DailyMed Label: SSD Cream

DailyMed Label: SSD Cream

2024

DailyMed Prescription

SSD Cream

Silver Sulfadiazine

Lake Erie Medical DBA Quality Care Products LLC

NDC: 55700-640

NDC: 55700-640

NDC: 55700-640

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: Structure for 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  The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.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.

If hepatic and renal functions become impaired and elimination of the drug decreases accumulation may occur and discontinuation of Silver Sulfadiazine Cream should be weighed against the therapeutic benefit being achieved. In considering the use of topical proteolytic enzymes in conjunction with Silver Sulfadiazine Cream, the possibility should be noted that silver may inactivate such enzymes. Laboratory Tests: In the treatment of burn wounds involving extensive areas of the body, the serum sulfa concentrations may approach adult therapeutic levels (8 to 12mg %).  Therefore, in these patients it would be advisable to monitor serum sulfa concentrations.  Renal function should be carefully monitored and the urine should be checked for sulfa crystals.  Absorption of the propylene glycol vehicle has been reported to affect serum osmolality, which may affect the interpretation of laboratory tests.

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.

SSD™ (1% Silver Sulfadiazine) Cream : white to off-white cream. SSD AF™ (1% Silver Sulfadiazine) Cream : white to off-white cream. 50 gram jar                     NDC 55700-640-50 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

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.

image description