Silvadene 1% Cream 1000gm
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
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.
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Before and after application, wash your hands thoroughly, 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, removing any dead skin, and apply a thin layer of the medication, gently rubbing it in.
If necessary, cover the treated area with a dressing.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure 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 or inquire about drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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 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.
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Before and after application, wash your hands thoroughly, 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, removing any dead skin, and apply a thin layer of the medication, gently rubbing it in.
If necessary, cover the treated area with a dressing.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure 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 or inquire about drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, 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.
Lifestyle & Tips
- Keep the treated area covered with the cream at all times, reapplying if it rubs off.
- Wash hands thoroughly before and after applying the cream.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on the face, especially around the eyes, due to potential for argyria (skin discoloration) with prolonged use, though rare with topical application.
- Avoid exposure to direct sunlight or tanning beds while using this medication, as it may cause photosensitivity (increased sensitivity to sun).
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). The burn wound should be covered with silver sulfadiazine cream at all times.
Condition-Specific Dosing:
burns:
Apply 1% cream to the affected area once or twice daily to a thickness of approximately 1/16 inch (1.5 mm). Reapply immediately if removed by patient activity.
Pediatric Dosing
Neonatal:
Contraindicated in premature infants and 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, similar to adult dosing, but consider systemic absorption risk.
Child:
Apply 1% cream to the affected area once or twice daily, similar to adult dosing, but with careful consideration of body surface area and potential for systemic absorption.
Adolescent:
Apply 1% cream to the affected area once or twice daily, similar to adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for systemic adverse effects.
Moderate:
Use with caution; monitor for systemic adverse effects. Consider reduced frequency or temporary discontinuation if systemic accumulation occurs.
Severe:
Use with caution; monitor for systemic adverse effects. Consider reduced frequency or temporary discontinuation if systemic accumulation occurs.
Dialysis:
Not well studied for topical application. Systemic absorption is minimal but can occur; monitor for systemic adverse effects if applied to large areas.
Hepatic Impairment:
Mild:
Use with caution; monitor for systemic adverse effects.
Moderate:
Use with caution; monitor for systemic adverse effects.
Severe:
Use with caution; monitor for systemic adverse effects.
Pharmacology
Mechanism of Action
Silver sulfadiazine acts on the bacterial cell wall and cell membrane. The silver component is thought to exert its antimicrobial effect by reacting with DNA and inhibiting bacterial growth. The sulfadiazine component, a sulfonamide, interferes with bacterial folic acid synthesis by competing with para-aminobenzoic acid (PABA), thereby inhibiting bacterial growth. This dual mechanism provides broad-spectrum antimicrobial activity against many gram-positive and gram-negative bacteria, as well as some yeasts.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1% of silver and 10% of sulfadiazine) from intact skin; absorption increases significantly with large surface area burns or damaged skin.
Tmax:
Not applicable for topical application; systemic peak concentrations of sulfadiazine can occur within 3-11 hours if significant absorption occurs.
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not applicable for topical application; systemically absorbed sulfadiazine distributes widely.
ProteinBinding:
Approximately 95-97% for sulfadiazine (if systemically absorbed).
CnssPenetration:
Limited (if systemically absorbed, can cross BBB, especially in neonates).
Elimination:
HalfLife:
Approximately 10 hours (for systemically absorbed sulfadiazine).
Clearance:
Not precisely quantified for topical use.
ExcretionRoute:
Renal (for systemically absorbed sulfadiazine).
Unchanged:
Approximately 60-80% of systemically absorbed sulfadiazine is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Rapid (upon application).
PeakEffect:
Continuous antimicrobial activity as long as cream is present.
DurationOfAction:
Up to 24 hours (with once-daily application).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 right away:
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
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 immediately:
+ 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 extremely 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 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 attention:
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.
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 right away:
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
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 immediately:
+ 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 extremely 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 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 attention:
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:
- Signs of allergic reaction: severe rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
- Signs of blood problems: fever, sore throat, unusual bleeding or bruising, extreme tiredness.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain.
- Signs of kidney problems: change in amount of urine, swelling in ankles or feet.
- Skin irritation, redness, or rash that worsens or does not improve.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the symptoms you experienced with the allergy.
A known sulfa allergy.
If you are pregnant, especially near term.
For Parents and Caregivers:
If your child is a premature baby or a newborn, do not administer this medication. It is not suitable for premature babies or newborns.
If your child is under 2 months of age, do not give them this medication. It is not recommended for infants younger than 2 months old.
Potential Interactions:
This medication may interact with other medications or health conditions. Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to ensure it is safe to take this medication.
Do not start, stop, or change the dose of any medication without consulting your doctor first. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the symptoms you experienced with the allergy.
A known sulfa allergy.
If you are pregnant, especially near term.
For Parents and Caregivers:
If your child is a premature baby or a newborn, do not administer this medication. It is not suitable for premature babies or newborns.
If your child is under 2 months of age, do not give them this medication. It is not recommended for infants younger than 2 months old.
Potential Interactions:
This medication may interact with other medications or health conditions. Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to ensure it is safe to take this medication.
Do not start, stop, or change the dose 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 make your skin more susceptible to sunburn. Take necessary precautions when spending time outdoors, and notify your doctor if you experience increased sensitivity to the sun.
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 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 make your skin more susceptible to sunburn. Take necessary precautions when spending time outdoors, and notify your doctor if you experience increased sensitivity to the sun.
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 using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- If swallowed: nausea, vomiting, diarrhea, abdominal pain, dizziness, headache, confusion, yellowing of skin/eyes, dark urine, blood disorders (e.g., low white blood cell count).
What to Do:
Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive and symptomatic. Gastric lavage may be considered if ingestion is recent. Monitor blood counts, renal and hepatic function.
Drug Interactions
Contraindicated Interactions
- Enzyme-based debriding agents (e.g., collagenase, papain, sutilains) - silver can inactivate these enzymes.
Moderate Interactions
- Cimetidine (may increase risk of leukopenia)
- Phenytoin (may increase phenytoin levels if significant systemic absorption occurs)
- Oral hypoglycemics (sulfonylureas - theoretical risk of enhanced hypoglycemic effect if significant systemic absorption occurs)
- Methotrexate (theoretical risk of increased methotrexate toxicity if significant systemic absorption occurs)
Minor Interactions
- Other topical agents (avoid concurrent application to the same area unless directed by a physician)
Monitoring
Baseline Monitoring
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 body surface areas are treated.
Renal function (BUN, creatinine)
Rationale: To assess baseline renal function, as sulfadiazine is renally excreted.
Timing: Prior to initiation, especially in patients with pre-existing renal impairment or if large body surface areas are treated.
Liver function tests (LFTs)
Rationale: To assess baseline hepatic function, as sulfadiazine is metabolized in the liver.
Timing: Prior to initiation, especially in patients with pre-existing hepatic impairment or if large body surface areas are treated.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Every 2-3 days during initial treatment, then weekly if stable, especially if applied to large areas.
Target: WBC > 4,000 cells/mm³, Neutrophils > 1,500 cells/mm³
Action Threshold: Discontinue if WBC count falls below 2,000 cells/mm³ or if significant neutropenia develops; consider temporary discontinuation or alternative therapy.
Renal function (BUN, creatinine)
Frequency: Weekly, or more frequently if signs of renal impairment develop or if large body surface areas are treated.
Target: Within normal limits
Action Threshold: Significant increase in BUN/creatinine; consider dose adjustment or discontinuation if related to drug.
Liver function tests (LFTs)
Frequency: Weekly, or more frequently if signs of hepatic impairment develop or if large body surface areas are treated.
Target: Within normal limits
Action Threshold: Significant elevation in LFTs; consider discontinuation if related to drug.
Wound appearance and signs of infection
Frequency: Daily with dressing changes.
Target: Clean, granulating wound, absence of purulence or spreading erythema.
Action Threshold: Signs of worsening infection, non-healing wound, or adverse skin reactions (e.g., rash, irritation).
Symptom Monitoring
- Fever
- Sore throat
- Unusual bleeding or bruising (signs of hematologic dyscrasias)
- Skin rash or itching (allergic reaction)
- Nausea
- Vomiting
- Diarrhea
- Yellowing of skin or eyes (jaundice, liver dysfunction)
- Decreased urine output (renal dysfunction)
Special Patient Groups
Pregnancy
Category B. Generally considered safe for topical use during pregnancy, but caution is advised, especially near term. Avoid use in late pregnancy (third trimester) due to the theoretical risk of kernicterus in the newborn from systemic absorption of sulfadiazine, as sulfonamides can displace bilirubin from albumin binding sites.
Trimester-Specific Risks:
First Trimester:
Low risk; Category B.
Second Trimester:
Low risk; Category B.
Third Trimester:
Avoid use near term (especially last month) due to theoretical risk of kernicterus in the neonate.
Lactation
L3 (Moderate risk). Sulfonamides are excreted in breast milk. Use with caution. Avoid use in mothers breastfeeding premature infants, infants with hyperbilirubinemia, or infants with G6PD deficiency due to the risk of kernicterus or hemolytic anemia.
Infant Risk:
Risk of kernicterus (especially in premature or jaundiced infants) or hemolytic anemia (in G6PD deficient infants). Monitor infant for jaundice or signs of adverse effects.
Pediatric Use
Contraindicated in premature infants and infants less than 2 months of age due to the risk of kernicterus. Use with caution in older infants and children, as systemic absorption can occur, especially with large body surface area burns, increasing the risk of sulfonamide-related adverse effects (e.g., leukopenia, kernicterus).
Geriatric Use
No specific dose adjustments are typically required. However, elderly patients may have reduced renal function, which could increase systemic exposure if significant absorption occurs. Monitor for systemic adverse effects, particularly hematologic and renal, with caution.
Clinical Information
Clinical Pearls
- Silver sulfadiazine is primarily used for second and third-degree burns to prevent and treat wound infections.
- It should be applied to a clean, debrided wound surface.
- The cream should be applied thinly (approx. 1/16 inch or 1.5 mm) and kept on the wound at all times.
- Leukopenia (low white blood cell count) is a common side effect, usually transient and reversible upon discontinuation. Regular CBC monitoring is crucial, especially during the initial phase of treatment.
- Avoid concurrent use with enzymatic debriding agents, as silver can inactivate them.
- While systemic absorption is minimal, it can occur, leading to sulfonamide-related side effects (e.g., rash, renal impairment, blood dyscrasias), especially with large surface area burns or prolonged use.
- Photosensitivity can occur; advise patients to avoid excessive sun exposure.
Alternative Therapies
- Mafenide acetate (Sulfamylon) cream/solution (another topical antimicrobial for burns, penetrates eschar better but can cause metabolic acidosis)
- Bacitracin/Polymyxin B topical (for superficial burns or minor wounds)
- Povidone-iodine topical (antiseptic, broad-spectrum)
- Honey-based dressings (for wound healing and antimicrobial properties)
- Topical antibiotics (e.g., mupirocin, neomycin/polymyxin B/bacitracin for minor wounds, not typically for extensive burns)
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $200+ per 1000gm jar
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic), Tier 3 (Brand)
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 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 for more information. 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 details about the medication taken, the amount, and the time it occurred.