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Silver Sulfadiazine

Pronunciation

(SIL ver sul fa DYE a zeen)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Silvadene: 1% (20 g, 25 g, 50 g, 85 g, 400 g, 1000 g) [contains methylparaben, propylene glycol]

SSD: 1% (25 g, 50 g, 85 g, 400 g) [contains cetyl alcohol, methylparaben, propylene glycol]

Thermazene: 1% (20 g [DSC], 50 g [DSC], 85 g [DSC], 400 g [DSC], 1000 g [DSC]) [contains methylparaben, propylene glycol]

Generic: 1% (20 g, 25 g, 50 g, 85 g, 400 g)

Brand Names: U.S.

  • Silvadene
  • SSD
  • Thermazene [DSC]

Pharmacologic Category

  • Antibiotic, Topical

Pharmacology

Acts upon the bacterial cell wall and cell membrane. Bactericidal for many gram-negative and gram-positive bacteria and is effective against yeast. Active against 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

Absorption

Significant percutaneous absorption of silver sulfadiazine can occur especially when applied to extensive burns

Excretion

Urine (~50% as unchanged drug)

Time to Peak

Serum: 3-11 days of continuous therapy

Half-Life Elimination

10 hours; prolonged with renal impairment

Use: Labeled Indications

Prevention and treatment of infection in second and third degree burns

Contraindications

Hypersensitivity to silver sulfadiazine or any component of the formulation; premature infants or neonates <2 months of age (sulfonamides may displace bilirubin and cause kernicterus); pregnancy (approaching or at term)

Dosage

Children and Adults: Topical: Apply once or twice daily with a sterile-gloved hand; apply to a thickness of 1/16”; burned area should be covered with cream at all times

Administration

Apply with a sterile-gloved hand. Apply to a thickness 1/16”. Burned area should be covered with cream at all times.

Storage

Discard if cream is darkened (reacts with heavy metals resulting in release of silver).

Drug Interactions

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Adverse Reactions

Frequency not defined.

Dermatologic: Discoloration of skin, erythema multiforme, itching, photosensitivity, rash

Hematologic: Agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia

Hepatic: Hepatitis

Renal: Interstitial nephritis

Miscellaneous: Allergic reactions may be related to sulfa component

Warnings/Precautions

Concerns related to adverse effects:

• Sulfonamide allergy: Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling, however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

• Systemic effects: Systemic absorption may be significant and adverse reactions may occur.

DIsease-related concerns:

• G6PD deficiency: Use with caution in patients with G6PD deficiency; hemolysis may occur.

• Hepatic impairment: Use with caution in patients with hepatic impairment; sulfadiazine may accumulate.

• Renal impairment: Use with caution in patients with renal impairment; sulfadiazine may accumulate.

Concurrent drug therapy issues:

• Analgesics: Use of an analgesic might be needed before application.

Monitoring Parameters

Serum electrolytes, urinalysis, renal function tests, CBC in patients with extensive burns on long-term treatment

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Because of the theoretical increased risk for hyperbilirubinemia and kernicterus, sulfadiazine is contraindicated for use near term, on premature infants, or on newborn infants during the first 2 months of life (refer to Sulfadiazine monograph).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience skin discoloration. Have patient report immediately to prescriber signs of infection, signs of hepatic impairment, hematuria, urinary retention, ecchymosis, hemorrhaging, considerable asthenia, significant dyspepsia, severe skin irritation, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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