Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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; Container Label for 25 g Tube SSD™ NDC 43598-210-25 Dr. Reddy’s 25 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%; Container Label for 50 g Tube SSD™ NDC 43598-210-50 Dr. Reddy’s 50 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%; Container Label for 85 g Tube SSD™ NDC 43598-210-85 Dr. Reddy’s 85 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%; Container Label for 50 g Jar SSD™ NDC 43598-210-55 Dr. Reddy’s 85 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%; Container Label for 400 g Jar SSD™ NDC 43598-210-40 Dr. Reddy’s 85 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%
- HOW SUPPLIED 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
- Container Label for 25 g Tube SSD™ NDC 43598-210-25 Dr. Reddy’s 25 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%
- Container Label for 50 g Tube SSD™ NDC 43598-210-50 Dr. Reddy’s 50 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%
- Container Label for 85 g Tube SSD™ NDC 43598-210-85 Dr. Reddy’s 85 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%
- Container Label for 50 g Jar SSD™ NDC 43598-210-55 Dr. Reddy’s 85 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%
- Container Label for 400 g Jar SSD™ NDC 43598-210-40 Dr. Reddy’s 85 Grams 1% Silver Sulfadiazine Cream 1% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only Silver Sulfadiazine…10mg/g in a hydrophilic base consisting of cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, purified water, stearyl alcohol, sodium hydroxide, sorbitan monooleate, white petrolatum; with 0.3% methylparaben, as a preservative. See full prescribing information for dosage and administration. Store at controlled room 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 Silver Sulfadiazine 1%
Overview
DESCRPITION 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
Indications & 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.
Dosage & 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.
Warnings & Precautions
WARNING 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.
Contraindications
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.
Adverse Reactions
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.
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