Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis. An increased incidence of leukopenia has been reported in patients treated concurrently with cimetidine. Recovery is not influenced by continuation of silver sulfadiazine therapy. Rebound to normal leukocyte levels follows onset within 2 to 3 days. Maximal white blood cell depression occurs within 2 to 4 days of initiation of therapy. 1,2,3 Leukopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. The use of SILVADENE Cream 1% (silver sulfadiazine) in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur. However, the incidence of clinically reported fungal superinfection is low. 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.įungal proliferation in and below the eschar may occur. There is potential cross-sensitivity between silver sulfadiazine and other sulfonamides. 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 gastrointestinal reactions hepatitis and hepatocellular necrosis CNS reactions and toxic nephrosis. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur. Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.Ībsorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.Īlways consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.Results of In Vitro Testing with SILVADENE ® Cream 1% (silver sulfadiazine) Concentration of Silver Sulfadiazine Number of Sensitive Strains/Total Number of Strains Tested Genus & Species Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. Multisource drug products listed under the same heading (e.g. Products meeting necessary bioequivalence requirements. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.Ī Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.Įxclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation.
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