Silver Sulfadiazine

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications: 

• Prevention and treatment of bacterial and fungal infections

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other sulfonamides
• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Porphyria
• Premature infants or infants in the first months of life

Cautions 

• Elderly
• Application to large areas
• Application to deep lesions
• Systemic lupus erythematosus
• Acquired immune-deficiency syndrome
• Glucose-6-phosphate dehydrogenase deficiency

Forms avail. in SA and covered in this monograph: cre

Dosages below include:

• South African registered indications and dosages

Infections caused by: 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 and yeast 

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African registered indications and dosages

Prevention and treatment of bacterial and fungal infections
- To reduce microbial colonisation and the incidence of infections in wounds (such as leg ulcers, pressure sores or fingertip injuries) and burns (such as hand burns)

• Topical (cre): Apply 3-5mm thick over the affected area(s), dly

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Apply with a sterile gloved hand or a spatula to a cleaned wound. The wound may be dressed or left open after application

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If treating a burn, re-apply at least every 24hrs or more frequently if the volume of debris is large

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One container of silver sulfadiazine should be reserved for one patient and any remaining cream should be discarded after treatment

Paed. forms avail. in SA and covered in this monograph: cre

Paed. dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages

Infections caused by: 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 and yeast 

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Burns >20% body surface area

• Topical (cre): Apply small amount to affected area(s), dly on non-adhesive dressings
  (STG, Paed. 2017)

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South African registered indications and dosages

Prevention and treatment of bacterial and fungal infections
- To reduce microbial colonisation and the incidence of infections in wounds (such as leg ulcers, pressure sores or fingertip injuries) and burns (such as hand burns)

• See adult dosage

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Sulfonamide therapy is known to increase the possibility of kernicterus; therefore silver sulfadiazine cream should not be used in premature infants or infants during the first months of life

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No specific recommendations for paediatric dosages are provided in South African manufacturer recommendations

Pregnancy

• Contraindicated
• Sulfonamide therapy is known to increase the possibility of kernicterus; therefore silver sulfadiazine cream should not be used in pregnancy 
• Silver sulfadiazine should not be used if pregnant or planning to become pregnant 

Breastfeeding

• Contraindicated
• Silver sulfadiazine should not be used during breastfeeding 

Renal Impairment

• Contraindicated 

Hepatic Impairment

• Contraindicated 

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Aseptic meningitis
• Ataxia
• Benign intracranial hypertension
• Seizures
• Dizziness
• Drowsiness
• Fatigue  
• Headache
• Insomnia
• Depression
• Peripheral neuropathy
• Psychosis

Cardiovascular Disorders

• Vasculitis
  - Polyarteritis nodosa
• Myocarditis

Respiratory Disorders

• Fibrosing alveolitis
• Pulmonary eosinophilia
• Difficulty breathing

Gastrointestinal Disorders

• Nausea and vomiting
• Anorexia
• Diarrhoea

Hepatobiliary Disorders

• Hepatic necrosis
• Jaundice
• Hepatomegaly
• Pancreatitis
• Serum bound bilirubin displacement
• Kernicterus

Genitourinary Disorders

• Interstitial nephritis
• Acute tubular necrosis
• Haematuria
• Oliguria
• Anuria
• Crystallisation in the urine
• Renal failure

Endocrine and Metabolic Disorders

• Hypoglycaemia
• Hypothyroidism

Musculoskeletal Disorders

• Lumbar pain

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Application site rash
  - Eczema
  - Contact dermatitis
• Argyria
• Pain at application site
• Redness at application site
• Burning at application site
• Rash
• Itchiness
• Photosensitive reactions
• Dermatitis
  - Exfoliative dermatitis
• Toxic epidermal necrolysis (Lyell's Syndrome)
• Erythema nodosum
• Stevens-Johnson syndrome
• Systemic lupus erythematosus
  - Exacerbations of previous systemic lupus erythematosus
• Delayed separation of the eschar
• Cyanosis

Immune, Blood and Lymphatic System Disorders

• Leucopaenia
• Agranulocytosis
• Aplastic anaemia
• Thrombocytopenia
• Hypoprothrombinaemia
• Eosinophilia
• Fungal infection of the wound
• Methaemoglobinaemia
• Anaphylaxis
• Fever
• Serum sickness

Sensory Disorders

• Optic neuropathy
• Vertigo

• Oral anticoagulants
• Methotrexate
• Phenytoin
• Oral hypoglycaemic agents

Other interactions

• Diagnostic tests
  - Urea
  - Creatinine
  - Urinary glucose
  - Urobilinogen

None routine. Specific cases may require

• Full blood count
• Serum electrolytes
• Urinalysis
• Renal function tests
• Serum sulfa concentrations

Administration directions

- Hand burns

• Silver sulfadiazine cream can be applied to the burn and the whole hand enclosed in a clear plastic bag or glove which is then closed at the wrist
• The patient should be encouraged to move the hand and fingers
• The dressing should be changed when an excessive amount of exudate has accumulated in the bag

- Leg ulcers/Pressure sores

• As silver sulfadiazine can cause maceration of normal skin on prolonged contact care should be taken to prevent spread onto non-ulcerated areas
• Application of silver sulfadiazine cream should be followed by an absorbent pad or gauze dressing with further application of pressure bandaging as appropriate for the ulcer
• The dressings should normally be changed daily but for wounds which are less exudative, less frequent changes (every 48hrs) may be acceptable
• Cleansing and debriding should be performed before application of silver sulfadiazine cream
• Silver sulfadiazine cream is not recommended for use in leg or pressure ulcers that are very exudative

Silver sulfadiazine, a sulfonamide antibacterial, acts on the bacterial cell wall and cell membrane of susceptible organisms.

Spectrum of activity: 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 and yeast 

Cream (per g) 10mg

• Bactrazine (Smith & Nephew)
• Flamazine (Smith & Nephew) originator
• Silbecor (Biotech)