SSD (Sulfadiazine Topical)

SSD™ Knoll Silver Sulfadiazine Topical Antibacterial

Action and Clinical

The mechanism of silver sulfadiazine’s antimicrobial action has not been fully elucidated. The dominant manifestation of the reaction of silver sulfadiazine with sensitive organisms may result from the displacement of hydrogen bonds within the bacterial DNA. Once these bonds that serve to connect the 2 strands of the DNA double helix are displaced, bacterial replication and cell viability are effectively reduced.

Mammalian cells have approximately 100 times more DNA than bacterial cells. Thus, the ratio of inhibitory concentrations of silver sulfadiazine to bacterial DNA is high enough to prevent bacterial division. However, the resulting ratio of silver sulfadiazine to epithelial DNA is sufficiently low that epithelial cell regeneration is not impaired.

Indications And Clinical Uses:

For the adjunctive treatment of burns, skin grafts, incisions, leg ulcers and other clean lesions, abrasions, minor cuts and wounds. It is especially indicated in the treatment and prophylaxis of infection in serious burn victims.

Contra-Indications:

In patients with a history of hypersensitivity to silver sulfadiazine.:

Since sulfonamide derivatives are known to increase the possibility of kernicterus, silver sulfadiazine cream should not be used in pregnant women approaching or at term, in premature infants, or in neonates less than 2 months of age.

Warnings in Clinical States:

Silver sulfadiazine cream should be administered with caution to patients with a history of hypersensitivity to silver sulfadiazine. It is not known whether prior sensitivity to other sulfonamides will precipitate an allergic response to silver sulfadiazine cream.

Silver sulfadiazine cream should be used with caution in patients with a history of G-6-PD deficiency, as hemolysis may occur.

When treatment with silver sulfadiazine cream involves prolonged administration and/or large burn surfaces, considerable amounts of silver sulfadiazine are absorbed. Serum concentrations of sulfadiazine may approach adult therapeutic levels (8 to 12 mg %).

Precautions:

Following administration of silver sulfadiazine cream, absorption of sulfadiazine has been reported. In addition, small amounts of silver are absorbed over the course of repeated application of silver sulfadiazine cream. In extensively burned patients, serum sulfa concentrations and renal functions should be closely monitored.

Silver sulfadiazine cream should be used with caution in patients with significant hepatic or renal impairment.

Leukopenia has been reported following the use of silver sulfadiazine cream, especially in patients with large burn areas (see Adverse Effects).

Drug Interactions:

Enzymatic Debridement: Silver sulfadiazine cream may inactivate topical enzymatic preparations used for debridement. Therefore, the use of concomitant systemic or alternative topical antimicrobial therapy should be considered.

Oral Hypoglycemic Agents and Phenytoin: Sulfa drugs may compete for the same degradation pathways utilized by some oral hypoglycemic agents and phenytoin. There is a possibility of half-life prolongation and decreased plasma clearance of these drugs, which may potentiate their activity.

Cimetidine: An increased incidence of leukopenia has been observed in patients receiving concomitant treatment with silver sulfadiazine cream and cimetidine.

Pregnancy: The safe use of silver sulfadiazine cream has not been established in pregnancy. The cream should be administered to pregnant women only when the physician decides that the potentially life-saving benefits of silver sulfadiazine therapy in the larger burn (extent greater than 20% body surface area) outweigh possible hazard to the fetus (see Contraindications).

Adverse Reactions:

:Leukopenia: Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. Leukopenia associated with silver sulfadiazine administration is primarily characterized by a decreased neutrophil count. Maximal white blood cell depression occurs within 2 to 4 days of initiation of therapy. Rebound to normal leukocyte levels follow onset of leukopenia within 2 to 3 days. Recovery is not influenced by continuation of silver sulfadiazine therapy. The incidence of leukopenia in various reports averages about 20% although an incidence as high as 55% has been noted.

Sulfonamides: During the treatment of burns over large body surfaces (greater than 20% body surface area), significant amounts of silver sulfadiazine are systemically absorbed. Therefore, it is possible that any adverse reactions associated with sulfonamides may occur.

Miscellaneous: A low incidence of other adverse reactions has been reported. This includes local burning sensation, rashes and pruritus, and rarely, interstitial nephritis

Symptoms And Treatment Of Overdose:

In extensively burned patients or in patients suspected of showing symptoms of excessive absorption, it is important to optimally maintain fluid balance to prevent dehydration and the associated possibility of renal impairment.

Dosage And Administration:

The cream should be applied to a thickness of at least 3 to 5 mm to burned surfaces once or twice daily. It is recommended that a protocol for management of the burn wound using accepted principles and techniques of debridement be followed. Silver sulfadiazine cream should be applied with sterile gloves. Silver sulfadiazine cream will provide antimicrobial activity when used with either open treatment or an occlusive dressing regimen. When treating patients using the open method, care must be taken to promptly reapply silver sulfadiazine cream whenever it is removed by patient movement.

The cream application should continue until either spontaneous healing or grafting of the burn wound is achieved.

Availability And Storage:

Each g of nonsterile cream contains: micronized silver sulfadiazine 1%. Nonmedicinal ingredients: isopropyl myristate, methylparaben, polyoxyl 40 stearate, propylene glycol, purified water, sodium hydroxide, sorbitan monooleate, stearyl alcohol and white petrolatum. Jars of 50 and 400 g. Store between 15 and 30°C.

SSD™ Knoll Silver Sulfadiazine Topical Antibacterial