Get your patient on Ssd Cream - Silver Sulfadiazine cream (Silver Sulfadiazine)

Silver Sulfadiazine Cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.

Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain.  The burn wounds are then cleansed and debrided; Silver Sulfadiazine Cream is then applied under sterile conditions.  The burn areas should be covered with Silver Sulfadiazine Cream at all times.  The cream should be applied once to twice daily to a thickness of approximately one sixteenth of an inch.  Whenever necessary, the cream should be reapplied to any areas from which it has been removed due to patient activity.  Administration may be accomplished in minimal time because dressings are not required.  However, if individual patient requirements make dressings necessary, they may be used.  Reapply immediately after hydrotherapy.  Treatment with Silver Sulfadiazine Cream should be continued until satisfactory healing has occurred or until the burn site is ready for grafting.  The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

Silver Sulfadiazine Cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation.

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.

Several cases of transient leucopenia have been reported in patients receiving silver sulfadiazine therapy.  Leucopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count.  Maximal white blood cell depression occurs within two to four days of initiation of therapy.  Rebound to normal leukocyte levels follows onset within two to three days.  Recovery is not influenced by continuation of silver sulfadiazine therapy.  The incidence of leucopenia in various reports averages about 20%.  A higher incidence has been seen in patients treated concurrently with cimetidine.

Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis.  Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial thickness burns by preventing conversion of the partial thickness to full thickness by sepsis.  However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage.  Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur.  Some of the reactions which have been associated with sulfonamides are as follows: blood dyscrasias, agranulocytosis, aplastic anemia, thrombocytopenia, leucopenia, hemolytic anemia, dermatologic reactions, allergic reactions, Stevens-Johnson syndrome, exfoliative dermatitis, gastrointestinal reactions, hepatitis, hepatocellular necrosis, CNS reactions, and toxic nephrosis.

SSD™ (1% Silver Sulfadiazine Cream) and SSD AF™ (1% Silver Sulfadiazine Cream), 1% are topical antibacterial preparations which have as their active antimicrobial ingredient silver sulfadiazine. The active moiety is contained within an opaque, white, water miscible cream base.

Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver sulfadiazine.

Inactive Ingrediants: cetyl alcohol (SSD Cream only), isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methyl paraben, as a preservative.

Silver sulfadiazine has an emprical formula of C ₁₀ H ₉ AgN ₄ O ₂ S, molecular weight of 357.14 and structural formula as shown:

Silver sulfadiazine has broad antimicrobial activity.  It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast.  Results from in vitro testing are listed below.  Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine.  Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine.  Silver sulfadiazine acts only on the cell wall to produce its bactericidal effect.

Results of In Vitro Testing With Silver Sulfadiazine Cream, 1% Concentration of Silver Sulfadiazine
Number of Sensitive Strains / Total Number of Strains Tested

Genus and Species                  50 micrograms/mL      100 micrograms/mL

Pseudomonas Aeruginosa            130/130                     130/130

Xanthomonas (Pseudomonas)

Maltophilia                                 7/7                             7/7

Enterobacter Species                   48/50                          50/50

Enterobacter cloacae                   24/24                          24/24

Klebsiella Species                       53/54                          54/54

Escherichia Coli                          63/63                          63/63

Serratia Species                         27/28                          28/28

Proteus Mirabilis                        53/53                           53/53

Morganella Morganii                   10/10                           10/10

Providencia Rettgeri                    2/2                              2/2

Proteus Vulgaris                         2/2                               2/2

Providencia Species                    1/1                              1/1

Citrobacter Species                   10/10                          10/10

Acinetobacter Calcoaceticus      10/11                          11/11

Stahylococcus Aureus             100/101                       101/101

Staphylococcus Epidermidis      51/51                           51/51

B-Hemolytic Streptococcus         4/4                              4/4

Enterococcus Species              52/53                          53/53

Corynebacterium Diphtheriae       2/2                               2/2

Clostridium Perfringens               0/2                               2/2

Clostridium Perfringens               0/2                               2/2

Candida Albicans                    43/50                             50/50

Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

SSD™ (1% Silver Sulfadiazine) Cream : white to off-white cream.

50 gram jar                     NDC 43598-210-55

400 gram jar                     NDC 43598-210-40

25 gram tube                     NDC 43598-210-25

50 gram tube                     NDC 43598-210-50

85 gram tube                     NDC 43598-210-85

SSD AF™ (1% Silver Sulfadiazine) Cream : white to off-white cream.

50 gram jar                     NDC 43598-211-55

400 gram jar                      NDC 43598-211-40

Store at controlled room temperature 15° - 30°C (59° - 86°F)

SSD is a trademark of Dr. Reddy's Laboratories, Inc.

Manufactured by:
Dr. Reddy's Laboratories Louisiana LLC
Shreveport, LA 71106 USA

Revised, June 2013