseline Monitoring
Wound assessment (size, depth, presence of infection)
Rationale: To establish baseline for treatment efficacy and identify signs of infection.
Timing: Prior to first application.
Complete Blood Count (CBC) with differential
Rationale: To monitor for leukopenia, a potential adverse effect of sulfonamides, especially with large surface area burns.
Timing: Prior to initiation of therapy, especially if large surface areas are involved.
Renal function (BUN, creatinine)
Rationale: To assess baseline renal function, as sulfadiazine is renally excreted.
Timing: Prior to initiation of therapy, especially if large surface areas are involved.
Routine Monitoring
Wound appearance (signs of healing, infection, eschar formation)
Frequency: Daily with dressing changes.
Target: Improvement in wound appearance, reduction in exudate, absence of purulence.
Action Threshold: Worsening infection, persistent purulence, or lack of healing may indicate need for alternative therapy or systemic antibiotics.
Complete Blood Count (CBC) with differential
Frequency: Twice weekly or as clinically indicated, especially during prolonged treatment or large surface area burns.
Target: WBC count within normal limits (e.g., 4,000-11,000/mm³).
Action Threshold: Leukopenia (WBC < 3,000/mm³) may necessitate discontinuation or dose adjustment.
Renal function (BUN, creatinine)
Frequency: Weekly or as clinically indicated, especially during prolonged treatment or large surface area burns.
Target: BUN and creatinine within normal limits.
Action Threshold: Significant elevation may indicate renal impairment, requiring re-evaluation of therapy.
Serum electrolytes (especially chloride)
Frequency: As clinically indicated, especially with large surface area burns.
Target: Within normal limits.
Action Threshold: Hypochloremia or metabolic acidosis may occur due to carbonic anhydrase inhibition.
Symptom Monitoring
- Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
- Signs of systemic infection (fever, chills, increased pain, redness, swelling around wound)
- Signs of sulfonamide-related adverse effects (sore throat, fever, unusual bleeding or bruising, jaundice, dark urine, severe skin rash)
- Signs of argyria (bluish discoloration of skin or mucous membranes - rare with topical use)
Special Patient Groups
Pregnancy
Use with caution during pregnancy. Category B. Avoid use in late pregnancy (third trimester) due to theoretical risk of kernicterus in the newborn.
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 use, especially near term, due to the risk of kernicterus in the neonate from absorbed sulfadiazine.
Lactation
L3 - Moderately safe. Use with caution. Sulfonamides are excreted in breast milk and can cause kernicterus in infants with hyperbilirubinemia or G6PD deficiency. Avoid use if the infant is premature, jaundiced, or has G6PD deficiency.
Infant Risk:
Risk of kernicterus in susceptible infants (premature, jaundiced, G6PD deficient). Monitor infant for jaundice.
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.
Geriatric Use
No specific dose adjustments needed. Use with caution in patients with impaired renal or hepatic function, as systemic absorption can occur, and these patients may be more susceptible to adverse effects.
Clinical Information
Clinical Pearls
- Always cleanse and debride the burn wound thoroughly before applying silver sulfadiazine cream.
- Apply the cream in a thin layer (approximately 1/16 inch or 1.5 mm) to ensure continuous coverage.
- Reapply the cream if it is removed by patient activity or hydrotherapy.
- Monitor for signs of systemic absorption, especially in patients with large surface area burns, as this can lead to sulfonamide-related adverse effects (e.g., leukopenia, rash, renal dysfunction).
- Avoid concomitant use with enzymatic debriding agents, as silver can inactivate them.
- Not indicated for use in neonates due to the risk of kernicterus.
Alternative Therapies
- Mafenide acetate cream (Sulfamylon)
- Bacitracin/Polymyxin B (topical antibiotics for minor burns)
- Povidone-iodine (topical antiseptic)
- Honey dressings (for wound healing)
- Topical antiseptics (e.g., chlorhexidine) for wound care
Cost & Coverage
Average Cost:
$15 - $50 per 20gm 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 promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this 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.