DESCRIPTION

SSD (1% Silver Sulfadiazine) Cream and SSD AF (1% Silver Sulfadiazine) Cream 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 Ingredients: 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 C10H9AgN4O2S, molecular weight of 357.14 and structural formula as shown:

CLINICAL PHARMACOLOGY

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.

Silver 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.

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.

WARNINGS

There is 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.

PRECAUTIONS

General: If hepatic and renal functions become impaired and elimination of 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.

ADVERSE REACTIONS

Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. Leukopenia 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 leukopenia 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, including agranulocytosis, aplastic anemia, thrombocytopenia, leucopenia and hemolytic anemia, dermatologic and and allergic reactions, including Stevens-Johnson syndrome and exfoliative dermatitis, gastrointestinal reactions, hepatitis and hepatocellular necrosis, CNS reactions, and toxic nephrosis.

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

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

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

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

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

Manufactured for

Par Pharmaceutical Companies, Inc.

Spring Valley, NY 10977

Manufactured by

Dr. Reddy's Laboratories Louisiana, LLC

Shreveport, LA 71106

Rev. 05/10

PRINCIPAL DISPLAY PANEL – 50 GRAM TUBE

PRINCIPAL DISPLAY PANEL – 400 GRAM JAR

PRINCIPAL DISPLAY JAR PANEL - AF 400 GRAM JAR