silver sulfadiazine

Silver sulfadiazine is a broad spectrum antimicrobial medication topically applied on burn wounds to prevent infection.

Burn sepsis is the major cause of death in patients with extensive burns and prevention of infection is vital. Silver sulfadiazine is effective against gram-positive and gram-negative bacteria, which are structurally different, and some species of yeast.

Although silver sulfadiazine is a sulfa-derived drug, unlike other sulfonamide drugs, it does not inhibit the synthesis of folic acid that microbes require to survive and grow. The silver ions in silver sulfadiazine act on both bacterial cell wall and the additional membrane that gram-negative bacteria have. Silver ions make the microbial cell wall and membrane more permeable, leading to leakage of cell contents and cell death.

Organisms susceptible to silver sulfadiazine include:

Pseudomonas aeruginosa, Pseudomonas maltophilia, Enterobacter species, Klebsiella species, Serratia species, Escherichia coli, Proteus mirabilis, Morganella morganii, Providencia rettgeri, Proteus vulgaris, Providencia species, Citrobacter species, Acinetobacter calcoaceticus, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus species, Candida albicans, Corynebacterium diphtheriae, and Clostridium perfringens.

• Do not use silver sulfadiazine to treat patients who are:
  • Hypersensitive to sulfa drugs, silver sulfadiazine or any of its components
  • Near term or at term pregnant women
  • Infants below 2 months of age
• Use with caution in patients with glucose-6-phosphate-dehydrogenase (G6PD) deficiency, an inherited disorder that causes red blood cell destruction (hemolysis). Silver sulfadiazine may exacerbate the condition. 
• Prolonged use may result in bacterial or fungal superinfections.
• Although silver sulfadiazine is minimally absorbed, it reacts with body fluids to release sulfadiazine, which is absorbed in varying amounts depending on the extent of tissue damage and percentage of body surface it is applied on. Adverse reactions may include severe skin reactions, central nervous system (CNS) reactions, liver injury and kidney damage.
• Use silver sulfadiazine with caution in patients with kidney or liver function impairment.
• Many formulations contain propylene glycol which can be toxic in large amounts.

Common side effects of silver sulfadiazine include:

• Skin reactions that include:
  • Rash
  • Itching
  • Pain
  • Burning
  • Skin discoloration
  • Photosensitivity
  • Red, raised lesions (erythema multiforme)
• Severe skin reactions such as:
  • Skin tissue death (necrosis)
  • Stevens-Johnson syndrome
  • Toxic epidermal necrosis
  • Exfoliative dermatitis
• Liver inflammation (hepatitis)
• Hepatocellular necrosis
• Inflammation in the kidney (interstitial nephritis)
• Kidney damage from the drug (toxic nephrosis)
• Adverse gastrointestinal effects
• Adverse central nervous system effects
• Blood disorders including:
  • Low red blood cell count due to reduced production (aplastic anemia)
  • Low red blood cell count due to rapid destruction (hemolytic anemia) in patients with G6PD deficiency
  • Low count of granulocyte immune cells (agranulocytosis)
  • Low level of leukocyte immune cells (leukopenia)
  • Low platelet levels (thrombocytopenia)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Cream

• 1%

Adult:

Burn wound infections (2nd degree/3rd degree)

1% cream: Apply every 12-24 hours to burn

Dosing Considerations

• Reapply as necessary; burn should be covered with cream at all times; continue use until healed or the burn site is ready for grafting; continue therapy if the possibility of infection exists unless a significant adverse reaction has occurred

Dosing Modifications

• Renal impairment: Use with caution; drug accumulation is possible
• Hepatic impairment: Use with caution; drug accumulation is possible

Pediatric:

Burn wound infections (2nd degree/3rd degree)

• Infants under 2 months: contraindicated
• Infants over 2 months (1% cream): Apply every 12-24 hours to burn

• Silver sulfadiazine overdose is uncommon, however, systemic absorption can be significant if applied on large surfaces of the skin, mucous membranes, or near the eyes.
• Many silver sulfadiazine formulations contain propylene glycol which can be potentially toxic in large amounts and has been related with high blood levels of lactic acid (lactic acidosis), high concentration of chemicals in blood (hyperosmolality), seizures, and respiratory depression.
• Overdose may be treated with symptomatic and supportive care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Silver sulfadiazine has no known severe interactions with other drugs.
• Serious interactions of silver sulfadiazine include:
  • allogeneic cultured keratinocytes and fibroblasts
• Moderate and mild interactions of silver sulfadiazine include:
  • collagenase
  • papain
  • trypsin

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Silver sulfadiazine may be used with caution during pregnancy if maternal benefits justify potential fetal risks and the burn area covers more than 20% of the body surface.
• Silver sulfadiazine should not be used in near or at term pregnancy, on premature infants or on newborns up to 2 months of age, because of the risk for high bilirubin levels (hyperbilirubinemia) and associated brain damage (kernicterus) in the infant.
• It is not known if silver sulfadiazine is present in milk. Avoid use in breastfeeding women, because of the potential of serious adverse reactions in the breastfed infant. Decision should be made to discontinue nursing or the medication, depending on the mother’s clinical need.

• Silver sulfadiazine is only for topical use. Apply exactly as prescribed.
• Avoid contact with eyes.
• Store safely out of reach of children.
• In case of overdose from systemic absorption after topical application or accidental ingestion, seek medical help or contact Poison Control.