Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Silver Sulfadiazine
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
WARNINGS SECTION
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.