The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
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.
sulfadiazine has an emprical formula of
2S, 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
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.
In Vitro Testing With
Silver Sulfadiazine Cream, 1% Concentration of Silver Sulfadiazine
Sensitive Strains / Total Number of Strains Tested
Genus and Species 50 micrograms/mL 100
micrograms/mLPseudomonas Aeruginosa 130/130 130/130Xanthomonas (Pseudomonas) Maltophilia 7/7
7/7Enterobacter Species 48/50
50/50Enterobacter cloacae 24/24
24/24Klebsiella Species 53/54
54/54Escherichia Coli 63/63
63/63Serratia Species 27/28
28/28Proteus Mirabilis 53/53
53/53Morganella Morganii 10/10
10/10Providencia Rettgeri 2/2
2/2Proteus Vulgaris 2/2
2/2Providencia Species 1/1
1/1Citrobacter Species 10/10
10/10Acinetobacter Calcoaceticus 10/11 11/11Stahylococcus Aureus 100/101 101/101Staphylococcus Epidermidis 51/51 51/51B-Hemolytic Streptococcus 4/4 4/4Enterococcus Species 52/53 53/53Corynebacterium Diphtheriae 2/2 2/2Clostridium Perfringens 0/2
2/2Clostridium Perfringens 0/2
2/2Candida Albicans 43/50
50/50Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be
useful in situations where such agents are contraindicated.
Indications And Usage
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.
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.
There is a potential cross-sensitivity between silver sulfadiazine and
other sulfonamides. If allergic reactions attributable to treatment with
silver sulfadiazine occur, continuation of therapy must be weighed against the
potential hazards of the particular allergic reaction. Fungal proliferation in and below the eschar may occur. However, the
incidence of clinically reported fungal superinfection is low.The use of Silver Sulfadiazine Cream in some cases of
glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as
hemolysis may occur.
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.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term dermal toxicity studies of 24 months duration in rats and 18
months in mice with concentrations of silver sulfadiazine three to ten times
the concentration in Silver Sulfadiazine Cream revealed no evidence of
carcinogenicity.Pregnancy: Pregnancy Category B. A
reproductive study has been performed in rabbits at doses up to three to ten
times the concentration of silver sulfadiazine in Silver Sulfadiazine Cream and
has revealed no evidence of harm to the fetus due to silver sulfadiazine.
There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human
response, this drug should be used during pregnancy only if clearly justified,
especially in pregnant women approaching or at term. (See
Nursing Mother: It is not known
whether Silver Sulfadiazine Cream is excreted in human milk. However,
sulfonamides are known to be excreted in human milk and all sulfonamides
derivatives are known to increase the possibility of kernicterus. Because of
the potential for serious adverse reactions in nursing infants from
sulfonamides, a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to the
Pediatric Use: Safety and
effectiveness in children have not been established. (See
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.
Dosage And Administration: For Topical Use Only - Not For Ophthalmic Use:
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.
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.
Dr. Reddy's Laboratories Louisiana LLC
Shreveport, LA 71106 USA
Revised, June 2013
* Please review the disclaimer below.