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Topical antimicrobial / Burn wound dressing Pregnancy: US label (no separate pregnancy section was retrieved; the statement is in CONTRAINDICATIONS): 'Because sulfonamide therapy is known to increase the possibility of kernicterus, Silver Sulfadiazine Cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.' No other pregnancy or lactation statement is present in the retrieved sections.

Silver Sulfadiazine 1% Cream

Brand names: Flamazine

Silver sulfadiazine is a topical antibacterial cream used to prevent and treat infection in burns and certain chronic wounds and leg ulcers.

Adult dose

Dose: Adjunct for the prevention and treatment of wound sepsis in second- and third-degree burns (silver sulfadiazine 1% cream): apply once to twice daily to a thickness of approximately one sixteenth of an inch.
Route: Topical, to the burn wound, applied under sterile conditions after the wound has been cleansed and debrided. For topical use only - not for ophthalmic use.
Frequency: Once to twice daily. Reapply to any area from which the cream has been removed by patient activity, and reapply immediately after hydrotherapy. Continue until satisfactory healing has occurred or the burn site is ready for grafting.
US label (SSD Cream, 1% silver sulfadiazine). The burn areas should be covered with the cream at all times. Dressings are not required, but may be used if individual patient requirements make them necessary. The drug should not be withdrawn from the regimen while there remains the possibility of infection, except if a significant adverse reaction occurs. The label gives no maximum amount, no age-specific regimen and no dressing-change interval. The label states control of shock and pain is of prime importance and that the burn wounds are first cleansed and debrided. Extensive burns: serum sulfa concentrations may approach adult therapeutic levels (8 to 12mg %), so monitoring is advisable. Not for use on pregnant women approaching or at term, premature infants, or newborn infants during the first 2 months of life (kernicterus risk). No UK SPC for silver sulfadiazine is listed on eMC — this dose is from US prescribing information (SSD Cream, Preferred Pharmaceuticals Inc.) and must be verified against UK practice.

Dose adjustments

Renal

No dose figure is given. US label PRECAUTION: if hepatic and renal functions become impaired and elimination of the drug decreases, accumulation may occur, and discontinuation should be weighed against the therapeutic benefit being achieved. In extensive burns, renal function should be carefully monitored and the urine checked for sulfa crystals.

Hepatic

No dose figure is given. US label PRECAUTION: if hepatic and renal functions become impaired and elimination of the drug decreases, accumulation may occur, and discontinuation should be weighed against the therapeutic benefit being achieved.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to silver sulfadiazine or any of the other ingredients in the preparation
  • Pregnant women approaching or at term - sulfonamide therapy is known to increase the possibility of kernicterus
  • Premature infants
  • Newborn infants during the first 2 months of life

Side effects

  • Transient leucopenia, primarily decreased neutrophil count - incidence in various reports averages about 20%; maximal white blood cell depression occurs within two to four days of starting, with rebound to normal two to three days after onset; higher incidence in patients treated concurrently with cimetidine
  • Infrequent: skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, interstitial nephritis
  • Fungal proliferation in and below the eschar may occur (incidence of clinically reported fungal superinfection is low)
  • Reduction in bacterial colonisation has caused delayed separation of eschar, in some cases necessitating escharotomy to prevent contracture
  • Absorption varies with the percent of body surface area and extent of tissue damage; any adverse reaction associated with sulfonamides may occur, including blood dyscrasias, agranulocytosis, aplastic anaemia, thrombocytopenia, haemolytic anaemia, Stevens-Johnson syndrome, exfoliative dermatitis, hepatitis, hepatocellular necrosis and toxic nephrosis

Interactions

  • Cimetidine - higher incidence of leucopenia in patients treated concurrently
  • Topical proteolytic enzymes - silver may inactivate such enzymes
  • Potential cross-sensitivity with other sulfonamides - if allergic reactions attributable to silver sulfadiazine occur, weigh continuation against the hazards of the particular allergic reaction

Monitoring

  • Extensive burns: monitor serum sulfa concentrations - these may approach adult therapeutic levels (8 to 12mg %)
  • Extensive burns: monitor renal function carefully and check the urine for sulfa crystals
  • Glucose-6-phosphate dehydrogenase-deficient individuals: use may be hazardous as haemolysis may occur
  • Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests
  • Fungal proliferation in and below the eschar, and delayed eschar separation

Clinical monograph

How it works

It releases silver ions that act on the bacterial cell wall and membrane, combined with the sulphonamide component, giving broad-spectrum antibacterial activity against organisms including Pseudomonas.

Prescribing in practice

  • Contraindicated in patients with sulphonamide hypersensitivity and avoided in pregnancy near term, in neonates and in infants because of the risk of kernicterus.
  • Use over large areas may lead to systemic sulphonamide absorption and, rarely, leucopenia or argyria with prolonged use.
  • May interact with topical proteolytic (enzymatic) debriding agents, reducing their activity.

Monitoring

For extensive or prolonged application, monitor full blood count and watch for signs of systemic absorption and hypersensitivity.

Counselling the patient

  • A transient grey or black skin discolouration may occur at the application site.
  • Report rash, fever or other signs of an allergic reaction.
  • The cream may stain clothing and bedding.

Evidence & guidelines

Silver sulfadiazine is an established topical antimicrobial for burns, supported by long-standing clinical use, though evidence for improved healing over modern dressings is limited.

Reference: BAD Burns Guidelines; BBA Burns Assessment Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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