FDA Section 5 \u2022 cited verbatim

Sulfadiazine - Warnings and Precautions

The following warnings and precautions are taken directly from the US FDA-approved drug label for Sulfadiazine. This is the same information dispensing pharmacists read.

WARNINGS 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, leukopenia, and hemolytic anemia; dermatologic and allergic reactions, including life-threatening cutaneous reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and exfoliative dermatitis]; gastrointestinal reactions, hepatitis and hepatocellular necrosis; CNS reactions; and toxic nephrosis.

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, USP 1% in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

Applies to YOU?

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